Filter Results
Conditions
Locations
Treatment Type
Trial Phase
Trial Status
Paid Participation
Clear All
122 Concussion Trials
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.
COACH Intervention for Concussion Prevention
Winston-Salem, North CarolinaHead impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:11 - 14
Sex:All
880 Participants Needed
Cervical Rehabilitation for Concussion Symptoms and Neck Pain
Pittsburgh, PennsylvaniaAssess the feasibility of recruiting, enrolling and randomizing patients with concussion symptoms and neck pain to receive manual therapy and cervical rehabilitative exercises in addition to standard concussion treatment.
In the usual care workflow provided at the participating concussion clinic, cervical spine rehab is not typically introduced until after week 4. The rationale is that neck pain is often a self-limiting condition that may resolve spontaneously, without the need for specific cervical spine rehab.
This study is chiefly focused on feasibility aims that revolve around developing changes to barriers in workflow issues at the participating concussion clinic, that would allow for earlier introduction of cervical spine rehab.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Previous Concussion, Ischemic Events, Substance Use, Others
40 Participants Needed
Hyperbaric Oxygen Therapy for Concussion
Marshfield, WisconsinThe 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
Age:18+
Sex:Male
10 Participants Needed
SPINEPASS Physical Therapy for Post-Concussion Headache
San Antonio, TexasThis is a prospective randomized controlled trial comparing two different physical therapy approaches to the treatment of posttraumatic headache with autonomic symptoms. AIM 1: To establish the efficacy of SPINEPASS against Standard Physical Therapy to reduce headache disability and impact amongst patients with persistent post-concussion headache. AIM 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of headache. Demonstrate its appropriateness, acceptability, and feasibility and gain patient insights among patients with PPTH compared to standard PT.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
120 Participants Needed
Rehabilitation for Concussion
San Antonio, TexasPurpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment.
Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 64
Sex:All
222 Participants Needed
Cognitive Rehabilitation for Concussion
Seattle, WashingtonMild traumatic brain injury (mTBI) affects millions of individuals worldwide every year. It has long been thought that the vast majority of individuals who sustain a mTBI experience natural recovery with little or no intervention and return to baseline functioning within days to weeks of injury. However, recent large studies have demonstrated that a substantial number of individuals experience prolonged symptoms (e.g., cognitive impairment, headaches, affective symptoms). These symptoms, termed "Persistent Post-concussive Symptoms" (PPCS) are associated with significant functional disability and reduced quality of life (QOL) and can last for years post-injury. While PPCS can include affective, cognitive, and somatosensory/vestibular symptoms, objective and subjective cognitive symptoms - particularly in the domains of attention, memory, processing speed, and executive function - are among the most commonly reported following mTBI. There is currently no gold-standard intervention to address these symptoms. To address this gap, our research group developed a brief cognitive rehabilitation intervention called Tools for Rehabilitation and Cognitive Care (or On-TRACC).
The goals of this clinical trial are:
AIM 1: Compare the efficacy of On-TRACC to a psychoeducation control on reduction of self-reported cognitive post-concussive symptoms (Aim 1.1) and overall neurobehavioral post concussive symptoms and (Aim 1.2) following treatment and at 3-month follow-up (Aim 1.3) in a randomized clinical trial of community-dwelling adults with mTBI.
AIM 2: Compare the efficacy of On-TRACC and psychoeducation on change in secondary outcomes, including cognitive self-efficacy, compensatory strategy use, self-management skills, and quality of life at post-treatment and 3-month follow-up.
Exploratory AIM 3: Compare the efficacy of On-TRACC and psychoeducation on: primary and secondary outcomes at 6-months post-treatment and (Aim 3.1) explore whether engaging in On-TRACC leads to subsequent engagement in care by assessing whether there is a different level of participation in optional intervention booster sessions in the post-intervention period (Aim 3.2).
