| 1 |
NCT03565549 |
Not yet recruiting |
VAGABOND: a Mnemonic to Aid in the Memory Retention of the Canadian CT Head Rule |
- Traumatic Brain Injury
- Education
|
- Behavioral: Mnemonic
- Behavioral: CCHR rule
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Other
|
- memory retention of the Canadian CT Head Rule
|
500 |
All |
20 Years to 30 Years (Adult) |
NCT03565549 |
SultanQU |
|
September 1, 2018 |
April 1, 2019 |
May 1, 2019 |
June 21, 2018 |
June 25, 2018 |
|
|
|
| 2 |
NCT03515967 |
Recruiting |
Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups |
- Brain Injuries, Traumatic
|
|
Interventional
|
Not Applicable |
- University of Miami
- INC Research
- Neuro Kinetics
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of participants with mTBI
- Time to recover
|
1000 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT03515967 |
20170209 |
|
March 19, 2018 |
December 9, 2021 |
March 9, 2022 |
May 4, 2018 |
May 9, 2018 |
|
- Hecht Athletic Center
Miami, Florida, United States
|
|
| 3 |
NCT03562104 |
Not yet recruiting |
Swallowing Disorders in Minimally Consciousness Patients (MCS) |
- Swallowing Disorder
- Traumatic Brain Injury
|
- Other: videofluoroscopy
- Other: Wessex Head Injury Matrix scale
|
Interventional
|
Not Applicable |
- University Hospital, Rouen
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Stages of swallowing disorders
- Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder
|
50 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03562104 |
2016/379 HP |
TC-DEG |
September 1, 2018 |
January 1, 2019 |
June 1, 2019 |
June 19, 2018 |
June 19, 2018 |
|
- Centre les Herbiers
Bois-Guillaume, France - UH Rouen
Rouen, France
|
|
| 4 |
NCT03313505 |
Not yet recruiting |
PROtein S100B for Mild Trauma of the HEad in Emergency Patients |
- Mild Traumatic Brain Injury
|
- Biological: S100B protein dosage
- Other: Brain CT scan
|
Observational
|
|
- Centre Hospitalier Princesse Grace
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Evaluation of the number of brain CT-scan saved in patients who have been tested for S100B protein
- Comparison of supported patients with S100B protein assay or without S100B protein assay
- Intensive treatment comparison of the patients included in the centers that carried out an "intensive implementation" of the use of the S100B protein and those included in the centers that provided the S100B protein
- Quantification and evaluation of deviations to the algorithm
|
784 |
All |
18 Years and older (Adult, Older Adult) |
NCT03313505 |
16-09
2016-A00901-50 |
PROMETHEE |
November 2017 |
November 2018 |
November 2018 |
October 18, 2017 |
October 18, 2017 |
|
- Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France - AP-HP Centre Hospitalier Universitaire Henri-Mondor
Créteil, France - Hospices Civils de Lyon - Pôle Est
Lyon, France - (and 12 more...)
|
|
| 5 |
NCT02762539 |
Recruiting |
Omega3 PUFA in Head Trauam |
|
- Drug: omega-3 enriched SMOF lipid emusion
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Glasgow coma scale after 48 hour of infusion
|
70 |
All |
20 Years to 50 Years (Adult) |
NCT02762539 |
Omega 3 head injury |
SMOFbrain |
June 2016 |
January 2018 |
January 2018 |
May 5, 2016 |
November 28, 2017 |
|
- Mansoura university
Al Manşūrah, Dkahleya, Egypt
|
|
| 6 |
NCT03034031 |
Not yet recruiting |
MR Imaging Study of TBI in Children |
- TBI (Traumatic Brain Injury)
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Functional MRI
- Structural MRI
- neuropsychological tests
- Associations between the cognitive performance and the imaging methods
|
60 |
All |
9 Years to 18 Years (Child, Adult) |
NCT03034031 |
3211-16-SMC |
MISTIC |
January 2017 |
June 2022 |
June 2022 |
January 27, 2017 |
January 31, 2017 |
|
|
|
| 7 |
NCT03280485 |
Recruiting |
Validation of the Scandinavian Guidelines for Management of TBI in Adults |
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Neurosurgery
- Intracranial complication
- serious CT findings
- CT findings
|
3000 |
All |
18 Years and older (Adult, Older Adult) |
NCT03280485 |
no number |
|
September 10, 2017 |
December 31, 2020 |
December 31, 2021 |
September 12, 2017 |
September 25, 2017 |
|
- Halland Hospital Halmstad
Halmstad, Sweden
|
|
| 8 |
NCT03539848 |
Recruiting |
Diagnosis of mTBI in a Community Setting |
- Traumatic Brain Injury
- Mild Traumatic Brain Injury
- Brain Injuries
- (and 2 more...)
|
|
Interventional
|
Not Applicable |
- University of Miami
- Neuro Kinetics
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of participants with mTBI
- Time to recover
|
400 |
All |
18 Years to 50 Years (Adult) |
NCT03539848 |
20180012 |
|
August 1, 2018 |
March 30, 2021 |
March 30, 2021 |
May 28, 2018 |
September 7, 2018 |
|
- University of Miami Miller School of Medicine
Miami, Florida, United States - University of Miami
Miami, Florida, United States
|
|
| 9 |
NCT03342612 |
Recruiting |
Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury |
- Mild Traumatic Brain Injury
|
- Procedure: Brain Magnetic Resonance Imaging (MRI)
|
Interventional
|
Not Applicable |
- University Hospital, Bordeaux
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Fractional anisotropy (FA) measure
- Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
- Radial diffusivity (RD) measure
- (and 9 more...)
|
60 |
Male |
18 Years to 25 Years (Adult) |
NCT03342612 |
CHUBX2016/07 |
CHANGE-TBI |
July 18, 2016 |
July 18, 2019 |
July 18, 2019 |
November 17, 2017 |
November 17, 2017 |
|
- University Hospital Bordeaux
Bordeaux, France
|
|
| 10 |
NCT02867137 |
Recruiting |
Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients |
|
|
Observational
|
|
- University of Aarhus
- Central Denmark Region
- Aarhus University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
- Specificity of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
- Positive predictive value of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
- (and 5 more...)
|
500 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT02867137 |
Protokol_v2_270616_PreTBI_I |
PreTBI I |
February 15, 2017 |
June 1, 2018 |
June 1, 2019 |
August 15, 2016 |
October 26, 2017 |
|
- Prehospital Emergency Medical Services, Central Denmark Region
Aarhus N, Denmark
|
|
| 11 |
NCT01402882 |
Recruiting |
Clinical Randomisation of an Antifibrinolytic in Significant Head Injury |
|
|
Interventional
|
Phase 3 |
- London School of Hygiene and Tropical Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The primary outcome is death in hospital in patients recruited within 3 hours and cause of death will be described.
- (a) Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis)
- (b) In hospital disability assessed using the Disability Rating Scale and Patient Orientated Outcome
- (and 4 more...)
|
13000 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01402882 |
ISRCTN15088122 |
CRASH-3 |
September 2011 |
January 2019 |
April 2020 |
July 26, 2011 |
March 7, 2018 |
|
- High Technology Medical Center, University Clinic
Tblisi, Georgia
|
|
| 12 |
NCT03482206 |
Not yet recruiting |
Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury |
|
- Device: Automated extracranial internal carotid artery ultrasound sensor
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Internal carotid artery blood flow
- End tidal CO2 level
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT03482206 |
HUM00137659 |
|
January 15, 2019 |
June 30, 2019 |
December 31, 2019 |
March 29, 2018 |
August 28, 2018 |
|
|
|
| 13 |
NCT02223728 |
Recruiting |
Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury |
|
- Behavioral: Lifestyle
- Behavioral: Health Education
|
Interventional
|
Not Applicable |
- University of Alabama at Birmingham
- U.S. Department of Education
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Body Mass Index (BMI) scores
|
80 |
All |
19 Years and older (Adult, Older Adult) |
NCT02223728 |
H133A120096 |
ProjectLIFT |
August 2014 |
October 2018 |
October 2018 |
August 22, 2014 |
November 17, 2017 |
|
- University of Alabama at Birmingham/Spain Rehabilitation Center
Birmingham, Alabama, United States
|
|
| 14 |
NCT03653728 |
Not yet recruiting
New |
Near Infra-red Spectroscopy for Detection of Intracranial Haematoma |
- Traumatic Brain Injury
- Intracerebral Hemorrhage
|
- Device: Near infrared spectroscopy
|
Observational
|
|
- Chinese University of Hong Kong
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation coefficient
- 30 days mortality
- modified Rankin Scale
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT03653728 |
NTEC-2018-0106 |
|
April 1, 2019 |
March 31, 2020 |
March 31, 2021 |
August 31, 2018 |
August 31, 2018 |
|
- Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, Hong Kong
Hong Kong, Hong Kong
|
|
| 15 |
NCT02215187 |
Recruiting |
Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries |
|
- Behavioral: Problem-Solving Training (PST)
- Behavioral: Attention Control
|
Interventional
|
Not Applicable |
- University of Alabama at Birmingham
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Patient Health Questionnaire-9
|
130 |
All |
19 Years and older (Adult, Older Adult) |
NCT02215187 |
#000435754
H133G110275 |
|
July 2013 |
September 2018 |
September 2018 |
August 13, 2014 |
December 15, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States
|
|
| 16 |
NCT02392975 |
Recruiting |
Fast MR for Young Children With Traumatic Brain Injury |
- TBI (Traumatic Brain Injury)
|
- Procedure: Fast MR
- Procedure: Computed Tomography
|
Interventional
|
Not Applicable |
- University of Colorado, Denver
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Diagnostic utility (sensitivity/specificity) of fast MR to identify radiographic evidence of trauma as determined by dual, independent review by 2 masked pediatric neuroradiologists
- Accuracy of fast MR to determine type and location of injury as determined by dual, independent review by 2 masked pediatric neuroradiologists and compared to the clinical interpretation of CT (the current criterion standard).
