| 1 |
NCT03401645 |
Recruiting |
Home-based Arm and Hand Exercise to Improve Upper Limb Function After Traumatic Brain Injury |
- Brain Injuries, Traumatic
|
- Other: Wrist Alarm
- Behavioral: Home-based Arm and Hand Exercise
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Wolf Motor Function Test - Functional Ability Scale (WMFT-FAS)
|
60 |
All |
20 Years to 60 Years (Adult) |
NCT03401645 |
E-974-17 |
|
July 1, 2017 |
February 2019 |
June 2019 |
January 17, 2018 |
January 17, 2018 |
|
- Kessler Foundation Research Center
West Orange, New Jersey, United States
|
|
| 2 |
NCT03169647 |
Recruiting |
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury |
- Brain Injuries, Traumatic
|
- Behavioral: Listening-based intervention
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Goodman and Kruskal gamma coefficient on MRI-based metacognitive task
|
40 |
All |
18 Years to 59 Years (Adult) |
NCT03169647 |
R-936-16 |
|
August 17, 2017 |
June 30, 2018 |
June 30, 2018 |
May 30, 2017 |
August 21, 2017 |
|
- Kessler Foundation
East Hanover, New Jersey, United States
|
|
| 3 |
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
|
|
| 4 |
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
|
|
| 5 |
NCT02698449 |
Not yet recruiting |
Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study |
|
- Procedure: transcranial direct current stimulation
- Procedure: Specific cognitive rehabilitation
- Procedure: Nonspecific cognitive rehabilitation
- (and 2 more...)
|
Interventional
|
Not Applicable |
- University Hospital, Toulouse
- Fondation de l'Avenir
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
- Intergroup differences in resting activation maps.
- Intergroup differences in diffusion measures
- (and 3 more...)
|
80 |
All |
18 Years to 60 Years (Adult) |
NCT02698449 |
14 7328 03 |
RemCog-TC |
September 2016 |
March 2019 |
March 2019 |
March 3, 2016 |
March 10, 2016 |
|
- CHU Toulouse
Toulouse, France
|
|
| 6 |
NCT02321761 |
Recruiting |
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury |
|
- Drug: Amantadine hydrochloride
|
Interventional
|
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
10 |
All |
18 Years to 50 Years (Adult) |
NCT02321761 |
15-12-LOE |
|
June 2014 |
December 1, 2018 |
December 1, 2018 |
December 22, 2014 |
August 8, 2018 |
|
- Loewenstein Rehabilitation Center
Ra'anana, Israel
|
|
| 7 |
NCT02920788 |
Recruiting |
Mild TBI Assessment & Rehabilitation |
- Brain Injuries, Traumatic
|
- Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS)
- Device: fMRI
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task
|
36 |
All |
18 Years and older (Adult, Older Adult) |
NCT02920788 |
N2300-R |
MTAR |
March 9, 2017 |
June 30, 2021 |
December 31, 2021 |
September 30, 2016 |
August 6, 2018 |
|
- San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
|
|
| 8 |
NCT03382626 |
Recruiting |
Transcranial Direct Current Stimulation and Computer-based Training for the Traumatic Brain Injury Rehabilitation |
|
- Device: anodal tDCS
- Device: Computer-assisted training
- Device: sham tDCS
|
Interventional
|
Not Applicable |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline working memory at 12 days (scale assessment)
- Change from baseline working memory at 12 days (computer-based assessment)
- Change from baseline executive function at 12 days (scale assessment)
- (and 5 more...)
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT03382626 |
71391917000000068 |
|
February 19, 2018 |
October 2018 |
October 2019 |
December 26, 2017 |
July 26, 2018 |
|
- Ambulatório de Reabilitação Cognitiva do Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil
|
|
| 9 |
NCT03110237 |
Not yet recruiting |
A Multidimensional Inpatient Balance Training Class to Improve Functional Outcomes in Rehabilitation Inpatients With ABI |
- Brain Injuries, Traumatic
- Cerebrovascular Trauma
- Acute Brain Injuries
|
- Other: Control Balance Training (BT) class
- Other: Fallproof Balance Training (BT) class
|
Interventional
|
Not Applicable |
- University of British Columbia
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Community Balance and Mobility Scale (CB & M)
- Timed Up and Go Test (TUG)
- 4 meters Gait Speed Test (GST)
- Falls Efficacy Scale (FES)
|
20 |
All |
16 Years to 69 Years (Child, Adult, Older Adult) |
NCT03110237 |
H16-02866 |
|
April 10, 2017 |
November 30, 2017 |
December 30, 2017 |
April 12, 2017 |
April 12, 2017 |
|
- GF Strong Rehabilitation Center
Vancouver, British Columbia, Canada
|
|
| 10 |
NCT02878577 |
Recruiting |
Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury |
- Traumatic Brain Injury (TBI)
|
|
Observational
|
|
- ElMindA Ltd
- Sheba Medical Center
- Tel Aviv University
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- fMRI responses to a cognitive executive task
- MRI Structural changes
- EEG responses to cognitive tasks in combination of an eye-tracking method
- (and 2 more...)