All participants will:
* Complete a series of assessments
* Complete 6 treatment sessions via telehealth (either On-TRACC or psychoeducation)
All participants will have the option of:
* Attending weekly "Booster Sessions" between 3 and 6-months post-treatment
* Completing neuropsychological assessments at 2 timepoints during the study
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
354 Participants Needed
Tranexamic Acid for Reducing Bruising After Dermal Filler
Madison, WisconsinThe goal of this clinical trial is to look at the effect tranexamic acid (TXA) may have on reducing bruising, swelling, and pain after facial filler injection. The main question it aims to answer is:
* Does the addition of TXA to hyaluronic acid (HA) reduce bruising, swelling, and tenderness after HA injection?
Participants will receive the study medication along with the standard facial filler injection and complete surveys.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 89
Sex:All
40 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
Neurostimulation Device for Motion Sickness
San Antonio, TexasThe purpose of this research study is to learn how a wearable nerve stimulation device, the Spark Biomedical's Sparrow Ascent System™, impacts the development of spatial disorientation and/or motion sickness in a healthy population.
Spatial disorientation is when there is a "mismatch" between where a person is, and where the sense organs in their body tell them where they are. These sense organs include the inner ear (the vestibular system), the eyes (the visual system), the sense of where one's legs, back, and neck are (proprioceptive system), and one's higher thinking (cognitive centers). If spatial disorientation is severe or occurs in motion-naïve individuals, spatial disorientation can lead to motion sickness.
The Sparrow Ascent System™ is a wearable, battery-operated transcutaneous auricular (ear) neurostimulation (tAN) device. This means that it uses electrical pulses to stimulate branches of nerves on and/or around the ear, specifically the "vagus" and "trigeminal" nerves. These nerves are also responsible for your sensation of nausea and your heart rate (vagus nerve), as well as headaches (trigeminal nerve). The Sparrow System utilizes a flexible earpiece with embedded hydrogel electrodes that stick to the skin, the earpiece is disposable after use. This device is already Food and Drug Administration (FDA) approved for use in humans and is safely used for control of symptoms in a variety of other medical conditions, such as opioid withdrawal and acute stress reaction. In this study, we will determine if the Sparrow Ascent System™ impacts the development of spatial disorientation or motion sickness.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:All
36 Participants Needed
The 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
Age:18+
Sex:All
360 Participants Needed
Sleep Extension for Concussion
North Andover, MassachusettsConcussions 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
Sex:All
60 Participants Needed
THC for Driving Performance
Madison, WisconsinThis study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 49
Sex:All
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Pregnancy, Others
Must Not Be Taking:Mood Stabilizers, Sedatives
5 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
Somatropin for Growth Hormone Deficiency and Concussion
Decatur, GeorgiaThis trial is testing if giving extra growth hormone can help improve the quality of life for adults who have low growth hormone levels and mild brain injuries. Growth hormone treatment has been shown to improve quality of life in adults with growth hormone deficiency.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:21 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Schizophrenia, Cancer, Others
Must Not Be Taking:Growth Hormone, Estrogen, Progestin, Others
172 Participants Needed
Brain Stimulation and Augmented Reality for Concussion
Hamilton, OntarioThis study aims to determine whether the delivery of brain stimulation paired with a balance training task can improve symptoms of dizziness for individuals experiencing these symptoms due to concussion. The main questions it aims to answer are:
* Does repetitive transcranial magnetic stimulation (rTMS) paired with balance training improve the symptoms of dizziness in individuals with persistent dizziness due to concussion?
* Is the proposed rTMS and balance training protocol feasible in this population?
Researchers will compare results from a sham rTMS group with those from a real rTMS group to see if any observed changes are from the placebo effect rather than the expected effects of real rTMS.
Participants will receive pulses of rTMS to the area of the brain responsible for control of movement and then be asked to interact with digital objects using augmented reality glasses for 14 days over 3 weeks.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
40 Participants Needed
rTMS for TBI-related Depression
Bethesda, MarylandThe purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure History, Bipolar, Schizophrenia, Others
Must Be Taking:Psychotropic Medications
198 Participants Needed
Behavioral Therapy for Insomnia in Concussions
Fort Cavazos, TexasThis 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
Sex:All
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Urgent Psychiatric Disorder, Others
160 Participants Needed
Daridorexant for Delirium After Heart Surgery
Rochester, New YorkThe goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.
Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.
