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146 Traumatic Brain Injury Trials
Power is an online platform that helps thousands of Traumatic Brain Injury 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.
Hyperbaric Oxygen Therapy for Traumatic Brain Injury
Columbus, OhioThis trial aims to find the best way to use hyperbaric oxygen treatment for patients with severe brain injuries. The treatment involves breathing pure oxygen at high pressure to help heal the brain. Researchers want to determine the safest and most effective settings for this treatment. Hyperbaric oxygen therapy is an existing and approved treatment for various medical conditions, including decompression sickness, air or gas embolism, and carbon monoxide poisoning.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:16 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnant, Pre-existing Neurologic Disease, Others
200 Participants Needed
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14+
Sex:All
Key Eligibility Criteria
Disqualifiers:Non-survivable Injury, Sepsis, Pregnancy, Others
1094 Participants Needed
InfraScanner 2000 for Traumatic Brain Injury
Dayton, OhioIn this study, investigators look at a different type of technology that might help to avoid having to perform CT scans in certain patients suspected of having a head injury. Near-infrared spectroscopy (NIRS) uses a specific light wavelength to determine if there is bleeding into the head as a result of trauma. Investigators will study NIRS, using a device called the Infrascanner model 2000, to determine if it is as good at detecting bleeding in the head as CT scan, which is the current gold standard. Investigators will try to determine if NIRS can rule in or rule out bleeding into the head, and perhaps this can help to avoid subjecting these youth to the potentially harmful effects of radiation. Investigators will also study how easy it is to use NIRS so that it might become a standard part of the workup for children with suspected head injury.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:< 18
Sex:All
400 Participants Needed
Brain Wave Monitoring for Traumatic Brain Injury
Cincinnati, OhioThis study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Non-survivable Injury, Pregnancy, Others
72 Participants Needed
Transcranial Electrical Stimulation for Traumatic Brain Injury
Cincinnati, OhioThe two goals of the proposed study are: (1) To determine how brain activity changes with cognitive recovery over time from acute to chronic phases of traumatic brain injury (TBI). (2) To determine how the time of anodal transcranial electrical stimulation (A-tES) administration affects cognitive performance and brain activity in TBI.
To achieve these study goals, the investigators will conduct a pilot clinical trial over three years in which the investigators aim to recruit 60 patients with moderate to severe TBI at the University of Cincinnati Medical Center (UCMC). During the acute phase of TBI, all participants will complete clinical questionnaires and perform 2 cognitive computer tasks while their brain activity is recorded. Half of the participants will be randomly selected to receive A-tES for 15 minutes while performing cognitive tasks and the other half will receive sham stimulation. All participants will be followed for 6 months. During their 3-month follow-up, the investigators will perform another session where all participants complete the questionnaires and receive A-tES while performing cognitive tasks during brain recording. In their last visit at 6 months post-injury, all participants will complete the questionnaires and cognitive tasks with brain recording but no stimulation treatment. From the collected data, the investigators will determine if time from brain injury correlates with brain activity during performance of cognitive tasks. The investigators will also assess the efficacy of early A-tES treatment for improving cognitive task performance and clinical test ratings at 6 months post-injury in comparison to A-tES delivered during the 3-month follow-up visit.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 80
Sex:All
60 Participants Needed
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Substance Abuse, Schizophrenia, Bipolar, Others
100 Participants Needed
Medical Cannabis for Chronic Pain
Sandusky, OhioThis trial will investigate if medical cannabis can effectively reduce pain and improve quality of life for patients with chronic conditions. The study will gather data through an online questionnaire about patients' use of cannabis and its effects. Medical cannabis interacts with the body's natural system to help manage pain and other symptoms. Medical cannabis has been increasingly studied and used as an alternative treatment for managing chronic pain, with numerous studies supporting its potential benefits.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:7+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Suicidality, Psychosis, Others
200000 Participants Needed
Pro-2-Cool Device for Concussion
Akron, OhioThis study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 21
Sex:All
72 Participants Needed
Cafe Therapy for Traumatic Brain Injury
Cleveland, OhioThe goal of this study is to learn if a enhanced environment (Metro Café) with multi model approach (an approach that combines several therapies) in chronic traumatic brain injury improves outcomes of recovery better than traditional therapy. The main questions it aims to answer are:
* Determine the amount of therapy dosage (speech, cognition, arm and leg movements) obtained during the Metro Café therapy session.
* Evaluate the connection between environmental enrichment dosage (the Metro Café) and clinical outcome scores.