|
90 |
All |
18 Years to 60 Years (Adult) |
NCT02878577 |
ELM-37 |
TBI |
September 21, 2016 |
September 2018 |
December 2018 |
August 25, 2016 |
January 17, 2018 |
|
- The Chaim Sheba Medical Center
Tel Aviv, Israel
|
|
| 11 |
NCT02498262 |
Recruiting |
Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement |
- Autism Spectrum Disorder
- Traumatic Brain Injury
|
- Other: Virtual Reality System
|
Interventional
|
Not Applicable |
- University of South Florida
- Florida Department Of Education
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Improvement in composite score of performing the vocational tasks of shelving, cleaning, environmental awareness, loading back of a truck, money management and social skills.
|
100 |
All |
18 Years to 60 Years (Adult) |
NCT02498262 |
Ame2_Pro00013008 |
VR4VR |
June 2015 |
December 2018 |
December 2018 |
July 15, 2015 |
September 21, 2018 |
|
- Rehabilitation Robotics & Prosthetics Testbed (RRT) Laboratory on the campus of the University of South Florida
Tampa, Florida, United States
|
|
| 12 |
NCT03402035 |
Recruiting |
Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2) |
- Hemorrhagic Shock
- Traumatic Brain Injury
|
|
Observational
|
|
- University of Pittsburgh
- United States Department of Defense
|
Other / U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- 4 hour mortality
- 24 hour mortality
- 24 hour blood and blood component transfusion requirements
- (and 2 more...)
|
1050 |
All |
15 Years to 90 Years (Child, Adult, Older Adult) |
NCT03402035 |
PRO17090104 |
SWAT |
May 1, 2018 |
February 1, 2022 |
August 2022 |
January 17, 2018 |
May 15, 2018 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
|
| 13 |
NCT02589509 |
Recruiting |
Cognitive Rehabilitation and Brain Activity of Attention Control in TBI |
- Brain Injuries, Traumatic
|
- Behavioral: Direct-attention training using web-based BrainHQ
- Behavioral: Goal Management Training (GMT)
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Timed Instrumental Activities of Daily Living (TIADL)
- Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
- Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
- (and 14 more...)
|
36 |
All |
21 Years to 55 Years (Adult) |
NCT02589509 |
N1920-P
I21RX001920-01A1 |
|
December 1, 2015 |
October 31, 2018 |
November 30, 2018 |
October 28, 2015 |
August 31, 2018 |
|
- North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
|
|
| 14 |
NCT03513133 |
Recruiting |
Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC |
- Traumatic Brain Injury
- Cognitive Impairment
|
- Behavioral: working memory training
|
Interventional
|
Not Applicable |
- Centre d'Investigation Clinique et Technologique 805
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- working memory questionnaire
- working memory testing
- neuro-imaging changes
|
20 |
All |
18 Years to 55 Years (Adult) |
NCT03513133 |
2016-A00678-43 |
Plastim-MDTC |
July 1, 2017 |
July 1, 2019 |
December 31, 2019 |
May 1, 2018 |
May 3, 2018 |
|
- APHP Hôpital Raymond Poincaré
Garches, Ile De France, France
|
|
| 15 |
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 |
October 5, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 16 |
NCT03050801 |
Recruiting |
Functional Connectivity as a Biomarker of rTMS |
|
|
Interventional
|
Phase 1
Phase 2 |
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Functional connectivity
- Memory tests
|
123 |
All |
18 Years to 50 Years (Adult) |
NCT03050801 |
170055
17-N-0055 |
|
March 24, 2017 |
December 31, 2018 |
December 31, 2018 |
February 13, 2017 |
September 12, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
|
| 17 |
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
|
|
| 18 |
NCT03225768 |
Recruiting |
Guided Training for People With Cognitive Impairment |
- TBI (Traumatic Brain Injury)
- Stroke
- Cognitive Impairment
|
- Behavioral: Guided Training
|
Interventional
|
Not Applicable |
- Taipei Medical University WanFang Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
- Canadian Occupational Performance Measure (COPM)
- Activities
- Cognitive functioning
|
60 |
All |
20 Years and older (Adult, Older Adult) |
NCT03225768 |
N201704046 |
GTPCI |
September 1, 2017 |
March 18, 2019 |
May 18, 2019 |
July 21, 2017 |
August 7, 2018 |
|
- WanFang Hospital
New Taipei City, Taiwan
|
|
| 19 |
NCT03704116 |
Recruiting
New |
Executive Function Training Intervention for Chronic Traumatic Brain Injury |
|
|
Interventional
|
Not Applicable |
- The University of Texas at Dallas
- Applied Research Associates, Inc
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Virtual Multiple Errands Test
- Resting-State functional Magnetic Resonance Imaging (fMRI)
- Task-based functional Magnetic Resonance Imaging (fMRI)
- (and 2 more...)
