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24 Post-Concussion Syndrome Trials Near You
Power is an online platform that helps thousands of Post-Concussion Syndrome 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 PowerThis trial tests if a cognitive behavioral therapy program called C-STEP can help children with ongoing concussion symptoms. The program includes education, activity management, sleep tips, and relaxation training.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:10 - 18
Key Eligibility Criteria
Disqualifiers:Not Listed
40 Participants Needed
MeRT for Post-Traumatic Stress Disorder
Columbus, Ohio
This trial is testing a new treatment called MeRT, which uses magnets to help people with PTSD by improving their brain function.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Cerebrovascular Accident, Schizophrenia, Bipolar, Others
Must Not Be Taking:Antipsychotics, Benzodiazepines, Anticonvulsants, Others
152 Participants Needed
Photobiomodulation for Post-Concussion Syndrome
Toronto, Ontario
This trial is investigating the use of light therapy to help people who have had a mild brain injury and are struggling with sleep problems not caused by sleep apnea. The therapy aims to improve their sleep and mental functions by stimulating brain activity with light. This approach is being tested because these patients often do not get better with other treatments. Light therapy is emerging as a potential treatment for improving sleep and physiological functions, though research on its full-body applications is still limited.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
20 Participants Needed
Rehabilitation for Persistent Concussion Symptoms
Toronto, Ontario
Protocol Summary
The present study was developed to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced electroencephalography (EEG) when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The EEG changes will be compared to the standardized clinical examination findings as well as the RPQ.
Sample Size:
N= 50
Study Population
Participants will be eligible for study participation if they meet the following inclusion criteria: 21-years and older; diagnosed with postconcussion syndrome; and have adequate language skills in English to read and take part in rehabilitation treatment program. Participants will be excluded should: they have an unremarkable or normal clinical examination; have a chronic infectious disease; uncontrolled hypertension; other neurological disorders (not attributed to their primary diagnosis); cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities; those with pacemakers or elevated cardiovascular risk; ongoing litigation surrounding their injury; have been diagnosed with a moderate or severe brain injury prior to enrolment; post-concussive symptoms persisting beyond 12-months.
Study Design
The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6-weeks. At the end of 12-weeks, participants will undertake the endpoint examinations.
Start Date:
May 2023
End Date:
September 2025
Primary Objective:
The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21+
Key Eligibility Criteria
Disqualifiers:Chronic Infectious Disease, Uncontrolled Hypertension, Other Neurological Disorders, Cancer Treatment, Others
Must Not Be Taking:Psychoactive Medications
50 Participants Needed
Risk Stratification Tool for Post-Concussion Syndrome
Toronto, Ontario
Patients with Persisting Concussion Symptoms (PCS) have a multitude of different symptoms. Some patients are at risk of prolonged symptoms but currently there is no tool to assist in identifying patients at high risk. Intensive, multidisciplinary intervention is time-consuming and expensive and may not be warranted for all PCS patients, so it is essential to identify early on which patients are at risk of prolonged symptoms. The aim of this study is to improve the quality of care delivered to patients, especially those who are at high-risk of prolonged PCS by early identification and treatment of all the symptoms. The purpose of this research is to validate the use of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool (RST).