- Completion rate: determined by the number of fast MR's completed per protocol parameters (all sequences completed in <30 minutes; no request to stop imaging from physician, patient or family)
- Imaging time as determined by the time to complete all images - timer embedded in MR device
|
400 |
All |
up to 72 Months (Child) |
NCT02392975 |
14-1917 |
|
April 2015 |
October 2018 |
November 2018 |
March 19, 2015 |
January 29, 2018 |
|
- University of Colorado School of Medicine
Aurora, Colorado, United States
|
|
| 17 |
NCT02911675 |
Not yet recruiting |
Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury |
|
- Device: EVD/IVC and the IPM/Camino
|
Observational
|
|
- University of Maryland
- United States Air Force
|
Other / U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.
- Compare clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02911675 |
HP-00064113 |
Dual ICP |
December 2018 |
December 2020 |
December 2022 |
September 22, 2016 |
July 12, 2018 |
|
|
|
| 18 |
NCT03215082 |
Not yet recruiting |
Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury |
- Mild Traumatic Brain Injury; Concussion
|
- Other: Vestibular-Visual Intervention
- Behavioral: standard care
|
Interventional
|
Not Applicable |
- McGill University Health Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
465 |
All |
6 Years to 50 Years (Child, Adult) |
NCT03215082 |
2018-3373 |
SiMPly Rehab |
October 2017 |
October 2020 |
December 2020 |
July 12, 2017 |
July 12, 2017 |
|
- Montreal Children's Hospital, MUHC
Montreal, Quebec, Canada
|
|
| 19 |
NCT02924649 |
Recruiting |
Early Mobilisation After Severe Traumatic Brain Injury |
|
- Procedure: Early Intensive mobilisation
|
Interventional
|
Not Applicable |
- Rigshospitalet, Denmark
- University Hospital Bispebjerg and Frederiksberg
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Feasibility outcome
- Coma Recovery Scale - Revised (CRS-R)
- Early Functional Ability (EFA)
- (and 4 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT02924649 |
H-16030775 |
|
January 2017 |
May 2019 |
September 2019 |
October 5, 2016 |
November 21, 2017 |
|
- Rigshospitalet,
Copenhagen, Denmark
|
|
| 20 |
NCT02639923 |
Recruiting |
The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury |
- Brain Injuries, Traumatic
|
- Procedure: Drawing of 7ml peripheral blood
|
Observational
|
|
- Harald Wolf, MD
- Medical Scientific Fund of the Mayor of Vienna
- Medical University of Vienna
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT02639923 |
Wolf-7 |
mRNA |
January 2016 |
March 2017 |
July 2017 |
December 28, 2015 |
March 27, 2017 |
|
- Medical University of Vienna
Vienna, Austria
|
|
| 21 |
NCT03451058 |
Recruiting |
Integrated Eye Tracking and Neural Monitoring for TBI: Optimization |
|
|
Observational
|
|
- United States Naval Medical Center, San Diego
- Uniformed Services University of the Health Sciences
- The Defense and Veterans Brain Injury Center
|
U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- EEG
- Eye Tracking
- Neurobehavioral Symptom Inventory (NSI)
- (and 3 more...)
|
100 |
All |
18 Years to 55 Years (Adult) |
NCT03451058 |
NMCSD.2017.0012 |
|
July 7, 2017 |
September 1, 2018 |
September 1, 2018 |
March 1, 2018 |
May 25, 2018 |
|
- Naval Medical Center San Diego
San Diego, California, United States
|
|
| 22 |
NCT01132937 |
Recruiting |
Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury |
|
|
Observational
|
|
- National Institute of Neurological Disorders and Stroke (NINDS)
- Center for Neuroscience and Regenerative Medicine (CNRM)
- United States Department of Defense
- (and 2 more...)
|
NIH / U.S. Fed / Other |
- Time Perspective: Prospective
|
- Evidence of injury on MRI of the brain vasculature. Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, cognitive impairment, cognitive decline and TBI outcome s...
- Cognitive impairment or decline; success/failure rate for acute MRI in relationship to attempted and those able to undergo CT; imaging findings on CT in comparison to that of MRI; Neurocognitive testing and TBI Outcome Scales.
|
1020 |
All |
18 Years and older (Adult, Older Adult) |
NCT01132937 |
100122
10-N-0122 |
|
July 1, 2010 |
|
|
May 28, 2010 |
August 9, 2018 |
|
- Washington Hospital Center
Washington, District of Columbia, United States - Suburban Hospital
Bethesda, Maryland, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 23 |
NCT02169310 |
Recruiting |
Neural Basis of Decision-Making Deficits in Traumatic Brain Injury |
|
|
Observational
|
|
- National Institute of Neurological Disorders and Stroke (NINDS)
- Uniformed Services University of the Health Sciences
- National Institutes of Health Clinical Center (CC)
|
NIH / U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Performance in a computerized decision making task.
|
80 |
All |
18 Years to 60 Years (Adult) |
NCT02169310 |
140083
14-N-0083 |
|
June 19, 2014 |
August 3, 2019 |
March 1, 2020 |
June 23, 2014 |
August 16, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 24 |
NCT03529799 |
Recruiting |
Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI) |
- Mild Traumatic Brain Injury
|
|
Interventional
|
Not Applicable |
- University of Miami
- Neuro Kinetics
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Feasibility of expanded frequencies for vergence testing
- Toxicity Level Associated with Goggle Use
- Vergence Testing Values
- Comparing Vergence Testing Values
|
60 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03529799 |
20180058 |
|
April 20, 2018 |
April 20, 2019 |
May 20, 2019 |
May 18, 2018 |
May 22, 2018 |
|
- University of Miami
Miami, Florida, United States
|
|
| 25 |
NCT02993549 |
Not yet recruiting |
TBI Multimodal Monitoring Study |
- Traumatic Brain INjury
- Microdialysis
|
|
Observational
|
|
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- LPR <25
- Different pathological targets
- Monitoring correlation
- (and 3 more...)
|
100 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02993549 |
A094233 |
monTBI |
October 2017 |
January 2022 |
October 2022 |
December 15, 2016 |
May 8, 2017 |
|
- Cambridge University Hospital NHS Trust
Cambridge, Cambridgeshire, United Kingdom
|
|
| 26 |
NCT03191357 |
Recruiting |
Evaluation of Military Service and Family Members for Post Concussive and Posttraumatic Stress Symptoms |
- TBI (Traumatic Brain Injury)
|
|
Observational
|
|
- Uniformed Services University of the Health Sciences
- Center for Neuroscience and Regenerative Medicine (CNRM)
|
U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Broad-spectrum military subject recruitment database
- Improvement of recruitment methods
- Enrollment and referral
- Recruitment databases
|
2000 |
All |
18 Years and older (Adult, Older Adult) |
NCT03191357 |
MED-83-2622 |
MRP |
March 2014 |
July 2019 |
July 2020 |
June 19, 2017 |
May 4, 2018 |
|
- Uniformed Services University of Health Sciences (USUHS)
Bethesda, Maryland, United States
|
|
| 27 |
NCT02754063 |
Recruiting |
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury |
- Brain Injuries, Traumatic
|
- Device: PbtO2 probes
- Other: No PbtO2 probes
|
Interventional
|
Not Applicable |
- University Hospital, Grenoble
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) blind assessed
- Neurological outcome according to the extended Glasgow Outcome Scale (GOSE) and Disability Rating Scale
- Disability Rating Scale (DRS)
- (and 4 more...)
|
300 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02754063 |
38RC14.039 |
OXY-TC |
June 2016 |
December 2019 |
December 2020 |
April 28, 2016 |
April 24, 2018 |
|
- General Hospital of Annecy
Annecy, France - University Hospital Besançon
Besançon, France - University Hospital of Bordeaux
Bordeaux, France - (and 21 more...)