|
100 |
All |
19 Years to 55 Years (Adult) |
NCT03704116 |
UTDallas |
|
July 16, 2018 |
May 31, 2020 |
June 30, 2020 |
October 12, 2018 |
October 16, 2018 |
|
- The University of Texas at Dallas Center for BrainHealth
Dallas, Texas, United States
|
|
| 20 |
NCT03373331 |
Recruiting |
Treating Emotional Processing Impairments in Individuals With TBI |
|
- Behavioral: Emotional Processing Training
- Behavioral: Placebo Control Exercises
|
Interventional
|
Not Applicable |
- Kessler Foundation
- New Jersey Commission on Brain Injury Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Emotional Processing
- Emotional Function
- Quality of Life
|
50 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03373331 |
R-875-15 |
|
September 2015 |
May 2018 |
May 2018 |
December 14, 2017 |
December 14, 2017 |
|
- Kessler Foundation
East Hanover, New Jersey, United States
|
|
| 21 |
NCT03479970 |
Recruiting |
Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury |
|
- Other: GNPT+ Social Cognition
- Other: GNPT
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- International Affect Picture System (IAPS)
- Pictures of facial Affect (POFA)
- The Moving Shapes Paradigm
- (and 14 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03479970 |
2017257 |
SOCCER |
January 2, 2018 |
January 2, 2021 |
January 2, 2022 |
March 27, 2018 |
April 5, 2018 |
|
- Hospital de Neurorehabilitació Institut Guttmann
Badalona, Barcelona, Spain
|
|
| 22 |
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
|
|
| 23 |
NCT02647996 |
Recruiting |
Functional Connectivity Measurement After Severe Traumatic Brain Injury |
- Disorder of Consciousness
|
- Procedure: MRI: functional (resting state) and structural (DTI)
|
Observational
|
|
- University Hospital, Grenoble
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- cortical functional connectivity
- consciousness level measured with Coma recovery scale -revised (CRS-R)
- cortical functional connectivity change
- (and 2 more...)
|
34 |
All |
18 Years and older (Adult, Older Adult) |
NCT02647996 |
2014-A01873-44 |
Connectivite |
March 2015 |
March 2018 |
May 2018 |
January 6, 2016 |
April 28, 2017 |
|
- Grenoble University Hospital
Grenoble, France
|
|
| 24 |
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
|
|
| 25 |
NCT03611062 |
Recruiting |
VR-based EF Rehabilitation for Pediatric TBI |
|
- Behavioral: VR Executive Functions Training
- Behavioral: VR Placebo Game
|
Interventional
|
Not Applicable |
- Nationwide Children's Hospital
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Other
|
- Incidence of Simulator Sickness [Feasibility and Safety]
- Incidence of Physical Fatigability [Feasibility and Safety]
- Incidence of Perceived Virtual Reality Experience [Feasibility]
- (and 9 more...)
|
30 |
All |
7 Years to 17 Years (Child) |
NCT03611062 |
IRB18-00472 |
|
August 15, 2018 |
June 30, 2020 |
June 30, 2020 |
August 2, 2018 |
September 18, 2018 |
|
- Nationwide Children's Hospital
Columbus, Ohio, United States
|
|
| 26 |
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
|
|
| 27 |
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
|
|
| 28 |
NCT02712996 |
Recruiting |
Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children |
- Traumatic Brain Injury
- Attention Deficit Disorder
|
- Drug: Lisdexamfetamine
- Drug: Placebo
|
Interventional
|
Phase 4 |
- Vanderbilt University
- Shire
- Vanderbilt University Medical Center
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring preservations on the Conners Continuous Performance Task (CPT-II).
- Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring Hit Reaction Time (RT) Block Change on the Conners Continuous Performance Task (CPT-II).
- Assessing sustained attention and response inhibition in children using Vyvanse versus Placebo by measuring RT Inter-Stimulus Interval (ISI) on the Conners Continuous Performance Task (CPT-II).
