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129 Concussion Trials Near You
Power is an online platform that helps thousands of Concussion patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerThe purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs.
Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Other Brain Injury, Neurological Disorder, Psychosis
360 Participants Needed
Electrical Stimulation Therapy for Post-Concussion Syndrome
Iowa City, Iowa
This study is investigating the immediate and long-term effects of bilateral cerebellar transcranial direct current stimulation on cognition, balance, and symptom severity in people with sports-related post-concussion syndrome. The central hypothesis is that tDCS will provide improvements in cognitive deficits, balance, and overall symptom attenuation in people with SRPCS both acutely and at 2 and 4 week follow ups. The researchers further hypothesize that cerebellar tDCS will ameliorate the symptoms of people with SRPCS.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 30
Key Eligibility Criteria
Disqualifiers:Seizure Disorders, Diabetes, Psychosis, Others
Must Not Be Taking:Psychoactive Medications
31 Participants Needed
Group Wellness Interventions for Neurologic Conditions
East Hanover, New Jersey
Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Stroke, Neurological Disease, Seizures, Others
360 Participants Needed
Hyperbaric Oxygen Therapy for Concussion
Marshfield, Wisconsin
The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Female, Prisoner, Severe GCS, Others
10 Participants Needed
Osteopathic Manipulative Treatment for Head Injuries
Greenvale, New York
The purpose is to test how osteopathic medicine (OMM) improves recovery after a hit to the head during Mixed Martials Arts (MMA). The small changes in the bone, joints, and fluids during head injuries may lead to traumatic brain injury (TBI). The OMM is adjusting the body with the doctors' hands. The goal is to restore alignment and release tension. The head is treated with the doctors' hands placed gently on the head or face. It was previously found to improve symptoms and recovery of memory after head injuries in college athletes. There haven't been clinical trials of this procedure in MMA fighters. Yet, they often get injuries to the part of the brain that releases hormones. Referrals for tests for the hormones are available. Individuals who participate in MMA fighting or sparring matches may join this study. Those who don't get hit in the head or a concussion will contribute to our understanding the osteopathic structural physical exam and fluid dynamics of the head in relation to brain function tests. Those who get hit in the head may be put in the treatment procedure or sham-placebo group. Participants will not be told which group they are in. We anticipate that 100 individuals of any gender will enroll in this study at NYIT Academic Health Care Center (AHCC). To be in this study, the participant must:
Part 1 - Before the fight:
1. Plan to participate in an MMA fight or sparring match,
2. 18 to 50 years of age,
3. Be able to do online cognitive neuropsychology tests for memory, reaction time, and symptoms.
Part-2-After the fight:
(1) Have been hit in the head, or had a head injury, during a fight
The participant cannot be in this study if they have:
Part 1- Before the fight:
1. a current or previous spinal cord injury,
2. a traumatic brain injury within the past six months,
3. inability to tolerate the sports physical,
4. a diagnosis of brain degeneration,
5. low hormones levels from the brain,
6. Pregnancy Participants won't get referred for hormone testing if they don't have any clinical signs of this injury. They also won't get referred for it if they've had heart disease, disease of the blood vessels in their brain, or seizures.
Participants cannot be in Part-2-After the fight if they:
1. cannot tolerate OMM (For example, you have a skull fracture, cervical spine fracture, bleeding or increased pressure in the head, tearing of tissues in the neck, space-occupying lesion, or stroke).
2. were knocked out for more than 2 minutes, had seizures, persistent vomiting, or paralysis when your head was hit.
Participation involves 2 or 4 visits, which will take place over one week.
* The first visit takes 30 mins. in-person and 70 mins. of online testing from home.
* The second visit takes 30-60 mins. in-person and 70 mins. of online testing from home.
* The third \& fourth visits will each be 30 mins. in-person and 70 mins. online testing from home.
If participants agree to be in this study, they will be asked to do the following:
Visit #1: Before the Fight
* Get screened and review the consent form
* Take the neuropsychology tests (ImPACT and Inquisit Web) online from home
* Get a non-invasive sports physical exam of head, neck, back, arms, and legs.