|
|
| 28 |
NCT03032302 |
Recruiting |
Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI |
|
- Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin
- Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil
|
Interventional
|
Not Applicable |
- Sheffield Hallam University
- Sheffield Teaching Hospitals NHS Foundation Trust
- Rotherham Doncaster and South Humber NHS Foundation Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Supportive Care
|
- Performance on cognitive test measures (a battery of standardized tests; memory, executive function, social cognition, general intelligence, learning and processing speed)
- Average dietary intake of micronutrients and fatty acids
|
60 |
All |
18 Years to 60 Years (Adult) |
NCT03032302 |
STH19529 |
|
October 1, 2017 |
September 2018 |
September 2019 |
January 26, 2017 |
October 5, 2017 |
|
- Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom
|
|
| 29 |
NCT01633268 |
Recruiting |
Estimating Brain Biomechanics Using MRI |
- Healthy Volunteer
- Traumatic Brain Injury
- Brain Mapping
- (and 2 more...)
|
|
Observational
|
|
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Develop improved MR imaging acquisition protocols for fast imaging of brain motion
- Acquire preliminary data needed for computer simulations of the mechanical response of the brain
- Characterize the stress and strain in specific brain structures during a mild head acceleration
|
90 |
All |
18 Years to 50 Years (Adult) |
NCT01633268 |
120139
12-CC-0139 |
|
June 5, 2012 |
|
|
July 4, 2012 |
August 9, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 30 |
NCT03339505 |
Recruiting |
Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury |
|
- Dietary Supplement: Salovum
- Dietary Supplement: Placebo
|
Interventional
|
Phase 3 |
- Peter Siesjö
- University of Stellenbosch
- Skane University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- 30 day mortality
- TIL - Treatment Intensity Level
- ICP - Intracranial Pressure
|
100 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03339505 |
Ethics Reference #: M16/10/040 |
SASAT |
September 17, 2017 |
March 17, 2019 |
April 30, 2019 |
November 13, 2017 |
November 13, 2017 |
|
- Department of Neurosurgery, Tygerberg Hospital, Francie Van Zijl Dr
Cape Town, South Africa
|
|
| 31 |
NCT03084211 |
Recruiting |
Prescribed Light Exercise for ED Patients With MTBI |
- Mild Traumatic Brain Injury
|
- Other: Light exercise discharge instructions
|
Interventional
|
Not Applicable |
- Mount Sinai Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- proportion of patients with PCS
- Change in RPQ from baseline
- Days of school or work missed
- Return visits to a health care provider
|
300 |
All |
18 Years to 64 Years (Adult) |
NCT03084211 |
MSHED002 |
|
June 19, 2017 |
October 31, 2019 |
December 31, 2019 |
March 20, 2017 |
June 28, 2017 |
|
- Mount Sinai Hospital
Toronto, Ontario, Canada
|
|
| 32 |
NCT03035838 |
Not yet recruiting |
Importance of Substance P in Intracranial Pressure Elevation Following Traumatic Brain Injury |
|
|
Interventional
|
Early Phase 1 |
- Arun Gupta
- Cambridge University Hospitals NHS Foundation Trust
- University of Cambridge
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Reduction in intracranial pressure
- Improvement in brain tissue oxygen tension
- Improvement in lactate/pyruvate ratio on microdialysis monitoring
|
15 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03035838 |
212176 |
NK1 |
September 2017 |
December 2018 |
April 2019 |
January 30, 2017 |
May 3, 2017 |
|
|
|
| 33 |
NCT02504866 |
Recruiting |
Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI |
|
|
Interventional
|
Phase 1
Phase 2 |
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in cognitive function (TMT-B)
- Change in cardiorespiratory fitness
- Change in motor assessment
|
80 |
All |
18 Years to 79 Years (Adult, Older Adult) |
NCT02504866 |
150164
15-CC-0164 |
|
December 15, 2016 |
December 31, 2018 |
December 30, 2019 |
July 22, 2015 |
August 9, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 34 |
NCT02233413 |
Recruiting |
Light Therapy for Moderate Traumatic Brain Injury |
- Moderate Traumatic Brain Injury (TBI)
|
- Device: Active LLLT helmet application
- Device: Non-active LLLT helmet application
|
Interventional
|
Not Applicable |
- Massachusetts General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Safety and feasibility of applying light therapy after moderate TBI
- Neuroreactivity of light therapy to the injured brain based on MRI
- Neuroreactivity of light therapy to the injured brain based on neurcognitive function
|
90 |
All |
18 Years and older (Adult, Older Adult) |
NCT02233413 |
2013P000430
W81XWH-13-2-0067 CDMRP |
LLLT for TBI |
June 2014 |
December 2018 |
December 2018 |
September 8, 2014 |
May 17, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 35 |
NCT02959294 |
Recruiting |
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries |
- Traumatic Encephalopathies, Chronic
- Concussion, Mild
- Concussion, Intermediate
- (and 2 more...)
|
- Procedure: Microcannula Harvest Adipose
- Device: Centricyte 1000
- Procedure: Sterile Normal Saline IV deployment AD-cSVF
|
Interventional
|
Phase 1
Phase 2 |
- Robert W. Alexander, MD, FICS
- Healeon Medical Inc
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with adverse events
- Cognitive Change in clinical symptoms associated with concussion-TBI
- Beck's Depression Inventory (BDI)
- (and 2 more...)
|
200 |
All |
16 Years to 70 Years (Child, Adult, Older Adult) |
NCT02959294 |
RGV GARM 5 |
C-TBI |
November 2016 |
November 2021 |
November 2021 |
November 9, 2016 |
September 12, 2017 |
|
- Regenevita LLC
Stevensville, Montana, United States - Regenevita LLC
Stevensville, Montana, United States
|
|
| 36 |
NCT03306563 |
Recruiting |
Rapid Biochemical Diagnostics of Traumatic Brain Injury |
- Traumatic Brain Injury
- Concussion, Mild
- Bone Fracture
|
- Diagnostic Test: Sample collection
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Diagnostic
|
|
160 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03306563 |
T213/2017 |
|
December 7, 2017 |
December 2018 |
December 2018 |
October 11, 2017 |
August 31, 2018 |
|
- Satakunta Central Hospital
Pori, Finland - Turku University Hospital (Tyks)
Turku, Finland - Vaasa Central Hospital
Vaasa, Finland
|
|
| 37 |
NCT03054285 |
Recruiting |
Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates? |
- Seizures
- Traumatic Brain Injury
|
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Seizures (count of seizures)
- Mortality
|
2300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03054285 |
209136 |
|
July 1, 2017 |
April 1, 2020 |
April 1, 2021 |
February 15, 2017 |
August 6, 2018 |
|
- Loyola University Medical Center
Maywood, Illinois, United States
|
|
| 38 |
NCT03515317 |
Not yet recruiting |
Effects of Neurofeedback in Cognitive Deficit in Patients With TBI |
|
- Behavioral: LoRETA Z-score NF
- Behavioral: theta/beta NF
|
Interventional
|
Not Applicable |
- Taipei Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- The changes of cognitive functions about the sustained and selective aspects of visual attention.
- The changes of cognitive functions about the visual memory function.
- The changes of cognitive functions about verbal memory.
- (and 4 more...)
|
96 |
All |
20 Years to 65 Years (Adult, Older Adult) |
NCT03515317 |
N201704027 |
|
May 1, 2018 |
July 31, 2020 |
July 31, 2020 |
May 3, 2018 |
May 3, 2018 |
|
|
|
| 39 |
NCT02988102 |
Recruiting |
Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma |
|
- Other: Following S100B and NSE in head trauma
|
Observational
|
|
- University Clinical Centre of Kosova
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Role of concentration of biomarkers S100B and NSE in serum in mild and moderate head trauma injury in acute phase in relation to head CT and post concusion syndrome.
|
70 |
All |
1 Year to 65 Years (Child, Adult, Older Adult) |
NCT02988102 |
FKelmendi |
|
December 2016 |
December 2016 |
August 2017 |
December 9, 2016 |
December 9, 2016 |
|
- Fatos Kelmendi
Tirana, Kosovo Prishtina, Albania
|
|
| 40 |
NCT02812225 |
Recruiting |
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM) |
- Brain Concussion
- Mild Traumatic Brain Injury
|
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of BrainPulse recordings from suspected and confirmed concussed subjects
- Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects
|
500 |
All |
5 Years and older (Child, Adult, Older Adult) |
NCT02812225 |
JMC-1502 |
|
June 2016 |
December 2018 |
March 2019 |
June 24, 2016 |
September 20, 2018 |
|
- Beth Israel Deconess Medical Center Emergency Medicine
Boston, Massachusetts, United States - University of Cincinnati, Department of Emergency Medicine
Cincinnati, Ohio, United States - Mountain States Health Alliance
Johnson City, Tennessee, United States
|
|
| 41 |
NCT03642158 |
Recruiting |
rTMS for Cognitive Rehabilitation After TBI |
- Cognitive Impairment
- Traumatic Brain Injury
|
- Device: repetitive Transcranial Magnetic Stimulation
|
Interventional
|
Not Applicable |
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Virginia Commonwealth Neurotrauma Initiative
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Auditory target detection task
- Ruffs 2 and 7 selective attention test
- DKEFS Verbal Fluency
- (and 2 more...)