- (and 4 more...)
|
30 |
All |
6 Years to 16 Years (Child) |
NCT02712996 |
TBI 56592 |
TBIC |
February 6, 2017 |
November 10, 2019 |
November 10, 2019 |
March 18, 2016 |
February 28, 2018 |
|
- Vanderbilt Medical Center
Nashville, Tennessee, United States
|
|
| 29 |
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
|
|
| 30 |
NCT02310633 |
Recruiting |
Developing Process-Specific Verbal Memory Interventions for Veterans With Tramatic Brain Injury (TBI) |
|
- Behavioral: Memory Strategy Training
- Behavioral: Errorless Learning
- Behavioral: Retrieval Practice
|
Interventional
|
Phase 1
Phase 2 |
- VA Office of Research and Development
- University of Florida
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in performance on paired-associate learning of words and face-name pairs
- Change in functional brain connectivity within memory-relevant brain networks
- Mayo-Portland Adaptability Inventory (MPAI-4)
- (and 6 more...)
|
20 |
All |
25 Years to 65 Years (Adult, Older Adult) |
NCT02310633 |
N1730-P
1I21RX001730-01 |
DPSVM |
January 5, 2015 |
December 22, 2017 |
December 29, 2017 |
December 8, 2014 |
October 9, 2017 |
|
- North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
|
|
| 31 |
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
|
|
| 32 |
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
|
|
| 33 |
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 |
|
|
|
| 34 |
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
|
|
| 35 |
NCT03201887 |
Not yet recruiting |
Detecting Malingering Detection Using Eye Movements and Response Time (MDER) |
- Traumatic Brain Damage
- Chronic Pain
|
- Behavioral: Sub-optimal effort
- Behavioral: optimal effort
|
Interventional
|
Not Applicable |
- Loewenstein Hospital
- Ariel University
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Basic Science
|
|
120 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03201887 |
Tasmc16ys0ctil |
|
July 1, 2017 |
January 1, 2019 |
January 1, 2019 |
June 28, 2017 |
June 28, 2017 |
|
|
|
| 36 |
NCT03268304 |
Not yet recruiting |
Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments |
- Stroke
- Parkinson Disease
- Traumatic Brain Injury
- Guillain-Barre Syndrome
|
- Other: VR-based training including AO and MI
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- cARAT
- dARAT
- SUS
- (and 4 more...)
|
75 |
All |
18 Years and older (Adult, Older Adult) |
NCT03268304 |
KAYO |
|
November 2017 |
June 2018 |
August 2018 |
August 31, 2017 |
September 26, 2017 |
|
|
|
| 37 |
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
|
|
| 38 |
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
|
|
| 39 |
NCT02719964 |
Recruiting |
Rehabilitation of Visual Attention Following mTBI |
|
- Other: Visual Attention Program (UCR Games)
- Other: Speech Pathologist-Directed Therapy
- Other: General Cognitive Rehabilitation Games (Lumosity)
|
Interventional
|
Not Applicable |
- United States Naval Medical Center, San Diego
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Post-Concussion Cognitive Symptoms
- Severity of Post-Concussive Symptoms
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT02719964 |
NMCSD.2015.0049 |
|
May 2016 |
January 2019 |
January 2019 |
March 25, 2016 |
September 29, 2017 |
|
- Naval Medical Center San Diego
San Diego, California, United States
|
|
| 40 |
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 |
|
|
|
| 41 |
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
|
|
| 42 |
NCT03696381 |
Recruiting
New |
Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury |
- Traumatic Brain Injury
- Cognitive Impairment
|
- Other: Real tRNS
- Other: Sham tRNS
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Conners Continuous Performance Test (CPT-II)
- Digit Span Forward from the Wechsler Adult Intelligence Scale
- Digit Span Backward from the Wechsler Adult Intelligence Scale
- (and 7 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03696381 |
2018-281 |
TRUST |
October 2018 |
September 2019 |
December 2020 |
October 4, 2018 |
October 4, 2018 |
|
- Institut Guttmann
Badalona, Barcelona, Spain
|
|
| 43 |
NCT03490110 |
Recruiting |
Brain Markers of Improvements in Cognitive Functioning |
- TBI (Traumatic Brain Injury)
- Brain Injuries
- Stress
- (and 2 more...)
