Concussion, Brain

20

Review clinical trials related to Concussion, Brain. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jul 13, 2026Locations: 5
Eligibility criteria

Current or former member of the uniform services [+7]

History of neurological diseases other than TBI and not attributable to TBI [+2]

Status: Not yet recruiting

BCAAs in Concussion 3.0

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.

Participants needed: 150
Trial details
Phase: Phase 2Age: 11-23Biological sex: AllType: InterventionalSponsor: Akiva CohenUpdated: Jun 26, 2026
Eligibility criteria

Males and females,11 - 23 years of age. [+5]

Evidence of moderate or severe TBI, including GCS <13, TBI requiring hospital ad... [+5]

Status: Recruiting

Creatine Supplementation in Concussion Recovery

The proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine.Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic.Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic. The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, The investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (Sport Concussion Office Assessment Tool-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine.

Participants needed: 20
Trial details
Age: 18-35Biological sex: AllType: InterventionalSponsor: San Diego State UniversityUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

18-35 years old with a diagnosed concussion within 72 hours post-injury

Learning disability, renal disease, mental behavior or migraine history, and cur...

Status: Recruiting

The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls

The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD). The main questions it aims to answer are: * What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports? * Is this proportion higher to that in control patients without a diagnosis of RBD? Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices. Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ.

Participants needed: 140
Trial details
Age: 50+Biological sex: AllType: ObservationalSponsor: Guy's and St Thomas' NHS Foundation TrustUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Tr... [+3]

Age < 50 years of age. [+9]

Status: Recruiting

REhabilitation of MEMory Symptoms After BRain Concussion

Persistent memory symptoms after concussion are common, and likely perpetuated by unhelpful illness beliefs and coping behaviors. Results from a pilot study suggested that traditional cognitive rehabilitation and a novel cognitive-behavioral therapy (CBT) protocol were both associated with improvements in subjective memory functioning. The present study will more definitively compare the effectiveness of these interventions for improving subjective memory functioning after concussion.

Participants needed: 184
Trial details
Age: 18-59Biological sex: AllType: InterventionalSponsor: University of British ColumbiaUpdated: Jun 2, 2026Locations: 8
Eligibility criteria

Age 18-59 [+5]

Fail performance validity testing [+1]

Status: Recruiting

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: May 28, 2026Locations: 5
Eligibility criteria

Current or former member of the uniform services [+7]

History of neurological diseases other than TBI and not attributable to TBI [+2]

Status: Recruiting

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.

Participants needed: 75
Trial details
Phase: Phase 2Age: 55+Biological sex: AllType: InterventionalSponsor: University of Texas Southwestern Medical CenterUpdated: May 6, 2026Locations: 1
Eligibility criteria

Active diagnosis of amnestic mild cognitive impairment [+5]

Mild traumatic brain injury within past year [+8]

Status: Recruiting

Modulating Exercise Dosage to Improve Concussion Recovery

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

Participants needed: 216
Trial details
Phase: Phase 2Age: 13-18Biological sex: AllType: InterventionalSponsor: University of Colorado, DenverUpdated: May 6, 2026Locations: 3
Eligibility criteria

13-18 years of age [+2]

Pre-existing neurological disorders [+2]

Status: Recruiting

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.

Participants needed: 72
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: University of California, San DiegoUpdated: May 1, 2026Locations: 1
Eligibility criteria

Male or female [+12]

History of moderate, severe, or penetrating TBI [+11]

Status: Recruiting

Interest of an Attentional Evaluation by a Computerized Battery in the Management of Concussion in Young Rugby Players

The goal of this study is to test the ability of a computerized neuropsychological battery to identify attentional disorders resulting from a concussion occurring during the practice of rugby. Thirty young people with a concussion (11-25 years old) will take several neuropsychological tests. Researchers will compare their results with those of young athletes without concussion to see the effect of concussion.

Participants needed: 90
Trial details
Age: 11-25Biological sex: MaleType: InterventionalSponsor: University Hospital, Clermont-FerrandUpdated: Apr 30, 2026Locations: 1
Eligibility criteria

concussion in the context of the practice of rugby [+6]

Legal protection measure [+14]