|
40 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03642158 |
02332 |
|
December 1, 2017 |
June 30, 2020 |
June 30, 2020 |
August 22, 2018 |
August 22, 2018 |
|
- Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
|
|
| 42 |
NCT02798601 |
Not yet recruiting |
Early Induced Hypernatremia for the Prevention and Management of Brain Edema |
|
|
Interventional
|
Not Applicable |
- Hospital Pablo Tobón Uribe
- CES University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Glasgow Outcome Scale Extended
- All-cause mortality
- Ventilator - Free Days
- (and 6 more...)
|
278 |
All |
14 Years and older (Child, Adult, Older Adult) |
NCT02798601 |
U1111-1183-0891
HPTU |
EHIBE |
October 2018 |
August 2022 |
December 2022 |
June 14, 2016 |
August 10, 2017 |
|
|
|
| 43 |
NCT01315379 |
Recruiting |
Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury |
- PTSD
- Traumatic Brain Injury
- Post Concussive Syndrome
|
- Behavioral: Prolonged Exposure Therapy
|
Observational
|
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Percentage of participants with PTSD diagnosis as a measure of recovery rates
- Change from Baseline in Neuropsychological Functioning at Treatment Completion
- Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
- (and 7 more...)
|
60 |
All |
6 Years to 18 Years (Child, Adult) |
NCT01315379 |
6166 |
TBI |
April 2011 |
March 2017 |
March 2017 |
March 15, 2011 |
October 11, 2016 |
|
- Schneider Children's Medical Center of Israel
Petach Tikva, Israel
|
|
| 44 |
NCT03654014 |
Recruiting
New |
NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study |
|
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- CSF and serum biomarkers
- Glasgow Coma Score
- Glasgow Outcome Score Extended
- Modified Rankin Scale
|
45 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT03654014 |
14-113 |
|
September 1, 2018 |
August 17, 2019 |
November 1, 2019 |
August 31, 2018 |
August 31, 2018 |
|
- University of New Mexico
Albuquerque, New Mexico, United States
|
|
| 45 |
NCT02356861 |
Recruiting |
LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans |
- Traumatic Brain Injury (TBI)
- Post-traumatic Stress Disorder (PTSD)
|
- Device: Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Stroop Test ("Color-Word" test) (Delis, Kaplan & Kramer, 2001)
- Digit Span Subtests (WAIS-IV; Wechsler, 2008) D-KEF Trails (Delis, Kaplan & Kramer, 2001)
- California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)
- (and 2 more...)
|
50 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02356861 |
D1768-P
1I21RX001768-01 |
|
March 1, 2016 |
March 1, 2019 |
March 1, 2019 |
February 5, 2015 |
August 23, 2018 |
|
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
|
|
| 46 |
NCT03266380 |
Not yet recruiting |
Risk Factors and Common Preventive Measures for Ventilator Associated Pneumonia in Patients With Severe Traumatic Brain Injury |
- Ventilator Associated Pneumonia
|
- Diagnostic Test: observational
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury
|
80 |
All |
10 Years to 70 Years (Child, Adult, Older Adult) |
NCT03266380 |
VAP |
|
January 1, 2018 |
December 1, 2019 |
December 30, 2019 |
August 30, 2017 |
September 8, 2017 |
|
|
|
| 47 |
NCT03671083 |
Not yet recruiting
New |
Validation of Brain Function Assessment Algorithm for mTBI From Initial Injury to Rehabilitation |
- Brain Injuries, Traumatic
- Concussion, Mild
- Concussion, Severe
- Concussion, Intermediate
|
- Device: BrainScope Ahead300iP Evaluation
|
Observational
|
|
|
Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Sensitivity and Specificity
|
320 |
All |
13 Years to 25 Years (Child, Adult) |
NCT03671083 |
52-Ahead |
CAS 13-25 |
September 30, 2018 |
January 1, 2019 |
January 1, 2019 |
September 14, 2018 |
September 14, 2018 |
|
- University of Arkansas
Fayetteville, Arkansas, United States - University of Miami
Miami, Florida, United States - Michigan State University
East Lansing, Michigan, United States - University of Rochester
Rochester, New York, United States
|
|
| 48 |
NCT03465995 |
Recruiting |
Test and Evaluation of Non-Invasive Neuro-Assessment Devices (NINAD: Neurokinetics, Inc, iPAS |
- Traumatic Brain Injury
- Post Traumatic Stress Disorder
|
- Device: NKI i-PAS Diagnostic Protocol
|
Observational
|
|
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- The Citadel, The Military College of North Carolina
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Unit performance reliability
|
200 |
All |
18 Years to 55 Years (Adult) |
NCT03465995 |
MEM 91-2714 |
NINADiPAS |
February 22, 2018 |
February 28, 2019 |
February 28, 2019 |
March 15, 2018 |
August 2, 2018 |
|
- The Citadel
Charleston, South Carolina, United States
|
|
| 49 |
NCT03674398 |
Not yet recruiting
New |
Aerobic Exercise and Cognitive Training Effects on Postconcussive Symptomology |
- Post-Concussion Syndrome
- Post-Traumatic Headache
- Post-Concussive Syndrome, Chronic
- (and 4 more...)
|
- Behavioral: Exercise+CT
- Behavioral: Exercise only
|
Interventional
|
Not Applicable |
- University of Illinois at Urbana-Champaign
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Rivermead Post Concussion Symptoms Questionnaire
- NIH Toolbox Cognition Battery - Working Memory
- NIH Toolbox Cognition Battery - Attention
|
90 |
All |
18 Years and older (Adult, Older Adult) |
NCT03674398 |
18814 |
|
October 1, 2018 |
May 1, 2019 |
May 1, 2019 |
September 17, 2018 |
September 17, 2018 |
|
|
|
| 50 |
NCT02354469 |
Recruiting |
The Effects of Head Trauma on Collegiate Athletes |
- Cerebral Concussion
- Brain Injuries
|
|
Observational
|
|
- Boston Children’s Hospital
- Harvard University
- Beth Israel Deaconess Medical Center
- (and 2 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Dynamic Balance Control
- Cognitive Function
- EEG signals
- (and 2 more...)
|
300 |
All |
18 Years to 25 Years (Adult) |
NCT02354469 |
IRB-P00016469 |
|
August 2015 |
August 2020 |
August 2020 |
February 3, 2015 |
February 27, 2018 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
|
| 51 |
NCT03441867 |
Recruiting |
Neuroimaging Biomarker for Seizures |
- Seizure Disorder
- Seizure Disorder, Post Traumatic
- Traumatic Brain Injury
- (and 3 more...)
|
- Behavioral: Cognitive Behavioral Therapy for Seizures
- Other: Standard Medical Care
|
Interventional
|
Not Applicable |
- Providence VA Medical Center
- University of Alabama at Birmingham
- Rhode Island Hospital
- (and 4 more...)
|
U.S. Fed / Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Epileptic Seizures
- Number of Nonepileptic Seizures (NES)
- Structural and Functional Neuroimaging
- (and 3 more...)
|
264 |
All |
18 Years to 60 Years (Adult) |
NCT03441867 |
Award Number W81XWH-17-1-0619 |
NIBMSZS |
September 15, 2017 |
March 2021 |
August 31, 2021 |
February 22, 2018 |
March 20, 2018 |
|
- University of Alabama, Birmingham
Birmingham, Alabama, United States - Rhode Island Hospital
Providence, Rhode Island, United States - Providence VA Medical Center
Providence, Rhode Island, United States
|
|
| 52 |
NCT02061553 |
Recruiting |
SMS Messaging to Reduce Depression and Anxiety Following TBI |
|
- Behavioral: Motivation
- Behavioral: Intention
- Behavioral: BA-Tech
|
Interventional
|
Not Applicable |
- Albert Einstein Healthcare Network
- National Institute on Disability, Independent Living, and Rehabilitation Research
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline on Brief Symptom Inventory-18 (BSI-18) Global Severity Index
|
119 |
All |
18 Years and older (Adult, Older Adult) |
NCT02061553 |
TBIMS HN4473
H133A120037 |
|
October 22, 2013 |
May 16, 2022 |
September 16, 2022 |
February 13, 2014 |
September 3, 2018 |
|
- Moss Rehabilitation Research Institue
Elkins Park, Pennsylvania, United States
|
|
| 53 |
NCT02756585 |
Not yet recruiting |
Computed Tomography Perfusion in Patients With Severe Head Injury |
|
|
Interventional
|
Not Applicable |
- Nova Scotia Health Authority
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02756585 |
CTP TBI |
|
September 2016 |
September 2018 |
December 2018 |
April 29, 2016 |
April 29, 2016 |
|
- Queen Elizabeth II Health Sciences Centre-Halifax Infirmary
Halifax, Nova Scotia, Canada
|
|
| 54 |
NCT03391583 |
Not yet recruiting |
Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury? |
- Headache Disorders
- Post-Concussion Syndrome
- Mild Traumatic Brain Injury
|
|
Interventional
|
Not Applicable |
- St. Michael's Hospital, Toronto
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Survey response
- Rivermead post concussion questionnaire scores (RPQ)
- Access to health care
- (and 2 more...)
