| 1 |
NCT02189525 |
Recruiting |
Evaluation of Mild TBI in Collegiate Athletes |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussion
- Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion
- Correlation of serum biomarker levels and neuroimaging results to standard clinical measures of concussion in the acute phase of injury and at the completion of collegiate athletic participation
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT02189525 |
HHC-001 |
AWARE |
August 2014 |
December 2017 |
|
July 14, 2014 |
July 20, 2016 |
|
- University of Florida
Gainesville, Florida, United States
|
| 2 |
NCT02861547 |
Recruiting |
Development and Validation of a Prognostic Score for Early Death in Head Injury Patients. |
|
|
Observational |
|
- Centre Hospitalier Universitaire Dijon
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
355 |
All |
15 Years and older (Child, Adult, Senior) |
NCT02861547 |
MIREK 2015 |
SCORE TC |
May 2015 |
May 2017 |
|
August 10, 2016 |
August 10, 2016 |
|
- CHU Dijon Bourgogne
Dijon, France
|
| 3 |
NCT02855034 |
Recruiting |
Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children |
|
|
Interventional |
Not Applicable |
- University Hospital, Montpellier
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Copeptine dosage
- Protein S100B dosage
|
220 |
All |
3 Months to 15 Years (Child) |
NCT02855034 |
UF 9546
2015-A00553-46 |
TCOP100 |
May 2016 |
May 2018 |
May 2018 |
August 4, 2016 |
August 4, 2016 |
|
- Montpellier University Hospital
Montpellier, 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, Senior) |
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, Senior) |
NCT03280485 |
no number |
|
September 10, 2017 |
December 31, 2020 |
December 31, 2021 |
September 12, 2017 |
September 25, 2017 |
|
- Halland Hospital Halmstad
Halmstad, Sweden
|
| 8 |
NCT03249818 |
Recruiting |
HITT Device Pilot Testing for Traumatic Brain Injury |
- Brain Injuries, Traumatic
|
|
Interventional |
Not Applicable |
- Rebiscan, Inc.
- University of Pennsylvania
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
|
10 |
All |
18 Years to 40 Years (Adult) |
NCT03249818 |
rebiscan-004 |
|
August 22, 2017 |
October 2017 |
October 2017 |
August 15, 2017 |
September 28, 2017 |
|
- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 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 |
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, Senior) |
NCT01402882 |
ISRCTN15088122 |
CRASH-3 |
September 2011 |
January 2019 |
April 2020 |
July 26, 2011 |
March 7, 2018 |
|
- High Technology Medical Center, University Clinic
Tblisi, Georgia
|
| 11 |
NCT03482206 |
Not yet recruiting
New |
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, Senior) |
NCT03482206 |
HUM00137659 |
|
June 1, 2018 |
December 31, 2018 |
December 31, 2019 |
March 29, 2018 |
April 18, 2018 |
|
|
| 12 |
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, Senior) |
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
|
| 13 |
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
|
| 14 |
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, Senior) |
NCT02215187 |
#000435754
H133G110275 |
|
July 2013 |
September 2018 |
September 2018 |
August 13, 2014 |
December 15, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States
|
| 15 |
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
|
| 16 |
NCT02849002 |
Recruiting |
Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM) |
- 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
- Average number of days the signal pattern seen within BrainPulse recordings from confirmed concussed subjects from the initial recording persist over the course of the 21 day follow up period.
|
300 |
All |
13 Years and older (Child, Adult, Senior) |
NCT02849002 |
JMC-1601-P01 |
|
July 2016 |
June 2017 |
|
July 29, 2016 |
August 31, 2016 |
|
- Konkussion Inc.