* Urine sample for the hormone from the brain called oxytocin (optional)
* Have blood sugar checked by a lancet after pricking the finger (optional) Fight video: The study-doctors will record the participants' fights to make a computational model of the head.
Visit 2: After the Fight
* Get a sports physical of head, neck, back, arms, and legs.
* IF the participant was hit in the head, the study-doctors or participants private doctor will examine them.
* Take the ImPACT and Inquisit Web tests online from home
* If the participant had an injury to their brain, they may get the OMM procedure or sham placebo-control (non-therapeutic light touch).
* Urine sample for the hormone from the brain called oxytocin (optional)
* Have your blood sugar checked by a lancet after pricking your finger (optional)
* Referral to your doctor to test the levels of other brain hormone (optional)
Visit 3 \& 4:
* Sports physical of head, neck, back, arms, and legs
* Take the ImPACT and Inquisit Web tests online from home
* If you had an injury to your brain, you may get the OMM procedure or sham placebo-control (nontherapeutic light touch). You will not be told which one you are getting.
* Urine sample for oxytocin (optional)
* Have blood sugar checked by a lancet after pricking your finger (optional)
* Referral to test the levels of other brain hormone (optional) Any significant new findings that develop during research that may relate to the participants health or willingness to continue will be provided to them by phone call. The results will help us understand head injuries, how well OMM works to treat them, and may improve future care for fighters.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Spinal Cord Injury, TBI, Pregnancy, Others
100 Participants Needed
Cervical Spine Musculature for Concussion
Rochester, Minnesota
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.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:12 - 30
Key Eligibility Criteria
Disqualifiers:Neck Conditions, Head Lice, Pregnancy
4000 Participants Needed
Anesthesia's Impact on Neurocognitive Function After Concussion
Rochester, Minnesota
Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:16+
Key Eligibility Criteria
Disqualifiers:Not Listed
52 Participants Needed
Transcranial Magnetic Stimulation for Concussion
Saint Paul, Minnesota
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Substance Use, Others
20 Participants Needed
Brain Stimulation + Cognitive Training for Mild Traumatic Brain Injury
Minneapolis, Minnesota
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Brain Tumor, Epilepsy, Schizophrenia, Bipolar, Others
160 Participants Needed
Olfactory Training for Loss of Smell
Kansas City, Kansas
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.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Dementia, Parkinson's, Others
250 Participants Needed
Gamma Wave Therapy for Traumatic Brain Injury
Boston, Massachusetts
Combat Veterans of post-9/11 conflicts have experienced serious cognitive and emotional problems resulting from exposure to blasts. Recent work suggests that a critical factor influencing the consequences of blast exposure is distance from the blast, rather than the presence or absence of concussion symptoms. Exposure to blasts from a distance of \<10 m has been associated with significantly greater cognitive and neural problems than exposure to blasts from \>10 m. So far, the effects of blast-related brain injury on the brain are poorly understood, as to date the effects of blast exposure have received little research focus. The investigators propose to use oscillations in the gamma band (30-100 Hz) of the electroencephalogram (EEG; brain waves) to detect and remediate neural circuit dysfunction related to blast injury in Veterans. If successful, this project could lead to new approaches to detect and remediate the effects of blast exposure on Veterans and aid in their functional recovery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Neurological Illness, Seizure Disorders, Schizophrenia, Others
50 Participants Needed
Neurofeedback for Concussion-Related Light Sensitivity
Boston, Massachusetts
The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Stroke, Neurodegenerative Disease, Epilepsy, Others
Must Not Be Taking:Photosensitivity Drugs
36 Participants Needed
High-Dose Exercise for Concussion Recovery
Cambridge, Massachusetts
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:13 - 18
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Exercise Contraindications, Others
216 Participants Needed
Nerve Blocks for Post-Traumatic Headache
Boston, Massachusetts
Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them.
The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH.
Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:14 - 45
Key Eligibility Criteria
Disqualifiers:Not Listed
63 Participants Needed
Sleep Extension for Concussion
North Andover, Massachusetts
Concussions are incredibly common, and often result in severe and long lasting symptoms, including, but not limited to, sleep deprivation and emotion dysregulation. This study aims to demonstrate the therapeutic benefits of sleep extension (napping) on emotion regulation in individuals after they sustain a concussion. Thus, sleep extension may be a cost-effective, low risk, supplemental treatment for those with emotion dysregulation following a concussion. The main questions it aims to answer are:
1. Is a nap an effective way to improve emotion regulation in individuals with a concussion?
2. Does a nap reduce the required executive resources necessary to regulate emotions in individuals with a concussion?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 35
Key Eligibility Criteria
Disqualifiers:Astigmatism, Sleep Disorder, Shift Worker, Others
60 Participants Needed
Exercises for Concussion
Boston, Massachusetts
This study aims to investigate the effect of two different physical exercise interventions on the brain, cognition and patient reported outcomes following a mild traumatic brain injury (mTBI) in community-dwelling adults.
Physical exercise as an intervention for mTBI has great potential yet there is limited high-quality evidence of its effect. Additionally, while standardized exercise protocols for sport-related concussion exist, a similar program is not available to members of the general public who have suffered a mTBI. This study therefore aims to test the effect of a 3-month exercise protocol either focusing on balance or aerobic exercises. The results from the study may lead to advances in evidenced-based mTBI management and provide clinicians with an effective intervention that can improve brain and cognitive recovery after mTBI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Moderate-to-severe TBI, Neurological Condition, Cardiac Conditions, Others
24 Participants Needed
Planning and Incentives for Traumatic Brain Injury
Boston, Massachusetts
The purpose of this research is to learn if different behavioral interventions can change walking behaviors over 12-weeks, in older adults who have previously suffered a non-penetrating mild or moderate TBI.
Participants will provide information and be screened for eligibility via phone screening call (verification of age, confirmation that the participant is not currently on any medication that affects the central nervous system, and verification that the subject can participate in exercise, brief TBI history). Baseline testing will take place at the Center for Cognitive and Brain Health and Northeastern University Biomedical Imaging Center, for the baseline magnetic resonance imaging, in the interdisciplinary science and engineering complex on Northeastern University's campus. In person testing will take place over one session. The study period lasts 12 weeks, during which all participants will 1. Receive a weekly phone call with study staff and 2. Wear a wrist-worn Fit Bit tracker. A remote participation option is available for those who cannot travel to Northeastern University.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Severe TBI, Neurological Condition, Others
Must Not Be Taking:CNS Medications
60 Participants Needed
Y-Balance Test for Predicting Concussion Risk
Fort Smith, Arkansas
The Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. The process is repeated in the posterior medial, and the posterior lateral directions. The final values are controlled for leg length of the participants. The YBT-LQ has been shown to be predictive of lower extremity injury in high school basketball players, but it is typically used as part of a battery of tests to determine the athlete's overall injury risk, but more questions remain to be answered. The research question: Is the YBT-LQ predictive of concussion in high school athletes? What are the norms for YBT-LQ in high school athletes? Does history of concussion effect YBT-LQ? Is the YBT-LQ with visual perturbations predictive of concussions? Is the YBT-LQ with visual perturbations predictive of lower extremity injury? What is the impact of visual perturbations on Y-balance and its injury prevention capability?
The target student participants will be 9th through 12th grade students; however, 6th to 8th grade students will be allowed to participate depending on the school or organization request. Informed consent will be obtained reiterating that participation is voluntary. Testing utilizing the YBT-LQ will occur, and sport of participation, age, height, weight, dorsiflexion, and leg length will be obtained. Follow up will be made via the athletic trainers and school personnel to indicate the effected athletes. Once the post-test follow up is complete athletes will be able to see their pre-test scores, and any questions will be answered at that time. This will be a longitudinal study where testing will take place at least two times per year, preferably three times per year over 4 years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 19
Key Eligibility Criteria
Disqualifiers:History Of Seizure
1000 Participants Needed
Hyperbaric Oxygen Therapy for Post-Concussion Syndrome
Fargo, North Dakota
Persistent post-concussive symptoms (PPCS) are a source of significant burden among a subset of patients with concussion with prevalence rates previously reported between 11 - 82% based on timing of assessment, diagnostic criteria, or population under study.