|
70 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03391583 |
Grant 17-0098-GAP |
|
January 8, 2018 |
December 17, 2018 |
June 1, 2019 |
January 5, 2018 |
January 5, 2018 |
|
|
|
| 55 |
NCT03441776 |
Recruiting |
Towards Comparative Effectiveness in Military Vestibular Rehabilitation |
- Vestibular Problem
- Traumatic Brain Injury
|
- Other: Generalized Vestibular Rehabilitation Treatment
- Other: Individualized Vestibular Rehabilitation Treatment
|
Interventional
|
Not Applicable |
- Jorge Arango
- The Defense and Veterans Brain Injury Center
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Dizziness Handicap Inventory (DHI) score
- Change in Activities-specific Balance Confidence (ABC) Scale
- Change in Equilibrium Score on Sensory Organization Test (SOT)
- (and 6 more...)
|
60 |
All |
18 Years to 49 Years (Adult) |
NCT03441776 |
RHC-A-18-006 |
|
February 9, 2018 |
February 2019 |
February 2019 |
February 22, 2018 |
February 22, 2018 |
|
- Warrior Recovery Center, Evans Army Community Hospital
Fort Carson, Colorado, United States
|
|
| 56 |
NCT03453749 |
Not yet recruiting |
Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury |
- Head Trauma
- Intensive Care Neurological Disorder
- Edema Brain
|
- Dietary Supplement: Salovum
|
Interventional
|
Phase 2 |
- Peter Siesjö
- Skane University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ICP
- PtO2
- Microdialysis biochemistry
- (and 2 more...)
|
5 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03453749 |
Ethics reference: 2013/144 |
SATSWEDEN |
March 15, 2018 |
June 2018 |
December 2018 |
March 5, 2018 |
March 14, 2018 |
|
|
|
| 57 |
NCT01860404 |
Recruiting |
BCAA's in Concussion |
|
- Drug: Branched Chain Amino Acids
- Drug: Placebo solution
|
Interventional
|
Phase 2 |
- Children's Hospital of Philadelphia
- The Dana Foundation
- Main Line Health
- University of Pennsylvania
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reaction time difference between drug and placebo groups
- Clinical symptoms
- Return to school and sports
- (and 4 more...)
|
50 |
All |
11 Years to 34 Years (Child, Adult) |
NCT01860404 |
13-10227 |
HIT HEADS |
January 2014 |
January 2019 |
January 2019 |
May 22, 2013 |
July 20, 2018 |
|
- The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 58 |
NCT03498495 |
Not yet recruiting |
Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury |
- Brain Injury Traumatic Mild
|
- Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)
|
Interventional
|
Not Applicable |
- Children's Hospital Medical Center, Cincinnati
- University of Cincinnati
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Change in Psychological Distress, as measured by the Strengths and Difficulties Questionnaire (SDQ)
- Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)
- Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)
- (and 4 more...)
|
100 |
All |
11 Years to 18 Years (Child, Adult) |
NCT03498495 |
CIN001--SMART |
SMART |
July 2018 |
July 2019 |
August 2019 |
April 13, 2018 |
April 13, 2018 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 59 |
NCT03367507 |
Not yet recruiting |
Sub-maximal Exercise Prescription in Adolescents With Physiological Post-concussion Disorder |
- Physiological Post-Concussion Disorder
- Post-Concussion Syndrome
- Traumatic Brain Injury
- (and 3 more...)
|
- Behavioral: Sub-symptom aerobic exercise
|
Interventional
|
Not Applicable |
- Sport Injury Prevention Research Centre
- University of Manitoba
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Days to receive medical clearance to return to sport
- Pediatric Quality Of Life score (PedsQL)
- Sport Concussion Assessment tool 5 (symptom scores)
- (and 5 more...)
|
136 |
All |
13 Years to 19 Years (Child, Adult) |
NCT03367507 |
REB17-0570 |
|
December 10, 2017 |
June 2019 |
November 2019 |
December 8, 2017 |
December 8, 2017 |
|
- University of Calgary
Calgary, Alberta, Canada - Pan Am Sports Medicine Clinic
Winnipeg, Manitoba, Canada
|
|
| 60 |
NCT03285165 |
Recruiting |
Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients |
|
- Drug: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
- Drug: 10-70 mcg/kg/h propofol infusion.
|
Interventional
|
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Middle cerebral artery flow velocity
|
60 |
All |
18 Years to 50 Years (Adult) |
NCT03285165 |
17200002 |
DEXSEDATION |
September 14, 2017 |
September 2019 |
September 2019 |
September 15, 2017 |
September 15, 2017 |
|
- Assiut university main hospital, Trauma ICU
Assiut, Assiut governorate, Egypt
|
|
| 61 |
NCT03089749 |
Recruiting |
Characterization of Human Autoantibody Titers After Central Nervous System Insult |
- Brain Injuries, Traumatic
- Spinal Cord Trauma
- Intracranial Neoplasm
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Quantitate Autoantibodies
- Autoantibody Correlation
- Autoantibody Production and History
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT03089749 |
CHAT-00081214 |
CHAT CNS |
May 2015 |
August 2018 |
May 2022 |
March 24, 2017 |
October 26, 2017 |
|
- University of Utah Hospital
Salt Lake City, Utah, United States
|
|
| 62 |
NCT02149082 |
Recruiting |
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children |
|
- Device: Infrascanner Model 2000
|
Observational
|
|
- Children's Hospital of Philadelphia
- Boston Children’s Hospital
- Children's Hospital Colorado
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity of NIRS Optical Density (OD) Measurement
- Specificity and Predictive Values of NIRS Measurement
- Variability in Sensitivity and Specificity Based on Hematoma Characteristics
- Age Varying Sensitivity
|
328 |
All |
up to 18 Years (Child, Adult) |
NCT02149082 |
14-010812 |
|
June 2014 |
July 2018 |
July 2018 |
May 29, 2014 |
June 9, 2017 |
|
- Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 63 |
NCT02699346 |
Recruiting |
An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion |
- Brain Concussion
- Brain Injuries
|
- Device: HS-1000 recording
|
Interventional
|
Not Applicable |
- HeadSense Medical
- Vanderbilt University Medical Center
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects
- Determine the correlation between ICP measurements obtained from the HS-1000 device and the clinical findings from the modified Balance Error Score System (mBESS) and ImPACT scores in post-concussion patients.
- To evaluate the ergonomic and functional aspects of using the HS-1000 by having the operators of the device complete a brief 5 question survey about the ease or difficulty in using the device.
|
100 |
All |
13 Years to 25 Years (Child, Adult) |
NCT02699346 |
HS-010 |
|
January 2015 |
June 2017 |
March 2018 |
March 4, 2016 |
December 22, 2016 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
|
| 64 |
NCT02699359 |
Recruiting |
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion |
- Brain Concussion
- Brain Injuries
|
- Device: HS-1000 recording
|
Interventional
|
Not Applicable |
- HeadSense Medical
- Akron Children's Hospital
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of recordings that correlate to concussion diagnosis using current standards
|
100 |
All |
12 Years to 17 Years (Child) |
NCT02699359 |
HS-022 |
|
May 2015 |
June 2017 |
December 2017 |
March 4, 2016 |
December 23, 2016 |
|
- Akron Children's Hospital
Akron, Ohio, United States
|
|
| 65 |
NCT02783105 |
Recruiting |
Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury |
- Paroxysmal Sympathetic Hyperactivity
|
- Other: Musical intervention
- Other: Control
|
Interventional
|
Not Applicable |
- University Hospital, Strasbourg, France
- Fondation Apicil
- MDMS
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29)
- Area under the Clinical Features Scale curve
- Mean Analgesia Nociception Index
- (and 5 more...)
|
100 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02783105 |
6224 |
MUSIC-TCNV |
November 2016 |
June 2020 |
August 2021 |
May 26, 2016 |
November 22, 2016 |
|
- Service d'Anesthésie Réanimation- Hôpital de Hautepierre
Strasbourg, France
|
|
| 66 |
NCT03050970 |
Recruiting |
Infant Minor Head Trauma Clinical Decision Rule |
|
|
Observational
|
|
- Assistance Publique - Hôpitaux de Paris
- GFRUP : Francophone Pediatric Resuscitation and Emergency Group
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Presence of a clinically-important traumatic brain injuries (ciTBI)
- Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
- Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group
- (and 4 more...)
|
10000 |
All |
up to 2 Years (Child) |
NCT03050970 |
2016-A00629-42
NI 15019 - AOM 15311 |
PELICAN |
February 11, 2017 |
July 31, 2018 |
December 31, 2018 |
February 13, 2017 |
April 30, 2018 |
|
- Pediatric Emergency Department - Necker-Enfants malades Hospital -
Paris, France
|
|
| 67 |
NCT00724607 |
Recruiting |
Brain Injury Outcomes (BIO) Study |
- Brain Concussion
- Posttraumatic Stress Disorder
|
|
Observational
|
|
- VA Office of Research and Development
- Boston Children’s Hospital
- Oak Ridge National Laboratory
- (and 2 more...)
|
U.S. Fed / Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Fractional anisotropy (FA)
|
300 |
All |
18 Years to 59 Years (Adult) |
NCT00724607 |
SHP 08-167
01133 |
BIO |
May 6, 2008 |
June 30, 2019 |
June 30, 2019 |
July 29, 2008 |
June 25, 2018 |
|
- Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States
|
|
| 68 |
NCT02019654 |
Recruiting |
An Investigation of the Biological and Neuronal Mechanisms of Post Traumatic Stress Disorder, Depression and Post-Concussive Syndrome Onset Following a Traumatic Brain Injury |
- Traumatic Brain Injury
- Mild Traumatic Brain Injury
|
|
Observational
|
|
- National Institute of Nursing Research (NINR)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Examine proteomic concentrations of inflammatory proteins and neuropeptides following TBI and determine if these biomarkers relate to a greater risk for PTSD, depression or PCS.