Woodbridge, Ontario, Canada
|
| 17 |
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, Senior) |
NCT02924649 |
H-16030775 |
|
January 2017 |
May 2019 |
September 2019 |
October 5, 2016 |
November 21, 2017 |
|
- Rigshospitalet,
Copenhagen, Denmark
|
| 18 |
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, Senior) |
NCT02639923 |
Wolf-7 |
mRNA |
January 2016 |
March 2017 |
July 2017 |
December 28, 2015 |
March 27, 2017 |
|
- Medical University of Vienna
Vienna, Austria
|
| 19 |
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 |
March 1, 2018 |
|
- Naval Medical Center San Diego
San Diego, California, United States
|
| 20 |
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, Senior) |
NCT01132937 |
100122
10-N-0122 |
|
July 1, 2010 |
|
|
May 28, 2010 |
October 27, 2017 |
|
- Washington Hospital Center
Washington, D.C., District of Columbia, United States - Suburban Hospital
Bethesda, Maryland, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 21 |
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, 2018 |
March 1, 2020 |
June 23, 2014 |
April 4, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 22 |
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, Senior) |
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
|
| 23 |
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) |
NCT02993549 |
A094233 |
monTBI |
October 2017 |
January 2022 |
October 2022 |
December 15, 2016 |
May 8, 2017 |
|
- Cambridge University Hospital NHS Trust
Cambridge, Cambridgeshire, United Kingdom
|
| 24 |
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, Senior) |
NCT03191357 |
MED-83-2622 |
MRP |
March 2014 |
July 2019 |
July 2020 |
June 19, 2017 |
June 19, 2017 |
|
- Uniformed Services University of Health Sciences (USUHS)
Bethesda, Maryland, United States
|
| 25 |
NCT02754063 |
Recruiting |
Impact of Early Optimization of Brain Oxygenation on the Volume of Cerebral Lesions 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
|
- Volume of cerebral lesions with abnormal mean diffusivity values using diffusion tensor imaging
- Extended Glasgow Outcome Scale
- Functional Independence Measure scale
- (and 4 more...)
|
300 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02754063 |
38RC14.039 |
OXY-TC |
June 2016 |
May 2018 |
May 2019 |
April 28, 2016 |
March 29, 2017 |
|
- General Hospital of Annecy
Annecy, France - University Hospital of Bordeaux
Bordeaux, France - University Hospital of Clermont-Ferrand
Clermont-Ferrand, France - (and 18 more...)
|
| 26 |
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
|
| 27 |
NCT02832908 |
Recruiting |
Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma |
|
- Other: Change from semi-seated position to supine
|
Interventional |
Not Applicable |
- University Hospital, Montpellier
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- ASSESSMENT OF THE CEREBRAL OXYGENATION
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT02832908 |
9413 |
PULSATILITY |
December 2014 |
December 2016 |
December 2016 |
July 14, 2016 |
July 14, 2016 |
|
- Hôpital Lapeyronie - Département Anesthésie Réanimation A
Montpellier, France
|
| 28 |
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 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 29 |
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) |
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
|
| 30 |
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
|
| 31 |
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) |
NCT03035838 |
212176 |
NK1 |
September 2017 |
December 2018 |
April 2019 |
January 30, 2017 |
May 3, 2017 |
|
|
| 32 |
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, Senior) |
NCT02504866 |
150164
15-CC-0164 |
|
December 15, 2016 |
December 31, 2018 |
December 30, 2019 |
July 22, 2015 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 33 |
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, Senior) |
NCT02233413 |
2013P000430
W81XWH-13-2-0067 CDMRP |
LLLT for TBI |
June 2014 |
December 2017 |
December 2018 |
September 8, 2014 |
July 21, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 34 |
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, Senior) |
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
|
| 35 |
NCT03081169 |
Recruiting |
Timing of VTE Prophylaxis in TBI |
- TBI (Traumatic Brain Injury)
- VTE (Venous Thromboembolism)
|
- Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe
- Drug: Heparin
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- VTE
- Bleeding complications
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03081169 |
209199 |
|
April 3, 2017 |
February 15, 2019 |
February 15, 2019 |
March 16, 2017 |
April 28, 2017 |
|
- Loyola University Medical Center
Maywood, Illinois, 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, Senior) |
NCT03306563 |
T213/2017 |
|
December 7, 2017 |
December 2018 |
December 2018 |
October 11, 2017 |
December 8, 2017 |
|
- Turku University Hospital (Tyks)
Turku, Finland
|
| 37 |
NCT02868684 |
Not yet recruiting |
Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study |
- Mild Traumatic Brain Injury
- Posttraumatic Stress Disorder
- Affective and Somatic Complaints
- Cognitive Impairments
|
|
Observational |
|
- First Affiliated Hospital Xi'an Jiaotong University
- Second Affiliated Hospital of Wenzhou Medical University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom
- Changes in post-concussive symptoms
- changes in affective complaints
- Changes in somatic complaints
|
120 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02868684 |
NSFC81571752-1 |
|
August 2016 |
August 2018 |
September 2018 |
August 16, 2016 |
August 16, 2016 |
|
|
| 38 |
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) |
NCT02988102 |
FKelmendi |
|
December 2016 |
December 2016 |
August 2017 |
December 9, 2016 |
December 9, 2016 |
|
- Fatos Kelmendi
Tirana, Kosovo Prishtina, Albania
|
| 39 |
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, Senior) |
NCT02812225 |
JMC-1502 |
|
June 2016 |
June 2017 |
September 2017 |
June 24, 2016 |
October 6, 2016 |
|
- 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
|
| 40 |
NCT03479541 |
Not yet recruiting
New |
Can Early Initiation of Rehabilitation With Wearable Sensor Technology Improve Outcomes in mTBI? |
- Mild Traumatic Brain Injury
- Balance; Distorted
- Gait, Unsteady
- (and 2 more...)