Status: Recruiting

A Pragmatic Rehabilitation Intervention: The Active Rehab Study

The strategic objective of this research line is to examine improving short- and long-term outcomes for soldiers following mild traumatic brain injury (mTBI). The technical objectives are to: 1) conduct a Phase 1 quasi-experimental pragmatic trial testing the potential benefit of provider directed active rehabilitation therapies ("Active Rehab") in accelerating return of injured soldiers back to active duty and improving cognitive and functional limitations following mTBI, and 2) operationalize and disseminate a clinical active rehabilitation algorithm for use in military settings. The central hypothesis is that an active rehabilitation algorithm in the context of the progressive return to activity will improve clinical and functional outcomes, including time to return to duty. The Active Rehab intervention expands on progressive return to activity guidelines by providing activities that can be completed and progressed during Stage 1 of the progressive return to activity protocol, when the participant is at least 24 hours postinjury. Active Rehab includes an adaptive paradigm based on personal characteristics, symptom presentation, and duty requirements that integrate with current progressive return to activity guidelines. Activity progressions consider the initial presentation and changes in participant status during treatment, with the goal of safely accelerating recovery. Severity and presence of symptoms will guide progression: worse, same or better as reported by the participant.

Participants needed: 130
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: University of North Carolina, Chapel HillUpdated: Feb 27, 2026Locations: 2
Eligibility criteria

Current active duty military personnel stationed at Fort Bragg, North Carolina. [+2]

Third mTBI/concussion in the past 12 months as indicated by the medical record a... [+3]

Status: Recruiting

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.

Participants needed: 75
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: University of California, Los AngelesUpdated: Feb 24, 2026Locations: 1
Eligibility criteria

Mild traumatic brain injury (mTBI) defined in accord with the World Health Organ... [+2]

objective neurologic deficits [+6]

Status: Not yet recruiting

Ecological Test Standardization for Concussion Assessment in Football Players

Concussion is a major concern in the sports world. It represents an immediate and transient alteration of neurological functions due to a direct or indirect trauma, with or without loss of consciousness. Concussions affect between 1.6 and 3.8 million people per year in the United States across all sports. The prevalence varies depending on the sport. In France, the incidence of sport-related concussions is estimated at 200,000 cases. According to the French Academy of Medicine (March 2025), concussions account for between 5% and 9% of all sports-related injuries. Among these cases, 30% involve individuals aged 5 to 19. Football (soccer) is one of the most affected sports, with its 2 million registered players. In French professional football (Ligue 1 and 2), during the 2023-2024 season, one concussion was recorded every 55 matches on average (declared concussion). During the 2018-2019 and 2019-2020 seasons, the rate of matches with concussion was approximately 2.5%. In professional rugby, it is estimated that one concussion occurs every three matches in France. There are no precise statistics on the number or frequency of concussions in amateur football in France, due to a lack of reporting and insufficient diagnosis. Currently, practical recommendations exist for managing football players from the moment of impact on the field, implemented within the French Football Federation. The current concussion protocol includes a standardized tool for evaluating concussion intended for healthcare professionals, the SCAT6. However, this protocol is not always sufficient, and return-to-play sometimes occurs too early. Indeed, current assessments are too brief and do not evaluate all cognitive functions. They do not allow a clear understanding of the real on-field consequences. It is estimated that 50% of athletes return to play too early after a concussion, with risks of neurological complications or prolonged symptoms. However, defining rest time and return-to-play criteria is not straightforward. In practice, return to play relies, among other things, on neuropsychological tests, whose interpretation is difficult in the absence of baseline data. The concussion protocol does not allow for an accurate determination of whether performance has normalized without this neuropsychological baseline. Recent European and international recommendations advise conducting pre-season assessments to provide comparative values. Several studies have been published on the type of pre-season assessments to perform, most using paper-and-pencil or computerized neurocognitive tests. The current concussion protocol relies mainly on paper-and-pencil tests. However, the literature shows dissociations between cognitive performance measured in ecological environments and performance measured through paper-and-pencil tests. Ecological tasks have the advantage of closely approximating the daily actions of a player and assessing cognitive functioning more precisely. Thus, these ecological tasks, combined with a baseline assessment, would improve the evaluation of athletes following a concussion. These tasks would facilitate return-to-play decisions through more objective observations and normed data. Finally, ecological tasks would enhance player monitoring and allow a more accurate understanding of their health status. For this reason, it seems necessary to develop a standardized ecological test performed in real-game situations. This would improve decision-making regarding return to play without medically endangering the player and would allow better understanding of the cognitive effects of concussion. These tasks will first be reviewed and tested by experts (players, football staff members, national concussion reference physician, and neuropsychologists) for feedback and refinement.

Participants needed: 100
Trial details
Age: 16+Biological sex: MaleType: InterventionalSponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUpdated: Feb 24, 2026Locations: 1
Eligibility criteria

Male professional football players from French clubs [+7]

History of concussion in the past 6 months (for inclusion, a statement from the... [+1]

Status: Recruiting

Risk Stratification in Children With Concussion

This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Findings will provide novel insights into the longer-term effects of concussion on children's physical, psychological, and social well-being and support the development of personalized healthcare and school-based plans to reduce disparities in children's ability to return-to-learn and -play and improve postconcussion quality of life.