- We will investigate the activation and effective connectivity between the amygdala and other target regions regulating emotions by analyzing fMRI data to determine neuronal mechanisms related to PTSD, PCS, and depression onset.
- Examine epigenetic modifications (i.e. DNA methylation) and genetic predisposition using blood and saliva that may relate to the risk for PTSD, depression and PCS onset following a TBI.
|
120 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02019654 |
140032
14-NR-0032 |
|
December 20, 2013 |
July 1, 2019 |
July 1, 2019 |
December 24, 2013 |
August 24, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 69 |
NCT02292589 |
Recruiting |
Brain Stimulation for Mild Traumatic Brain Injury |
- Traumatic Brain Injury
- Post-Concussion Symptoms
|
- Device: Frontal Stimulation
- Device: Temporal Stimulation
- Device: Sham Stimulation
|
Interventional
|
Phase 2 |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Other
|
- Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
|
20 |
All |
18 Years to 60 Years (Adult) |
NCT02292589 |
RAHC-001 |
tDCS/PPCS |
October 2014 |
December 2018 |
April 2019 |
November 17, 2014 |
May 15, 2018 |
|
- HC University of Sao Paulo - Medical School
São Paulo, SP, Brazil
|
|
| 70 |
NCT02771106 |
Recruiting |
Neuroimaging and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury |
- Traumatic Brain Injury
- Vision Difficulty
|
- Other: neuro vision rehabilitation
|
Observational
|
|
- Minneapolis Medical Research Foundation
- University of Minnesota - Clinical and Translational Science Institute
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- To localize changes following mild traumatic brain injury in subjects with vision dysfunction using magnetic resonance imaging (MRI).
- 2) The effectiveness of neuro vision rehabilitation on vision dysfunction initiated within nine months following mTBI will be shown using magnetic resonance imaging by comparing aggregate data of 15 vision dysfunction subjects to 15 control subjects.
|
30 |
All |
16 Years to 55 Years (Child, Adult) |
NCT02771106 |
HSR #13-3702 |
|
June 2016 |
July 2018 |
January 2019 |
May 12, 2016 |
August 30, 2017 |
|
- Hennepin County Medical Cetner
Minneapolis, Minnesota, United States
|
|
| 71 |
NCT02089594 |
Recruiting |
Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS) |
- Post-Concussion Syndrome
- Traumatic Brain Injury
|
- Drug: Hyperbaric Oxygen
- Drug: No Hyperbaric Oxygen
|
Interventional
|
Phase 3 |
- Louisiana State University Health Sciences Center in New Orleans
- U.S. Army Medical Research and Materiel Command
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Working Memory
- Neurobehavioral Symptom Inventory (NSI)
- Wechsler Abbreviated Scale of Intelligence II (WASI-II)
- (and 9 more...)
|
59 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02089594 |
LSU IRB #7381
W81XWH-10-1-0962 |
|
May 2014 |
March 2018 |
March 2019 |
March 18, 2014 |
April 18, 2017 |
|
- Louisiana State University Health Sciences Center-New Orleans
New Orleans, Louisiana, United States
|
|
| 72 |
NCT03237676 |
Recruiting |
The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury |
- Mild Traumatic Brain Injury
- Cognitive Impairment
|
- Other: Structured cognitive rehabilitation therapy
- Other: Patient-centred cognitive therapy
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Neuropsychological Assessment Battery- Screening score
- Change in Diffusion Tensor Imaging parameters
- Change in Goal Attainment Scaling score
|
100 |
All |
18 Years to 60 Years (Adult) |
NCT03237676 |
PO037-2015A |
|
August 1, 2017 |
October 30, 2019 |
December 31, 2019 |
August 2, 2017 |
August 21, 2017 |
|
- University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia
|
|
| 73 |
NCT02634944 |
Recruiting |
The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status |
- Mild Traumatic Brain Injury
|
- Diagnostic Test: Vestibular Ocular Motor Screening Tool (VOMS)
|
Interventional
|
Not Applicable |
- University of Pittsburgh
- United States Department of Defense
|
Other / U.S. Fed |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Reliability of US military corpsmen-level medical personnel (i.e., Special Operation Combat Medics [SOCM], Special Forces Medical Sergeants [18D]) to administer the VOMS to US military personnel in combat and non-combat environments.
- Change in symptoms on the VOMS at acute and sub-acute time periods correlated with recovery times to return to duty (RTD)
|
650 |
All |
18 Years to 40 Years (Adult) |
NCT02634944 |
PRO15090054 |
|
March 16, 2018 |
May 2019 |
May 2019 |
December 18, 2015 |
May 8, 2018 |
|
- First Special Forces Group - JBLM
Fort Lewis, Washington, United States
|
|
| 74 |
NCT03318822 |
Recruiting |
Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport |
- Brain Injuries, Traumatic
- Brain Injury Traumatic Mild
|
|
Observational
|
|
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Tolerability of collar usage
- Compliance of collar usage
|
200 |
All |
14 Years to 49 Years (Child, Adult) |
NCT03318822 |
2016-9625 |
|
August 1, 2017 |
July 30, 2020 |
December 31, 2020 |
October 24, 2017 |
October 24, 2017 |
|
- Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 75 |
NCT02613936 |
Recruiting |
Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury |
- Traumatic Brain Injury
- Post Concussive Symptoms
- Depression
- Executive Dysfunction
|
- Device: Anodal tDCS
- Behavioral: Cognitive training
|
Interventional
|
Not Applicable |
- University of New Mexico
- National Institutes of Health (NIH)
- National Institute of General Medical Sciences (NIGMS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
80 |
All |
18 Years to 55 Years (Adult) |
NCT02613936 |
UNM HRRC #15-124
1P20GM109089-01A1 |
|
September 2015 |
June 2019 |
June 2020 |
November 25, 2015 |
May 8, 2018 |
|
- UNM Center for Brain Recovery and Repair
Albuquerque, New Mexico, United States
|
|
| 76 |
NCT03677661 |
Not yet recruiting
New |
Cervico-vestibular Rehabilitation for Mild Traumatic Brain Injury |
- Post-Concussion Syndrome
- Mild Traumatic Brain Injury
- Vestibular Disorder
- (and 2 more...)
|
- Other: Conventional approach
- Other: Personalized rehabilitation program
|
Interventional
|
Not Applicable |
- Laval University
- Centre interdisciplinaire de recherche en réadaptation et intégration sociale
- Université du Québec à Trois-Rivières
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Post-Concussion Symptoms Scale (PCSS)
- Clearance to return to function
- Numerical Pain Rating Scale (NPRS)
- (and 3 more...)
|
46 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03677661 |
Quebec mTBI |
|
January 1, 2019 |
April 1, 2020 |
October 1, 2020 |
September 19, 2018 |
September 20, 2018 |
|
- Clinique Cortex
Quebec city, Quebec, Canada
|
|
| 77 |
NCT02260570 |
Recruiting |
Remediation of Impaired Self-Regulation in Patients With Mild TBI |
- Mild Traumatic Brain Injury
|
- Drug: Tolcapone
- Drug: Placebo
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
- University of California, Berkeley
- University of California, San Francisco
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Blood Oxygen Level Dependent (BOLD) brain signal measured using functional MRI
- Performance on Cognitive Testing
|
80 |
All |
18 Years to 50 Years (Adult) |
NCT02260570 |
D0825-I
1I01RX000825-01 |
|
August 1, 2015 |
June 29, 2019 |
June 29, 2019 |
October 9, 2014 |
August 21, 2018 |
|
- VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
|
|
| 78 |
NCT03582579 |
Recruiting |
Enhancing Brain Training With Virtual Reality |
- Mild Traumatic Brain Injury
|
- Behavioral: Training in Virtual Reality
- Behavioral: Training on a computer screen
|
Interventional
|
Not Applicable |
- University of Rochester
- Neurotrainer
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Visual Crowding (a measure of spacial resolution of attention)
- Attentional Blink (a measure of temporal resolution of attention)
- Useful Field of View (a measure of spacial awareness)
|
80 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03582579 |
70869 |
|
June 27, 2018 |
August 2019 |
August 2019 |
July 11, 2018 |
July 11, 2018 |
|
- University of Rochester
Rochester, New York, United States
|
|
| 79 |
NCT03345550 |
Recruiting |
OPTIMA-TBI Pilot Study |
- Mild Traumatic Brain Injury
|
- Drug: Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.