|
- Behavioral: State regulation skill training
- Other: Treatment-as-usual
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
- VA Northern California Health Care System
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Change in Event-Related Potential (ERP) related to memory retrieval (measured in �V)
- Event-Related Potential (ERP) related to memory retrieval (measured in �V)
- Composite score of attention and executive functioning from a neurocognitive test battery
- Network modularity from EEG
|
40 |
All |
21 Years to 55 Years (Adult) |
NCT03490110 |
N2240-P
16-12-00774 |
|
October 1, 2017 |
December 1, 2018 |
December 31, 2018 |
April 6, 2018 |
September 27, 2018 |
|
- VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
|
|
| 44 |
NCT03086031 |
Not yet recruiting |
Manual-Based Vocational Rehabilitation Program for Patients With Acquired Brain Injury |
|
- Behavioral: Program -based vocational rehabilitation intervention
- Behavioral: Conventional vocational rehabilitation (controls)
|
Interventional
|
Not Applicable |
- Brain Injury Center BOMI, Roskilde, Denmark
- University of Copenhagen
- Rigshospitalet, Denmark
- Hospital de Cruces
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Increased work/study rate at 6-month follow-up
- Proficiency on functional task and functional status
- Health related quality of life
- (and 8 more...)
|
84 |
All |
16 Years to 60 Years (Child, Adult) |
NCT03086031 |
2016-41-4950 |
|
August 2017 |
December 2019 |
December 2019 |
March 22, 2017 |
July 13, 2017 |
|
|
|
| 45 |
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
|
|
| 46 |
NCT03655782 |
Not yet recruiting |
Improvements in Cognitive Skills From Traumatic Brain Injury Using Dynamic Visual Attention Training |
- TBI (Traumatic Brain Injury)
|
- Behavioral: PATH neurotraining
|
Interventional
|
Not Applicable |
- Perception Dynamics Institute
- University of California, San Diego
- University of South Alabama
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Visual Working Memory
- Change in Attention
- Change in Cognitive Flexibility
- (and 6 more...)
|
144 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03655782 |
PerceptionDI |
|
April 1, 2019 |
September 30, 2020 |
September 30, 2023 |
August 31, 2018 |
September 5, 2018 |
|
- University of California at San Diego
San Diego, California, United States - Perception Dynamics Institute
Solana Beach, California, United States
|
|
| 47 |
NCT00857207 |
Recruiting |
Metacognitive Training to Enhance Strategy Use in Blast-Related TBI |
- Brain Concussion
- Blast Injuries
|
- Behavioral: Goal Management Training
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
54 |
All |
18 Years to 55 Years (Adult) |
NCT00857207 |
B0902-W |
|
October 1, 2013 |
September 28, 2018 |
September 28, 2018 |
March 6, 2009 |
April 23, 2018 |
|
- North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
|
|
| 48 |
NCT02059941 |
Recruiting |
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines |
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The Galveston Orientation and Amnesia Test (GOAT
- Color Trails Test
- Spanish verbal learning test
- (and 6 more...)
|
780 |
All |
13 Years and older (Child, Adult, Older Adult) |
NCT02059941 |
44679 |
|
September 30, 2012 |
July 31, 2017 |
July 31, 2019 |
February 11, 2014 |
May 30, 2017 |
|
- Hospital Viedma
Cochabamba, Bolivia - Hospital Japones
Santa Cruz de la Sierra, Bolivia - Hospital San Juan de Dios
Santa Cruz de la Sierra, Bolivia - (and 10 more...)
|
|
| 49 |
NCT03674398 |
Not yet recruiting |
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 25, 2018 |
|
|
|
| 50 |
NCT02227056 |
Recruiting |
Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population |
|
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Measure time (in minutes and seconds) and the amount of assistance needed (number of times each participant needed assistance) to complete the different tasks.
|
40 |
All |
4 Years to 18 Years (Child, Adult) |
NCT02227056 |
loe130007ctil |
|
January 2014 |
December 2017 |
December 2017 |
August 27, 2014 |
October 31, 2017 |
|
- Loewenstein Rehabilitation Hospital Center
Raanana, Israel
|
|
| 51 |
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
|
|
| 52 |
NCT03211884 |
Recruiting |
Evidence-Based Mental Health Services for Distressed Post-9/11 Military Family Caregivers |
- Military Family
- Brain Injuries, Traumatic
|
- Other: Problem-solving therapy
|
Interventional
|
Not Applicable |
- Duquesne University
- United States Department of Defense
- Chatham University
- University of Pittsburgh
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Mental health quality of life (QOL)
- Change in Depression symptom levels
- Change in Perceived caregiver burden
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT03211884 |
W81XWH-16-1-0690 |
|
July 13, 2017 |
February 6, 2020 |
November 30, 2020 |
July 7, 2017 |
October 10, 2018 |
|
- Duquesne University
Pittsburgh, Pennsylvania, United States
|
|
| 53 |
NCT03314584 |
Recruiting |
Managing MTBI-related Headaches With rTMS |
- Traumatic Brain Injury (TBI)
|
- Device: Transcranial Magnetic Stimulation
- Device: Sham Transcranial Magnetic Stimulation
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Reduce the intensity, frequency and duration of MTBI-headaches
- Change from Baseline to Post-Treatment Quality of Life scores
- Change from Baseline to Post-Treatment Depression scores
- (and 6 more...)