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
75 Participants Needed
Theta-Burst Stimulation for Post-Concussion Syndrome
Toronto, Ontario
The current study aims to better understand the efficacy of intermittent theta-burst stimulation (iTBS) treatment in patients diagnosed with post-concussion syndrome (PCS) and to explore changes in brain networks after undergoing iTBS to assess its safety and feasibility in treating PCS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Substance Dependence, Pregnancy, Others
Must Not Be Taking:Anticonvulsants, Antiepileptics, Benzodiazepines
10 Participants Needed
Theta-Burst Stimulation for Post-Concussion Syndrome
Toronto, Ontario
TMS has been safely and reliably delivered at the Harquail Centre for over 5 years, with a primary focus on conventional rTMS protocols for treatment-resistant depression. Recently, the investgator team has gained the capability to deliver sham-controlled intermittent theta-burst stimulation (iTBS) rTMS. Unlike conventional high frequency rTMS, which was used in the previous sham-controlled rTMS PCS pilot study, iTBS is a patterned form of stimulation that recapitulates endogenous activity patterns of neural circuits pairing gamma frequency (50Hz) burst pulses coupled in a theta frequency rhythm (5Hz).12 iTBS delivers 600 pulses in just over 3 minutes with similar or greater effects on neural plasticity compared to conventional rTMS (taking over 30-45 minutes) and similar tolerability and efficacy in trials of depression. Furthermore, novel accelerated iTBS protocols stimulating the left dorsolateral prefrontal cortex (dlPFC) over 8-10 treatments, 50 minutes apart over a 5 day interval has recently demonstrated robust efficacy in depression and received recent FDA approval. Thus, accelerated iTBS can be delivered in a single week of treatment compared to 6 weeks with conventional rTMS methods. Finally, the investigators recently acquired the technology to integrate MRI neuroimage-guided stimulation, which would allow to target specific brain regions/networks implicated in PCS at high spatial resolution. No studies to date have investigated image-guided accelerated iTBS rTMS for the treatment of PCS.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Substance Dependence, Pregnancy, Others
Must Not Be Taking:Anticonvulsants, Antiepileptics, Benzodiazepines
26 Participants Needed
Vision Therapy for Post-Concussion Syndrome
Philadelphia, Pennsylvania
Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of office-based vergence and accommodative therapy (OBVAT) that is effective in remediating symptoms. Adolescent and young adult concussion is considered a substantial health problem in the United States where our team has shown that about half of patients with persistent post-concussion symptoms have convergence insufficiency (PPCS-CI), causing significant negative impact associated with reading or digital screen-related activities, and is believed to be one factor causing delayed recovery impacting return to school, sports, or work. The results of this randomized clinical trial will impact the lives of adolescents and young adults with PPCS-CI to guide professionals on how to manage and treat those with PPCS-CI by 1) comparing the differences between PPCS-CI and TYP-CI, 2) discovering the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and 3) determining the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:11 - 35
Key Eligibility Criteria
Disqualifiers:Amblyopia, Strabismus, Diabetes, Others
100 Participants Needed
rTMS for Post-Concussion Syndrome
Syracuse, New York
This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Chronic Headaches, Neurologic Conditions, Others
Must Not Be Taking:CNS Medications
30 Participants Needed
Chiropractic Adjustment for Post-Concussion Syndrome
Marietta, Georgia
This proof-of-concept trial will explore the effects of manual chiropractic adjustments on nervous system function in individuals with post-concussion syndrome. This study will aim to recruit 10 individuals to receive 6 weeks of chiropractic care with 3 assessment periods. The participants will undergo a baseline assessment, mid-trial assessment, and post-trial assessment. The participants will wear an electroencephalography (EEG) cap for a neural assessment during an event related potential. They will wear electrical diodes to measure electrocardiography (ECG), impedance cardiography (ICG), and electrodermal activity (EDA) throughout the study and during an orthostatic challenge. Additional sensors will be placed on the participant to measure interlimb symmetry patterns during gait while walking on a treadmill.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Malignant Hypertension, POTS, Others
Must Not Be Taking:Short-acting Benzodiazepines
10 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
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
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
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
SPINEPASS Physical Therapy for Post-Concussion Headache
San Antonio, Texas
This 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
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Relocation, Others
Must Not Be Taking:Botox
120 Participants Needed
Quetiapine for Post-Concussion Syndrome
San Antonio, Texas
A 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 (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Schizophrenia, Bipolar, Others
Must Be Taking:CNS Active Psychotropics
146 Participants Needed
Brain Stimulation for Concussion
Albuquerque, New Mexico
The goal of this clinical trial is to test a new type of magnetic brain stimulation in patients with persistent post-concussive symptoms. Participants will undergo detailed MRI scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the study aims to answer are:
* Will this new type of treatment result in fewer symptoms and better daily functioning?
* What are the effects of this treatment on brain functioning?
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Not Listed
15 Participants Needed
Psilocybin for Post-Concussion Syndrome
Calgary, Alberta
The 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 Acceptance and commitment therapy (ACT)
* 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
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Schizophrenia, Bipolar, Epilepsy, Others
40 Participants Needed
Why Other Patients Applied
"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
"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 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
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"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
PENFS for Post-Concussion Syndrome
Orange, California
This trial tests a small device that sends electrical signals through tiny needles on the outer ear to help children with pain, post-concussion symptoms, and post-COVID-19 symptoms. The electrical signals aim to reduce pain and improve brain function by stimulating nerves in the ear. The use of electrical currents for the treatment of disease has been considered since antiquity but it has only been in recent years that suitable devices have been available to scientific investigators to provide stimulation currents for clinical use.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 18
Key Eligibility Criteria
Disqualifiers:Seizure Disorders, Developmental Delay, Others
125 Participants Needed
Brain Stimulation for Post-Concussion Syndrome
Westwood, California
The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS).