- Drug: Placebo - Cap
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Biomarker Endpoints (NFL)
- Biomarker Endpoint (Inflammation)
- Biomarker Endpoint (Neurogenesis)
- (and 3 more...)
|
50 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03345550 |
HUM00129045 |
OPTIMA |
September 12, 2017 |
July 27, 2019 |
July 27, 2019 |
November 17, 2017 |
January 10, 2018 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
|
| 80 |
NCT02922569 |
Recruiting |
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI |
- Mild Traumatic Brain Injury
|
- Other: Computerized Plasticity-Based Adaptive Cognitive Training
- Other: Commercially available computerized training
- Other: Mindfulness Training
- Other: Veterans Affairs Information Session
|
Interventional
|
Not Applicable |
- Posit Science Corporation
- VA Connecticut Healthcare System
|
Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Between-group magnitude of change in processing speed utilizing Pattern-Number Comparison and Digit Symbol Coding.
- Between-group magnitude of change in memory utilizing WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT).
- Between-group magnitude of change in executive function utilizing Trail Making Task, Flanker Task and Stroop Task.
- Between-group magnitude of change in functional status utilizing Timed Instrumental Activities of Daily Living (TIADL)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT02922569 |
PSC-0616-16 |
CogMind |
March 31, 2017 |
December 2019 |
December 2019 |
October 4, 2016 |
June 19, 2018 |
|
- Veterans Affairs Connecticut Health Care System
West Haven, Connecticut, United States
|
|
| 81 |
NCT03319966 |
Recruiting |
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury |
- Mild Traumatic Brain Injury
- Brain Concussion
- Convergence Insufficiency
- (and 3 more...)
|
|
Observational
|
|
- Minneapolis Medical Research Foundation
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Eye Tracker as an Objective Tool for "Yes/No" Assessment of Oculomotor Dysfunction Presence
- Eye Tracking Visual Measurements as Objective Predictor of Neurovision Rehabilitation Effectiveness
|
100 |
All |
13 Years to 55 Years (Child, Adult) |
NCT03319966 |
HSR#17-4409 |
|
October 18, 2017 |
June 2019 |
June 2019 |
October 24, 2017 |
July 17, 2018 |
|
- Hennepin County Medical Center Traumatic Brain Injury Clinic
Minneapolis, Minnesota, United States
|
|
| 82 |
NCT02916108 |
Not yet recruiting |
Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study |
- Concussion, Mild Traumatic Brain Injury
|
|
Observational
|
|
- Rambam Health Care Campus
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Primary objective: Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.
- Secondary objective: Percentage of children with persistent post-concussion symptoms that display a decreased IHDD below 0.7 in the anterior hemispheres.
|
60 |
All |
11 Years to 18 Years (Child, Adult) |
NCT02916108 |
0333-16-RambamCTIL |
|
October 2016 |
December 2019 |
December 2020 |
September 27, 2016 |
September 27, 2016 |
|
|
|
| 83 |
NCT03475693 |
Recruiting |
A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents |
|
- Drug: Magnesium Oxide
- Drug: Acetaminophen
- Drug: Zofran ODT 4 MG Disintegrating Oral Tablet
|
Interventional
|
Early Phase 1 |
- Lakeland Health
- Michigan State University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in symptom severity score
- Adverse events in the emergency department
|
100 |
All |
12 Years to 18 Years (Child, Adult) |
NCT03475693 |
MMMC#1571 |
|
September 1, 2017 |
July 2019 |
November 2019 |
March 23, 2018 |
June 7, 2018 |
|
- Lakeland Regional Healthcare
Saint Joseph, Michigan, United States
|
|
| 84 |
NCT03339037 |
Recruiting |
Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children |
- Hyperbaric Oxygen Therapy
- Traumatic Brain Injury
- Post-Concussion Syndrome
|
- Device: Hyperbaric oxygen therapy
- Device: Normobaric air SHAM
|
Interventional
|
Not Applicable |
- Assaf-Harofeh Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cognitive function
- Post concussion syndrome symptoms
- Health Behaviour inventory
- (and 8 more...)
|
70 |
All |
8 Years to 16 Years (Child) |
NCT03339037 |
0120-16-ASF |
TBIPED |
November 1, 2017 |
November 1, 2019 |
November 1, 2019 |
November 13, 2017 |
November 13, 2017 |
|
- Assaf-Harofeh Medical Center
Zerifin, Israel
|
|
| 85 |
NCT03678077 |
Recruiting
New |
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury |
- Mild Traumatic Brain Injury
- Concussion, Mild
- Academic Achievement
- (and 7 more...)
|
- Other: Mild traumatic brain injury
|
Observational
|
|
- University of Copenhagen
- Rigshospitalet, Denmark
- Sygekassernes Helsefond
- Aase and Ejnar Danielsens Foundation
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Cohabitation status
- Education
- Income
- Socioeconomic status
|
40000 |
All |
18 Years to 60 Years (Adult) |
NCT03678077 |
mTBI-HJG-2018 |
|
September 20, 2018 |
July 1, 2019 |
July 1, 2019 |
September 19, 2018 |
September 19, 2018 |
|
- Department of Psychology, University of Copenhagen
Copenhagen, DK, Denmark
|
|
| 86 |
NCT02819778 |
Not yet recruiting |
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury |
- Craniocerebral Trauma
- Pediatrics
|
- Procedure: usual care
- Procedure: S100B
|
Interventional
|
Phase 3 |
- University Hospital, Clermont-Ferrand
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- utility of serum S100B measurement in the management of pediatric mTBI
- utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
- utility of serum S100B measurement with respect to reduction in the duration of hospitalization
- (and 5 more...)
|
4000 |
All |
up to 16 Years (Child) |
NCT02819778 |
CHU-0269
2016-A00195-46 |
PROS100B |
July 2016 |
August 2018 |
November 2018 |
June 30, 2016 |
July 1, 2016 |
|
- Hospices Civils de LYON
Bron, France - CHU Clermont-Ferrand
Clermont-Ferrand, France - Limoges Teaching hospital
Limoges, France - (and 5 more...)
|
|
| 87 |
NCT03523507 |
Not yet recruiting |
fMRI-neuronavigated rTMS Treatment for Symptoms of Depression Associated With Concussive TBI in the Military Population |
- Traumatic Brain Injury
- Concussion, Mild
- Depressive Symptoms
|
- Device: Active: rTMS
- Device: Sham: rTMS
|
Interventional
|
Not Applicable |
- Uniformed Services University of the Health Sciences
- Center for Neuroscience and Regenerative Medicine (CNRM)
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Improvement in Depressive Symptoms
- Changes in Cognitive Function
- Changes in TBI-related Symptoms
- (and 5 more...)
|
90 |
All |
18 Years to 64 Years (Adult) |
NCT03523507 |
898115 |
|
August 1, 2018 |
May 1, 2020 |
May 1, 2020 |
May 14, 2018 |
May 31, 2018 |
|
- Walter Reed National Military Medical Center
Bethesda, Maryland, United States - Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States
|
|
| 88 |
NCT03218332 |
Recruiting |
Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study |
- Chronic Traumatic Encephalopathy
|
- Diagnostic Test: Biomarkers for detecting possible CTE invivo
|
Observational
|
|
- University Health Network, Toronto
- The Weston A. Price Foundation
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Biomarkers for possible CTE
|
150 |
Male |
25 Years to 85 Years (Adult, Older Adult) |
NCT03218332 |
11-0088-B |
|
July 4, 2011 |
December 30, 2017 |
December 30, 2020 |
July 14, 2017 |
July 14, 2017 |
|
- Canadian Concussion Centre, Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
|
|
| 89 |
NCT02990793 |
Recruiting |
Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Persistent Post-Concussive Symptoms (PPCS) |
- Postconcussive Symptoms
- Traumatic Brain INjury
- PostTraumatic Stress Disorder
|
- Device: Active MeRT Treatment
- Device: Sham MeRT Treatment
|
Interventional
|
Not Applicable |
- Newport Brain Research Laboratory
- Uniformed Services University of the Health Sciences
- U.S. Special Operations Command
- (and 2 more...)