Participants needed: 500
Trial details
Age: 11-17Biological sex: AllType: ObservationalSponsor: Duke UniversityUpdated: Aug 1, 2025Locations: 1
Eligibility criteria

Diagnosed with concussion that occurred within the past 7 days [+2]

Diagnosed with moderate or severe traumatic brain injury [+3]

Status: Recruiting

Objective Concussion Assessment Using MRI and Metabolomics

Mild traumatic brain injury (mTBI), also referred to as concussions, affect millions of people around the world and can cause harmful long term effects. Unfortunately, concussions can be hard to diagnose and many people have lasting post-concussion symptoms such as headaches, difficulty concentrating, and light sensitivity. Recent studies have shown that advanced magnetic resonance imaging (MRI) techniques can identify subtle brain changes caused by a concussion. This study aims to track concussions over time measuring MRI brain scans and post-concussion symptoms to gain a better understand how the brain is affected in comparison to symptoms.

Participants needed: 100
Trial details
Age: 9-50Biological sex: AllType: ObservationalSponsor: St. Joseph's Healthcare HamiltonUpdated: May 15, 2025Locations: 1
Eligibility criteria

Aged between 9-50 [+1]

Aged 8 and younger or 51 and older [+12]

Status: Recruiting

Concussion Health Improvement Program

More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.

Participants needed: 304
Trial details
Age: 11-18Biological sex: AllType: InterventionalSponsor: Seattle Children's HospitalUpdated: Mar 13, 2025Locations: 1
Eligibility criteria

11-18 years old [+2]

Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization... [+3]

Status: Recruiting

The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes

The goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. The main questions it aims to answer are: * Does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time? * Does the intensity of the exercise prescription also influence the aforementioned outcomes? Participants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. They will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. Researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.

Participants needed: 46
Trial details
Age: 18-25Biological sex: AllType: InterventionalSponsor: University of VirginiaUpdated: Dec 9, 2024Locations: 1
Eligibility criteria

Collegiate athlete (varsity) [+1]

If advanced neuroimaging was performed, any subject with a structural abnormalit... [+3]

Status: Recruiting

The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms

The purpose of this study, is to investigate whether creatine monohydrate as a supplement reduces the number and severity of symptoms in patients with persistent post-concussive symptoms through self-reported post-concussion symptoms questionnaires.

Participants needed: 45
Trial details
Age: 20-45Biological sex: AllType: InterventionalSponsor: Psychiatric Research Unit, Region Zealand, DenmarkUpdated: Jul 12, 2024Locations: 1
Eligibility criteria

Have had PPCS for a minimum of six months and a maximum of 18 months at the star... [+1]

Elite athletes, as well as people who in general is physical active, at an inten... [+4]

Status: Not yet recruiting

The Impact of Eye and Body Training on the Injury Rate of Concussions in Female Soccer Players

The research project aims to find out how special training influences the frequency and severity of injuries among female footballers in the top Swiss league. The project also aims to help establish normative values that are specifically tailored to women. The participating clubs will be randomly assigned to a comprehensive pre-season baseline examination with training recommendations based on the performed examinations (intervention group) or control group (normal training). Over the course of the 2024/2025 season, both groups will be compared in terms of the incidence and severity of concussions and musculoskeletal injuries. Initial results will be available in spring 2025 to coincide with the start of the European Women's Football Championship. The investigators' hypothesis is that the training recommendations in the intervention group will lead to a lower incidence of concussions and that the players will show better injury prevention as a result of these exercises.

Participants needed: 209
Trial details
Biological sex: FemaleType: InterventionalSponsor: BrainCare Medical GroupUpdated: Jun 25, 2024
Eligibility criteria

Registered player for a club in the top Swiss soccer league [+2]

Symptomatic chronic diseases (e.g. tumor diseases, diabetes mellitus, cardiovasc... [+4]

Status: Recruiting

Growth Hormone Replacement Therapy for Retried Professional Football Players

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

Participants needed: 42
Trial details
Phase: Phase 2Age: 18-76Biological sex: MaleType: InterventionalSponsor: Center for Neurological StudiesUpdated: Feb 8, 2023Locations: 1
Eligibility criteria

The subject is willing to provide a signed and dated informed consent indicating... [+4]

History of pre-existing brain disease other than concussion or TBI [+6]