|
128 |
All |
18 Years to 50 Years (Adult) |
NCT03314584 |
B2506-I
H170053 |
|
January 1, 2018 |
September 30, 2020 |
September 30, 2022 |
October 19, 2017 |
June 20, 2018 |
|
- VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
|
|
| 54 |
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
|
|
| 55 |
NCT02317107 |
Recruiting |
Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion |
|
|
Observational
|
|
- Boston Children’s Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Dynamic Balance Control
- Temporal/Distance Gait Measurements
- Vestibular-Ocular Motor Screen
- Weekly physical and cognitive activity scores
|
60 |
All |
12 Years to 40 Years (Child, Adult) |
NCT02317107 |
IRB-P00016317 |
|
June 30, 2015 |
January 1, 2019 |
January 1, 2019 |
December 15, 2014 |
February 27, 2018 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
|
| 56 |
NCT02597504 |
Recruiting |
Development of a Neurocognitive Screening Test |
- Brain Concussion
- Mild Cognitive Impairment
|
- Other: Pen and paper neuropsychological test
- Device: Quick Test
|
Interventional
|
Not Applicable |
- ImPACT Applications, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Reliability will be established through a test-retest to establish results should be stable over time
- Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.
|
1600 |
All |
6 Years to 75 Years (Child, Adult, Older Adult) |
NCT02597504 |
QPR-15-44 |
|
October 2015 |
July 2018 |
|
November 5, 2015 |
May 4, 2018 |
|
- FastMed Urgent Care
Scottsdale, Arizona, United States - University of Arkansas
Fayetteville, Arkansas, United States - Head First
Crofton, Maryland, United States - Jim Gyurke
Pittsburgh, Pennsylvania, United States
|
|
| 57 |
NCT03624634 |
Recruiting |
Assessment of the Effects of Concussion on Adolescent Rugby Union Players |
- Concussion, Mild
- Concussion, Intermediate
- Concussion, Severe
|
|
Observational
|
|
- Sports Surgery Clinic, Santry, Dublin
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- 1) Clinical assessment - assessing change from baseline and between post-concussion visits
- 2) Questionnaire - assessing change from baseline and between post-concussion visits
- 3) Computerised cognitive assessment - assessing change from baseline and between post-concussion visits
- (and 9 more...)
|
131 |
Male |
15 Years to 19 Years (Child, Adult) |
NCT03624634 |
SSC-Concussion-001 |
|
August 1, 2016 |
December 2018 |
December 2018 |
August 10, 2018 |
August 10, 2018 |
|
- Sports Surgery Clinic
Dublin, Leinster, Ireland
|
|
| 58 |
NCT02658669 |
Recruiting |
CBT-I for Veterans With TBI |
- Insomnia
- Traumatic Brain Injury
|
- Behavioral: Cognitive-Behavioral Therapy for Insomnia
- Behavioral: Sleep Education
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Sleep Efficiency
- Change in depressive symptomatology
- Change in PTSD Stressor Specific Checklist 5
- Change in World Health Organization Disability Assessment Scale-2
|
60 |
All |
18 Years to 55 Years (Adult) |
NCT02658669 |
D1512-W |
|
April 1, 2016 |
August 31, 2020 |
September 30, 2020 |
January 20, 2016 |
August 14, 2018 |
|
- VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
|
|
| 59 |
NCT03397667 |
Recruiting |
The Aging Brain ANSWERS Program |
- Traumatic Brain Injury
- Alzheimer Disease
- Veterans
- (and 3 more...)
|
- Other: ABC ANSWERS
- Other: Control
|
Interventional
|
Not Applicable |
- Indiana University
- Richard L. Roudebush VA Medical Center
- Cleveland State University
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Change from baseline Caregivers Quality of Life at 12 months
- Change from baseline Veterans Quality of Life at 12 months
- Change from baseline Caregiver Burden at 12 months
- (and 5 more...)