|
Industry / U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in PPCS
- PTSD Symptom Reduction
|
150 |
All |
18 Years to 55 Years (Adult) |
NCT02990793 |
MeRT-TBI-005 |
MeRT-TBI-005 |
July 24, 2017 |
July 2018 |
August 2018 |
December 13, 2016 |
November 8, 2017 |
|
- Naval Special Warfare
San Diego, California, United States - MacDill Air Force Base
Macdill Air Force Base, Florida, United States
|
|
| 90 |
NCT03230656 |
Recruiting |
Cognitive-Communication Screening and Early Therapy for Adults With Mild TBI |
- Concussion
- Mild Traumatic Brain Injury
- Cognitive Communication Disorder
|
- Other: Early cognitive-communication therapy
|
Interventional
|
Not Applicable |
- Northern Arizona University
- National Institute on Deafness and Other Communication Disorders (NIDCD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- SCAN-A Competing Sentences Subtest
- FAVRES Sequencing subtest
- WJ-III Tests of Cognitive Abilities Matching subtest
- (and 2 more...)
|
300 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03230656 |
1003140
1R15DC015338-01A1 |
|
January 2017 |
December 2019 |
December 2020 |
July 26, 2017 |
August 21, 2018 |
|
- Northern Arizona University
Flagstaff, Arizona, United States
|
|
| 91 |
NCT02475044 |
Recruiting |
Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits |
|
- Behavioral: Cognitive-Behavioral Therapy
|
Interventional
|
Not Applicable |
- Rabin Medical Center
- The Israeli insurance companies organization
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
- Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
- Change from Baseline in the Childrens Depression Inventory at Treatment Completion
- (and 2 more...)
|
200 |
All |
6 Years to 17 Years (Child) |
NCT02475044 |
0439-14 |
|
June 2015 |
June 2018 |
June 2018 |
June 18, 2015 |
October 11, 2016 |
|
- Schneider Childrens' Medical Center of Israel
Petach Tikva, Israel
|
|
| 92 |
NCT03213730 |
Recruiting |
Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery |
- Brain Concussion
- Post-Concussion Symptoms
- Concussion
|
- Other: 3D-MOT Neurotracker
- Other: Visual Attention Intervention
|
Interventional
|
Not Applicable |
- McGill University Health Center
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Post Concussion Symptom Inventory
|
90 |
All |
6 Years to 17 Years (Child) |
NCT03213730 |
13-146-PED |
|
January 10, 2017 |
April 30, 2019 |
July 30, 2019 |
July 11, 2017 |
July 11, 2017 |
|
- Montreal Children's Hospital, MUHC
Montreal, Quebec, Canada
|
|
| 93 |
NCT03600324 |
Not yet recruiting |
Randomized Controlled Trial for Vestibular Treatment in Concussion |
- Vestibular Disorder
- Mild Traumatic Brain Injury
|
|
Interventional
|
Not Applicable |
- University of Pittsburgh
- United States Department of Defense
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Dizziness Handicap Inventory
- Patient Global Impression of Change (PGIC)
- Neurobehavioral Symptom Inventory (NSI)
- (and 11 more...)
|
125 |
All |
18 Years to 40 Years (Adult) |
NCT03600324 |
PRO18070243
PT170144 |
|
October 2018 |
December 2022 |
December 2022 |
July 25, 2018 |
July 27, 2018 |
|
|
|
| 94 |
NCT02374918 |
Recruiting |
Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury |
- Concussion, Mild
- Post-Concussion Symptoms
- Sleep Problems
|
- Device: mTBI wavelength-1 bright light
- Device: mTBI wavelength-2 bright light
- Device: HC wavelength-1 bright light
- Device: HC wavelength-2 bright light
|
Interventional
|
Not Applicable |
- University of Arizona
- U.S. Army Medical Research Acquisition Activity
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Sleep Quality ( self-report measure: Pittsburgh Sleep Quality Index, and an objective measure: Actigraphy will be used to assess sleep quality)
- Neural activation during functional magnetic resonance imaging (fMRI) executive function task (Multi-Source Interference Task (MSIT)
- Performance on neuropsychological assessment (Automated Neuropsychological Assessment Metrics, Repeatable Battery for the Assessment of Neuropsychological Status, and Psychomotor Vigilance Task will be used to assess this.)
- (and 2 more...)
|
69 |
All |
18 Years to 50 Years (Adult) |
NCT02374918 |
1404301151 |
|
April 2015 |
December 2018 |
December 2018 |
March 2, 2015 |
July 26, 2018 |
|
- University of Arizona
Tucson, Arizona, United States
|
|
| 95 |
NCT03649958 |
Recruiting
New |
Neurotechnology Following Traumatic Brain Injury |
- Post-Concussion Symptoms
- Insomnia
- Pain, Chronic
- Depressive Symptoms
|
|
Interventional
|
Not Applicable |
- Brain State Technologies, LLC
- Uniformed Services University of the Health Sciences
- Womack Army Medical Center
|
Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Neurobehavioral Symptom Inventory (NSI)
- PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE
- PITTSBURGH SLEEP QUALITY INDEX
- (and 4 more...)
|
106 |
All |
18 Years and older (Adult, Older Adult) |
NCT03649958 |
MED-83-8754
W81XWH1720057 |
Cereset |
August 28, 2018 |
March 2020 |
September 2020 |
August 28, 2018 |
August 29, 2018 |
|
- Uniformed Services University
Bethesda, Maryland, United States - Womack Army Medical Center
Fort Bragg, North Carolina, United States
|
|
| 96 |
NCT02690584 |
Recruiting |
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury |
- Brain Injuries
- Post-Concussive Symptom
- Post-Concussive Syndrome
|
- Behavioral: Metacognitive therapy
|
Interventional
|
Not Applicable |
- Norwegian University of Science and Technology
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire
- Conners CPT-III
- D-KEFS Trail Making Test
- (and 16 more...)
|
20 |
All |
16 Years to 65 Years (Child, Adult, Older Adult) |
NCT02690584 |
2015/1456 |
|
March 2016 |
April 2023 |
April 2023 |
February 24, 2016 |
October 24, 2017 |
|
- Psykologisk Institutt, Dragvoll
Trondheim, Norway
|
|
| 97 |
NCT03123224 |
Recruiting |
The COACH Project: Combined Online Assistance for Caregiver Health |
- Traumas, Brain
- Alzheimer Disease
- Dementia
- (and 3 more...)
|
- Behavioral: Combined Aerobic and Resistance Exercise + Caregiver Skills Training
- Behavioral: Stretching Balance and Flexibility + Caregiver Skills Training
|
Interventional
|
Not Applicable |
- Palo Alto Veterans Institute for Research
- United States Department of Defense
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Caregiver Burden using Zarit Burden Inventory
|
200 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT03123224 |
FAI0003AGG
W81XWH-15-1-0246 |
COACH |
August 2015 |
July 2018 |
July 2018 |
April 21, 2017 |
January 18, 2018 |
|
- VA Palo Alto Health Care System
Palo Alto, California, United States
|
|
| 98 |
NCT03478059 |
Recruiting |
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI |
- Brain Injury Traumatic Mild
- Concussion, Brain
|
- Behavioral: Cognitive and Motor Dual-task Intervention
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in peak velocity turns during Instrumented Stand and Walk Test
- Change in peak turning velocity during walking a custom turning course
- Change in peak turning velocity during running an agility course
- (and 11 more...)
|
24 |
All |
18 Years to 50 Years (Adult) |
NCT03478059 |
CKMW-1701 |
|
October 31, 2017 |
October 31, 2018 |
October 31, 2018 |
March 27, 2018 |
March 29, 2018 |
|
- Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
|
|
| 99 |
NCT03098459 |
Recruiting |
Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study |
- Delirium
- Cognitive Impairment
- Alzheimer; Early Onset
- (and 5 more...)
|
- Other: Non-interventional observational prospective cohort study
|
Observational
|
|
- Vanderbilt University Medical Center
- National Institutes of Health (NIH)
- National Institute of General Medical Sciences (NIGMS)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- LTCI (Long-term Cognitive Impairment) as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
|
900 |
Male |
18 Years and older (Adult, Older Adult) |
NCT03098459 |
171335
R01GM120484 |
INSIGHT-ICU |
November 2, 2017 |
November 2021 |
November 2021 |
March 31, 2017 |
March 29, 2018 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
|
| 100 |
NCT03244475 |
Recruiting |
Transcranial Electrical Stimulation for mTBI |
- Mild Traumatic Brain Injury (mTBI)
- Post-traumatic Stress Disorder
|
- Device: IASIS Micro Current Neurofeedback
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
- San Diego Veterans Healthcare System
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Change in Number of Abnormal MEG Slow-Waves
- Combat and Post-battle Experiences Scales of the Deployed Risk and Resilience Inventory 2
- Ohio State University Traumatic Brain injury Identification method (OSU TBI-ID)
- (and 18 more...)
|
175 |
All |
18 Years to 60 Years (Adult) |
NCT03244475 |
B1988-I
RX001988-01A1 |
TES for mTBI |
February 1, 2017 |
September 30, 2021 |
September 30, 2021 |
August 9, 2017 |
July 13, 2018 |
|
- VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
|
|
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