Clinical Research Directory

Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.

EXercise-induced PhysioLogical Adaptations In Neurological Disorders

The goal of this study is to investigate how a one-time exercise session influences different parameters of brain function in people with neurological diseases compared to healthy volunteers. The main questions the study aims to answer are: * How do fitness level, exercise performance, and physical exhaustion differ between patients with neurological diseases and healthy participants? * How does acute exercise affect brain function and other physiological biomarkers in participants with neurological diseases? Participants will take part in a single, one-day study visit and will be asked to: * Perform a standardized exercise test on a bicycle ergometer * Undergo a brain MRI (magnetic resonance imaging) scan, a blood draw, and autonomic measurements before and after the exercise test

Diffusion Tensor Brain MRI in the Detection of Structural Abnormality of the White Substance in Concussion

Concussions in sports are a major public health problem because of their frequency, and are often underdiagnosed because of an unspecific clinical picture or sometimes masked by the concussion itself. Support data has been constantly evolving in recent years, including the last publication of the Berlin Consensus in 2016 specifying support in the field. However, to date, there is no tool to predict the severity of a concussion or to predict when it will return to play objectively and reliably. Brain MRI done after the head injury is most often normal. However, previous studies agree that there is a persistent electrophysiologic disturbance several weeks after the injury, and the specific pathophysiology of white matter changes after a head injury remains controversial. Diffusion tensor imaging (DTI), in addition to morphological sequences, is capable of assessing white matter microstructure and fibrous tract integrity or not. Several parameters, such as the seemingly normal white matter fractional anisotropy (FA) coefficient, the mean diffusivity and the radial diffusivity, may be altered in the aftermath of a concussion, indicating axonal damage not visible on conventional MRI sequences. Previous studies have evaluated these parameters with sometimes contradictory results: some have found an increase in AF in specific regions such as the cortico-spinal tract and the corpus callosum, others have found a decrease in AF. So far, assessment of a player's condition on and off the field after a head injury has been based on clinical criteria alone, sometimes far too subjective. The player may choose to mask their symptoms to allow them to return to the game faster, or feign more than they have. Once pathologies such as bone fractures or intracranial hematomas are ruled out by conventional imaging, there is no longer any tool for a more accurate diagnosis of possible microstructural alterations of brain tissue and for monitoring of the patient. The advent of new MRI techniques such as diffusion imaging, and particularly diffusion tensor imaging (DTI), is a promising tool to better understand white matter involvement in diffuse axonal lesions.

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.

BCAAs in Concussion 2.0

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.

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 21 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.

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.

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.

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).

Dynamic Vision Testing and Concussion Management

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

A Comparison of Dynamic Vision Between College Athletes & Controls

The purpose of this study is to establish baseline reference values for tests of static and dynamic visual acuity and gaze stabilization in collegiate athletes and non-athletes, and to determine if there are differences in vision scores between collegiate athletes and non-athletes with and without a history of concussion.

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.

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.

Olfactory Training in Various Populations

To date, there is no validated pharmacotherapy for olfactory disorders. Interestingly, olfactory training - the intentional exposure to odorants for the purposes of retraining the sense of smell - has shown success with as many as 28% of subjects over the course of 12 weeks.

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.

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.

" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "

Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired

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.

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.

NFL LONG Prospective Study

The purpose of this 5-year prospective research study is to characterize the association between concussions, sub-concussive exposure, and long-term neurologic health outcomes in former NFL players. To achieve the study aims, the investigators will conduct detailed research visits that include clinical outcome assessments, blood-based biomarkers, advanced magnetic resonance imaging (MRI), positron emission tomography (PET) using investigational tracers and genetic testing. Ultimately, the goal of this study is to translate the findings from this study into clinical, interventional studies for at risk former NFL players.

The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.

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.

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.

Investigation of Neurocognitive Measures of Sport-Related Injury

The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.