|
- Behavioral: Rehabilitation
|
Interventional |
Not Applicable |
- Oregon Health and Science University
- United States Department of Defense
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Dizziness Handicap Inventory
- Automated Neuropsychological Assessment Metrics
- Neurobehavioral Symptom Inventory
- (and 14 more...)
|
160 |
All |
18 Years to 60 Years (Adult) |
NCT03479541 |
DOD2 |
|
May 1, 2018 |
February 15, 2020 |
May 1, 2021 |
March 27, 2018 |
March 29, 2018 |
|
- Oregon Health & Science University
Portland, Oregon, United States
|
| 41 |
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, Senior) |
NCT02798601 |
U1111-1183-0891
HPTU |
EHIBE |
October 2018 |
August 2022 |
December 2022 |
June 14, 2016 |
August 10, 2017 |
|
|
| 42 |
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
|
| 43 |
NCT02424656 |
Recruiting |
Alterations in the Brain's Connectome After Severe Traumatic Brain Injury |
- Traumatic Brain Injury
- Disorders of Consciousness
|
- Procedure: MRI
- Procedure: TMS-EEG
- Procedure: FDG-PET
- Other: Clinical scales
|
Observational |
|
- Danish Research Centre for Magnetic Resonance
- University of Milan
- University of Kiel
- (and 4 more...)
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Changes in whole brain connectivity as a measure of recovery of consciousness
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02424656 |
H-4-2013-186 |
ABCinTBI |
September 2014 |
December 2017 |
December 2018 |
April 23, 2015 |
June 5, 2017 |
|
- Danish Research Centre for Magnetic Resonance
Copenhagen, Denmark
|
| 44 |
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) |
NCT02356861 |
D1768-P
1I21RX001768-01 |
|
March 1, 2016 |
March 1, 2019 |
March 1, 2019 |
February 5, 2015 |
March 19, 2018 |
|
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
|
| 45 |
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, Senior) |
NCT03266380 |
VAP |
|
January 1, 2018 |
December 1, 2019 |
December 30, 2019 |
August 30, 2017 |
September 8, 2017 |
|
|
| 46 |
NCT01339702 |
Recruiting |
The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines |
- Brain Injuries, Traumatic
- Injuries, Acute Brain
- TBI (Traumatic Brain Injury)
|
- Other: The National Prehospital TBI Management Guidelines
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Survival
- hospital length of stay
- Intensive care unit length of stay
- (and 2 more...)
|
20000 |
All |
Child, Adult, Senior |
NCT01339702 |
EPIC-NINDS-R01NS071049 |
EPIC |
September 2011 |
August 2017 |
August 2017 |
April 21, 2011 |
March 1, 2017 |
|
- Arizona Emergency Medicine Research Center
Phoenix, Arizona, United States
|
| 47 |
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 |
June 7, 2018 |
December 8, 2018 |
March 15, 2018 |
March 16, 2018 |
|
- The Citadel
Charleston, South Carolina, United States
|
| 48 |
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
|
| 49 |
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
|
| 50 |
NCT02061553 |
Recruiting |
SMS Messaging to Reduce Depression and Anxiety Following TBI |
|
- Behavioral: Intention
- Behavioral: Motivation
|
Interventional |
Not Applicable |
- Albert Einstein Healthcare Network
- U.S. Department of Education
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline on Environmental Reward Observation Scale (EROS)
- Change from baseline on Behavioral Activation for Depression Scale (BADS)
- Change from baseline on Brief Symptom Inventory-18 (BSI-18)
- (and 3 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02061553 |
TBIMS HN4473
H133A120037 |
|
June 2013 |
June 2017 |
June 2017 |
February 13, 2014 |
October 4, 2016 |
|
- Moss Rehabilitation Research Institue
Elkins Park, Pennsylvania, United States
|
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