Researchers will compare Metro Café Treatment to those who do not receive this treatment to see if better improvements in function after a traumatic brain injury are seen in the Metro Café Treatment Participants will train in the Metro Cafe during the 2-month gap between assessments, for a total of 18 training sessions, each up to 2 hours, 3 times per week. Participants will greet and serve customers drinks and snacks, maintain food supplies at the counters and performs housekeeping tasks with advice and assistance from a supervising researcher as needed,
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
20 Participants Needed
Amantadine for Traumatic Brain Injury
Detroit, MichiganThe main goal of this clinical trial is to check if the treatment is safe and well-tolerated. Researchers will compare the MR-301 active drug group with the placebo group to evaluate the safety and tolerability of the drug. Other measurements include assessing the patient's overall outcome, neurological responses, time spent in the intensive care unit, time in the hospital, and mortality. Participants will receive either MR-301 BID IV dosing or a matching placebo for a total of 3 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Spinal Cord Injury, Seizures, Others
Must Not Be Taking:Amantadine, CNS Stimulants, Others
45 Participants Needed
Multi-Drug Therapy for Traumatic Brain Injury
Pittsburgh, PennsylvaniaThe purpose of this study is to determine if experimental drug treatment improves recovery after TBI as compared to a control (placebo) group. Changes in recovery will be measured throughout the study. The study drugs listed below are approved by the U.S. Food and Drug Administration (FDA) but are being used "off-label" in this study. This means that the drugs are not currently approved to treat TBI.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:18 - 65
Sex:All
672 Participants Needed
Acceptance and Commitment Therapy for Traumatic Brain Injury
Pittsburgh, PennsylvaniaThe primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with mTBI-related vestibular symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Cavazos, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 49
Sex:All
Key Eligibility Criteria
Disqualifiers:Vestibular Disorder, Neurological Disorder, Cervical Spine Injury, Others
250 Participants Needed
Targeted Treatments for Concussion
Pittsburgh, PennsylvaniaThe purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Stroke, Dementia, Epilepsy, Schizophrenia, Others
50 Participants Needed
Targeted Multidomain Intervention for Concussion
Pittsburgh, PennsylvaniaObjective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 49
Sex:All
169 Participants Needed
Growth Hormone Therapy for Human Growth Hormone Deficiency
Dearborn, MichiganThis 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).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 76
Sex:Male
Key Eligibility Criteria
Disqualifiers:Brain Disease, Diabetes, Malignant Disease, Others
42 Participants Needed
Wellness Programs for Disabilities
Pittsburgh, PennsylvaniaPeople with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:7+
Sex:All
130 Participants Needed
nVNS for Traumatic Brain Injury-Induced Acute Respiratory Distress
Pittsburgh, PennsylvaniaThis trial is testing a device that stimulates a nerve in the neck, along with usual medical care, to help patients with mild-to-moderate brain injuries. The goal is to prevent serious complications like severe inflammation and breathing problems.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, COPD, Heart Failure, Others
46 Participants Needed
Combination Therapies + Lifestyle Modifications for Traumatic Brain Injury
Ann Arbor, MichiganThis trial tests if combining talking therapy, brain exercises, and lifestyle changes can help people with neurocognitive disorders live better lives by improving their thinking, brain function, and daily habits.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Depression, Substance Abuse, Others
Must Not Be Taking:Steroids
56 Participants Needed
MHealth System for Chronic Health Conditions
Pittsburgh, PennsylvaniaThis study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Intellectual Disability, Psychiatric Illness, Others
160 Participants Needed
Blood Test for Concussions
Detroit, MichiganDecision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Cancer, Pregnancy, Others
900 Participants Needed
Exercise Tests for Concussions
Pittsburgh, PennsylvaniaThis study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Vestibular Disorder, Cardiac Disease, Others
Must Not Be Taking:Antidepressants, Anticoagulants, Beta-blockers, Anticonvulsants
60 Participants Needed
Diagnostic test for Traumatic Brain Injury
Pittsburgh, PennsylvaniaThis study will establish the capability of a suite of conventional tests and the Neurolign Dx_100 I-PAS goggle system to reliably and objectively detect mTBI in an acute setting when comparing individuals with mTBI to controls with minor injuries in a similarly stressful environment.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:All
450 Participants Needed
Erenumab for Post-Traumatic Headache
Pittsburgh, PennsylvaniaThis study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Moderate/severe TBI, Chronic Migraine, Others
404 Participants Needed
VestAid App for Dizziness
Pittsburgh, PennsylvaniaThis multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:All
80 Participants Needed
Buspirone for Traumatic Brain Injury Irritability and Aggression
Indianapolis, IndianaThis trial is testing buspirone, a medication usually used for anxiety, to see if it can help reduce irritability and aggression in people who have had a traumatic brain injury. The study involves 74 participants who will receive buspirone. The goal is to see if buspirone can make a positive difference in their behavior by calming the brain. Buspirone is a new anxiolytic agent that has been shown to reduce aggression and anxiety without causing sedation or cognitive side effects.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Psychosis, Neurologic Disease, Others
Must Not Be Taking:Buspirone
74 Participants Needed
BEST Teletherapy for Traumatic Brain Injury
Indianapolis, IndianaTo examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
40 Participants Needed
ICARE Treatment for Traumatic Brain Injury
Indianapolis, IndianaThis trial tests a remote rehab program called ICARE to help people with brain injuries and their caregivers improve emotional understanding and relationships. It aims to teach them how to better recognize and respond to emotions, enhancing their relationship quality and emotional well-being.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Suicide Risk, Major Psychiatric, Others
80 Participants Needed
IPN10200 for Upper Limb Spasticity
Farmington Hills, MichiganThis trial is testing a medication called IPN10200 to see how safe and effective it is for adults with stiff muscles in their arms. Researchers are trying different doses to find the best one that works well without causing too many side effects. The goal is to help reduce muscle stiffness in these patients.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 70
Sex:All
240 Participants Needed
RCBI Program for TBI Recidivism Reduction
Greencastle, IndianaThis trial aims to help people with brain injuries who are being released from prison by providing a special program that supports their unique needs. The goal is to reduce their chances of going back to prison and committing violent crimes by offering tailored services that help them manage their behavior and integrate into the community.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
102 Participants Needed
Magnesium and Riboflavin for Concussion-Related Headaches
Charlottesville, VirginiaThis clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 40
Sex:All
108 Participants Needed
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Frequently Asked Questions
How much do Traumatic Brain Injury 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 Traumatic Brain Injury 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 Traumatic Brain Injury 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 Traumatic Brain Injury 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 Traumatic Brain Injury 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 Traumatic Brain Injury clinical trials ?
Most recently, we added BRILLIANT Platform for Brain Injury, Cognitive Rehabilitation for Traumatic Brain Injury and Aerobic Exercise for Head Injuries to the Power online platform.