Examples of persistent post-concussion symptoms include balance problems, headaches, fatigue, poor concentration, forgetfulness, anxiety, irritability, and sleep disturbance. Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury.
The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms.
The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Psychotic Disorders, Severe TBI, Others
40 Participants Needed
The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.
Specific Aims:
1. Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms \>3 months after injury.
1. Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
2. Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.
3. Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).
2. Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:COPD, Uncontrolled HTN, Pregnancy, Others
Must Not Be Taking:Antabuse, Antiseizure, Meclizine, Others
100 Participants Needed
Why Other Patients Applied
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
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.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55+
Key Eligibility Criteria
Disqualifiers:Moderate/severe Brain Injury, Stroke, Heart Attack, Substance Use, Others
Must Not Be Taking:HD-tDCS Altering
75 Participants Needed
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 18
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Psychosis, Spinal Cord Injury, Others
304 Participants Needed
The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.
Trial Details
Trial Status:Completed
Age:50+
Key Eligibility Criteria
Disqualifiers:Not Listed
24 Participants Needed
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in military veteran participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Dementia, Epilepsy, Severe TBI, Others
Must Not Be Taking:Anticonvulsants, Amphetamines, Dopaminergics, Others
80 Participants Needed
Hyperbaric Oxygen Therapy for Traumatic Brain Injury
Fort Lauderdale, Florida
Mild traumatic brain (mTBI) injury affects 400,000 U.S. Veterans resulting in physical, cognitive and mental health symptoms. The Department of Defense (DoD) reported 26 suicides a day from mTBI despite ongoing care for the Veterans. The purpose of this pilot research study is to evaluate the effect of treating Veterans suffering from mTBI or persistent post-concussion syndrome with hyperbaric oxygen therapy (HBOT).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Sex:Male
Key Eligibility Criteria
Disqualifiers:Female, Major Depression, Schizophrenia, Alcoholism, Others
Must Not Be Taking:Steroids, Immunosuppressants, Bleomycin, Doxorubicin
40 Participants Needed
I-PAS Goggles for Concussion Diagnosis
Miami, Florida
This trial tests if the I-PAS goggle system can reliably diagnose mild brain injuries in urgent care or emergency settings.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Neuropsychiatric Disorders, Neurodegenerative Disorders, Pregnancy, Others
400 Participants Needed
Photobiomodulation Therapy for Sports Concussion
Houston, Texas
The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to standard of care in adolescent athletes at risk for delayed recovery from subacute sports concussion, to substantiate the impact of subacute PBMt over time on functional and structural connectivity of the brain using advanced MRI sequences and to correlate the psychological and behavioral outcomes to neuroimaging findings
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 18
Key Eligibility Criteria
Disqualifiers:Epilepsy, Schizophrenia, Bipolar, Others
Must Not Be Taking:Benzodiazepines, Anticonvulsants, Mood Stabilizers, Others
30 Participants Needed
Dietary and Nutritional Interventions for Post-Concussion Syndrome
Moncton, New Brunswick
Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms.
This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16+
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Severe Brain Injury, Others
120 Participants Needed
Behavioral Therapy for Insomnia in Concussions
Fort Cavazos, Texas
This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Urgent Psychiatric Disorder, Others
160 Participants Needed
Biofeedback-Based Rehabilitation for Concussions
San Antonio, Texas
Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Stroke, Severe Brain Injury, Pregnancy, Others
100 Participants Needed
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Frequently Asked Questions
How much do Concussion clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Concussion clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Concussion trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Concussion is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Concussion medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Concussion clinical trials?
Most recently, we added Rehabilitation for Concussion, Transcranial Magnetic Stimulation for Concussion and Tranexamic Acid for Reducing Bruising After Dermal Filler to the Power online platform.
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