Trial Details
Trial Status:Completed
Trial Phase:Phase 2
Age:60+
Sex:All
11 Participants Needed
Osteopathic Manipulative Treatment for Head Injuries
Greenvale, New YorkThe 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
Sex:All
Key Eligibility Criteria
Disqualifiers:Spinal Cord Injury, TBI, Pregnancy, Others
100 Participants Needed
Psilocybin for Post-Concussion Syndrome
Calgary, AlbertaThe goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persistent post-concussion symptoms (PPCS).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PPCS
AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PPCS
Participants will be asked to:
* Complete a 2 part screening process
* Attend a baseline assessment
* Complete a psychoeducation preparation session(s)
* Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\])
* Complete 5-6 weekly sessions of BrainACT
* Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
40 Participants Needed
Auditory Plasticity Training for Traumatic Brain Injury
San Antonio, TexasThe investigators are working on a project to help people who have had mild brain injuries hear better. Sometimes, these injuries can make it hard for people to hear clearly, especially in noisy places or when trying to tell where sounds are coming from.
The project is testing special training exercises that have helped healthy people improve their hearing in these situations. The goal is to see if these exercises can also help people with mild traumatic brain injuries (mTBI).
If these exercises work, they could help doctors give better treatment to people with hearing problems after a brain injury. This would be especially helpful for soldiers who need to stay ready for duty. It could also make life better for veterans who struggle with hearing issues and help lower the cost of healthcare.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Major Neurological, Psychiatric Conditions, Others
80 Participants Needed
Education Strategies for Concussions
Milwaukee, WisconsinThe purpose of this study is to develop and validate ways to provide better patient education and clinical management for individuals who go to the emergency department (ED) with concussion or mild traumatic brain injury (mTBI).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18+
Sex:All
5831 Participants Needed
Aerobic Exercise for Concussion
Fayetteville, North CarolinaOur primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe TBI, Orthopedic Injury, Substance Abuse, Others
Must Not Be Taking:ADHD Medication, Mood Stabilizers
168 Participants Needed
Brain Stimulation + Cognitive Training for Mild Traumatic Brain Injury
Minneapolis, MinnesotaThe 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
Sex:All
Key Eligibility Criteria
Disqualifiers:Brain Tumor, Epilepsy, Schizophrenia, Bipolar, Others
160 Participants Needed
Quetiapine for Post-Concussion Syndrome
San Antonio, TexasA two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Schizophrenia, Bipolar, Others
Must Be Taking:CNS Active Psychotropics
146 Participants Needed
Biofeedback-Based Rehabilitation for Concussions
San Antonio, TexasCurrent 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
Sex:All
Key Eligibility Criteria
Disqualifiers:Stroke, Severe Brain Injury, Pregnancy, Others
100 Participants Needed
Aerobic Exercise for Concussion
Williamsville, New YorkThere 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Polytrauma, Substance Abuse, Others
40 Participants Needed
Active Rehabilitation for Concussion
Fort Liberty, North CarolinaThe 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Third MTBI, Moderate-Severe TBI, Polytrauma, Others
130 Participants Needed
The investigators hope to develop a treatment for suicidal ideation (SI), impulsivity and functional impairments (such as difficulties in social and work settings) that occur after a mild traumatic brain injury (mTBI). These conditions have been shown to be linked. The investigators are using a high-powered magnetic pulse, called intermittent theta burst stimulation (iTBS) applied to the head to see if it can improve these symptoms. The high-powered magnetic pulse causes certain cells in the brain to activate, which seems to strengthen connections between parts of the brain. The purpose of this research is to gather early information on the safety and effectiveness of iTBS provided to the front of the head for impulsivity, SI and functional deficits after mTBI. The investigators plan to use the data collected in this study to develop larger studies in the future. iTBS is FDA approved, but not for these specific symptoms, or in the specific location the investigators are placing it. The investigators are testing to see if its effective for the above conditions when applied to the front of the head.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:22 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Epilepsy, Claustrophobia, Substance Use Disorder, Others
55 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
Page 1 of 5+
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 COACH Intervention for Concussion Prevention, Cervical Rehabilitation for Concussion Symptoms and Neck Pain and Hyperbaric Oxygen Therapy for Concussion to the Power online platform.