|
400 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT03397667 |
#1706902669 |
ABC ANSWERS |
August 1, 2018 |
September 2020 |
December 2020 |
January 12, 2018 |
August 3, 2018 |
|
- Richard L. Roudebush VAMC
Indianapolis, Indiana, United States
|
|
| 60 |
NCT03597763 |
Recruiting |
Fatigue Following Moderate and Severe TBI |
- Traumatic Brain Injury
- Fatigue
|
|
Observational
|
|
- University of Oslo
- Extrastiftelsen
- Sunnaas Rehabilitation Hospital
- (and 2 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Fatigue Severity Scale
- Chalder Fatigue Questionnaire
- Giessen Symptoms Checklist - fatigue subscale
|
100 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03597763 |
2018/FO202360 |
|
March 1, 2018 |
January 30, 2020 |
January 30, 2020 |
July 24, 2018 |
July 24, 2018 |
|
- Sunnaas Rehabilitation Hospital
Nesoddtangen, Akershus, Norway - Oslo University Hospital
Oslo, Norway
|
|
| 61 |
NCT02657317 |
Recruiting |
Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans |
- Chronic Pain
- Traumatic Brain Injury
- Posttraumatic Stress Disorder
- (and 2 more...)
|
- Behavioral: FORT-A
- Other: VA Treatment as Usual
|
Interventional
|
Not Applicable |
- The University of Texas Health Science Center at San Antonio
- South Texas Veterans Health Care System
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Oswestry Disability Index
- Change in Lifting Capacity
- Change in Aerobic Capacity
- (and 4 more...)
|
130 |
All |
18 Years to 72 Years (Adult, Older Adult) |
NCT02657317 |
R01AT008422-01
HSC20140396 |
|
January 2016 |
August 2019 |
August 2019 |
January 15, 2016 |
September 24, 2018 |
|
- South Texas Veterans Health Care System
San Antonio, Texas, United States
|
|
| 62 |
NCT03598140 |
Recruiting |
Sildenafil Treatment for Mild TBI |
- Vascular System Injuries
- Concussion, Brain
- Post-Concussion Syndrome
|
- Drug: Sildenafil Citrate
- Drug: Placebo oral capsule
|
Interventional
|
Phase 2 |
- University of Texas Southwestern Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Arterial Spin Labeling
- Rivermead Post Concussion Symptoms Questionnaire (RPQ)
- Hopkins Verbal Learning Task (HVLT)
- BOLD MRI with hypercapnia
|
180 |
Male |
18 Years to 35 Years (Adult) |
NCT03598140 |
032018-063 |
|
July 25, 2018 |
June 30, 2021 |
December 31, 2021 |
July 25, 2018 |
August 28, 2018 |
|
- University of Texas Southwestern Medical Center
Dallas, Texas, United States
|
|
| 63 |
NCT02122458 |
Recruiting |
Blast Exposed Veterans With Auditory Complaints |
- Hearing Impairment
- Hearing Aid Fitting
|
- Device: mild-gain hearing aids
|
Interventional
|
Phase 1 |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Hearing Handicap
- Hearing Aid Benefit
- Intent to continue use
- (and 2 more...)
|
468 |
All |
20 Years to 50 Years (Adult) |
NCT02122458 |
C1164-R |
|
August 1, 2015 |
November 30, 2019 |
December 31, 2019 |
April 24, 2014 |
October 3, 2018 |
|
- VA Portland Health Care System, Portland, OR
Portland, Oregon, United States - VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States - Sioux Falls VA Health Care System, Sioux Falls, SD
Sioux Falls, South Dakota, United States
|
|
| 64 |
NCT02644265 |
Recruiting |
CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG |
- Acute Brain Injuries
- Consciousness Disorders
|
|
Observational
|
|
- Rigshospitalet, Denmark
- University of Copenhagen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Numbers of patients with acute brain injury and signs of preserved consciousness as revealed by fMRI- and EEG-based active, passive and resting state consciousness paradigms
|
100 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT02644265 |
CONNECT-ME 1.0 |
CONNECT-ME |
April 12, 2017 |
December 2021 |
December 2022 |
December 31, 2015 |
August 28, 2018 |
|
- Neurocentret, Rigshospitalet, Copenhagen University
Copenhagen, Denmark
|
|
| 65 |
NCT03023163 |
Recruiting |
A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences |
|
|
Observational
|
|
- James J. Peters Veterans Affairs Medical Center
- Kessler Foundation
|
U.S. Fed / Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Systolic Blood Pressure (mmHg)
- Performance on tests of memory (PASAT) and processing speed (SDMT).
- Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries
|
110 |
All |
28 Years to 75 Years (Adult, Older Adult) |
NCT03023163 |
WEC-16-039 |
|
December 2016 |
June 2019 |
June 2019 |
January 18, 2017 |
January 23, 2018 |
|
- Kessler Foundation Research Center
West Orange, New Jersey, United States
|
|
| 66 |
NCT02988596 |
Recruiting |
Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial |
|
- Other: Multidimensional Active Rehabilitation
- Other: Enhanced Graded Exertion
|
Interventional
|
Not Applicable |
- University of North Carolina, Chapel Hill
- Medical College of Wisconsin
- National Football League Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Average Days to Recovery
- Change in Fatigue from Baseline to 1 Month Post Return to Play
- Change in Quality of Life Perception (PROMIS) from Baseline to 1 Month Post Return to Play
- (and 9 more...)
|
420 |
All |
13 Years to 99 Years (Child, Adult, Older Adult) |
NCT02988596 |
16-1228 |
|
January 2017 |
August 2019 |
December 2019 |
December 9, 2016 |
August 23, 2018 |
|
- North Carolina Central University
Durham, North Carolina, United States - Elon University
Elon, North Carolina, United States - Orange County High School
Hillsborough, North Carolina, United States - (and 8 more...)
|
|
| 67 |
NCT03417492 |
Recruiting |
Cerebrovascular Reactivity in American Football Players |
- Traumatic Brain Injury
- Mild Traumatic Brain Injury
- Post-Concussion Syndrome
|
|
Interventional
|
Phase 1 |
- University of Pennsylvania
- Boston University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.
- Effect of single dose sildenafil citrate treatment on functional near-infrared spectroscopy (fNIRS) response to hypercapnia.
- Maximum tolerable dose of sildenafil therapy without severe adverse events.
|
30 |
Male |
40 Years to 65 Years (Adult, Older Adult) |
NCT03417492 |
827103 |
|
March 1, 2018 |
September 1, 2019 |
September 1, 2019 |
January 31, 2018 |
April 12, 2018 |
|
- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
|
|
| 68 |
NCT02969824 |
Recruiting |
Post-acute Structured Exercise Following Sport Concussion |
|
- Behavioral: Aerobic Exercise
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Treatment
|
- Clinical recovery - Days to Medical Clearance
- Change in Symptoms
- Change in Heart Rate Variability (HRV)
- (and 3 more...)
|
150 |
All |
13 Years to 25 Years (Child, Adult) |
NCT02969824 |
33459 |
|
February 16, 2017 |
January 2021 |
April 2021 |
November 21, 2016 |
April 9, 2018 |
|
- David L. MacIntosh Sport Medicine Clinic
Toronto, Ontario, Canada - Goldring Centre for High Performance Sport
Toronto, Ontario, Canada
|
|
| 69 |
NCT02748109 |
Recruiting |
Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI |
|
- Behavioral: Vestibular Rehabilitation + audio biofeedback
- Behavioral: Vestibular Rehabilitation
|
Interventional
|
Not Applicable |
- Oregon Health and Science University
- Portland VA Medical Center
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention.
- Change in Sensory Orientation Test (SOT) Composite Score
- Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores
- (and 14 more...)
|
130 |
All |
18 Years to 60 Years (Adult) |
NCT02748109 |
15010
CDMRP-MR141257 |
|
September 2015 |
September 2019 |
September 2019 |
April 22, 2016 |
October 9, 2017 |
|
- Oregon Health and Science University
Portland, Oregon, United States
|
|
| 70 |
NCT03104244 |
Recruiting |
Longitudinal Brain Health in Youth Tackle Football Players |
- Concussion, Brain
- Athletic Injuries
|
|
Observational
|
|
- More Foundation
- Riddell, LLC
- ElMindA Ltd
- S Dallas Rowe & Associates LLC
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Impact Monitoring (g force)
- Neurological history
- Neurological physical examination
- (and 7 more...)
|
280 |
Male |
9 Years to 19 Years (Child, Adult) |
NCT03104244 |
MoreFoundation |
|
July 2016 |
August 2020 |
August 2020 |
April 7, 2017 |
June 12, 2017 |
|
- The Sports Neurology Clinic at the CORE Institute
Brighton, Michigan, United States
|
|
| 71 |
NCT03256643 |
Recruiting |
Brain Injury Therapy of Exercise and Enriched Environment |
|
- Behavioral: Exercise
- Behavioral: Delayed Exercise
- Behavioral: Exercise and enrichment
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Trail Making Part B
- Quality of Life in Brain Injury Questionnaire
|
45 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03256643 |
123 |
BITEEE |
May 1, 2016 |
July 1, 2018 |
December 1, 2018 |
August 22, 2017 |
August 22, 2017 |
|
- Oakwood Heritage
Taylor, Michigan, United States
|
|
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