The investigators intend to answer the questions:
1. Does personalized TMS improve brain connectivity after concussion?
2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms?
3. Do the improvements last up to 2 months post-treatment?
4. Are there predictors of treatment response, or who might respond the best?
Participants will undergo 14 total visits to University of California Los Angeles (UCLA):
1. One for the baseline symptom assessments and magnetic resonance imaging (MRI)
2. Ten for TMS administration
3. Three for post-treatment symptom assessments and MRIs
Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Neurologic Deficits, Severe Mental Problems, Others
75 Participants Needed
MSTEP for Concussion
Seattle, Washington
This trial tests a new exercise program called M-STEP that uses fitness trackers and video calls to help young people aged 11-18 recover from long-lasting concussion symptoms. The program aims to speed up recovery by gradually increasing physical activity and reducing fear of symptoms.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:11 - 18
Key Eligibility Criteria
Disqualifiers:Non-English, Other Injuries, High Activity, Others
200 Participants Needed
Neurofeedback for Post-Concussion Syndrome
Honolulu, Hawaii
This study will evaluate neurofeedback (NFB) training as a low risk, non-invasive, effective treatment for Veterans diagnosed with mild traumatic brain injury (mTBI) and experiencing chronic post-concussive symptoms (PCSs). It is being funded by the Department of Veterans Affairs. Doing this study will help to determine if NFB will reduce chronic headaches and enhance sleep, attention and quality of life in Veterans with mTBI.
NFB is like other biofeedback processes in which information about a person's specific body functioning is made known to the person through a special computer program, which can help that person make the specific body function work better through training. This type of training is usually fun and easy with the help of a coach and a computer. Nothing is ever put into a person's body with biofeedback and it is natural and safe. When a person becomes focused, calm and alert while training on an NFB system, the computer will recognize this and let the trainee know by automatically displaying on the computer screen the positive progression of the game they are playing, such as the plane moving forward or a flower opening. The brain really likes to be in this pattern and when it is happening, people feel good. As a result, any discomforts, like headaches or insomnia, experienced may decrease.
After learning about the study, Veterans who agree to participate will be randomly placed into one of two groups, either an intervention group (who will receive NFB) or a control group (who will receive only usual care plus once a week 15-minute calls on health topics). Veterans will have an equal chance of being in either group. Those placed in the control, will also receive NFB after completion of the control group activities. Veterans who are placed in the intervention or delayed intervention group will receive NFB up to 5 times a week, but usually 3 times a week for a total of 20 sessions. Each session is an hour long.
Both the intervention and control group will participate in four assessment sessions (lasting up to 2 1/2 hours each) that involve completing 12 questionnaires and a 20-minute attention evaluation. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. The participant will receive financial compensation for taking the baseline assessment, 4-6 week, 8-10-week assessments, and for the 2-month follow-up assessment. A participant will receive financial compensation for gas, time and valet parking for each intervention and assessment session. Participation in this research will last about 4 months for those in the intervention and 8 months for those in the delayed intervention group. All participants will receive the NFB treatment by the end of the study.
A person who participates in this study may experience a reduction in his or her chronic headaches, and an enhancement of sleep, attention and quality of life. There may be a worsening of symptoms until the individualized training plan for a person can be identified. During an NFB session, brief moments, lasting only seconds or minutes, of dizziness while sitting, muscle tension, or tingling may be experienced. Most people feel relaxed and calm during and after NFB training.
This project will be an important step towards a broader implementation of an evidence-based treatment solution for Veterans experiencing chronic headaches, insomnia and attention disorders. The experience of these chronic symptoms can lead to debilitation in all areas of Veterans' lives. This project will provide evidence for the use of NFB with Veterans to alleviate their chronic symptoms and enhance their quality of life. If supported, NFB will offer the investigators' Veterans an effective and non-invasive treatment option. NFB is a patient focused intervention that enables Veterans the opportunity for self-health management.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
87 Participants Needed
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Frequently Asked Questions
How much do Post-Concussion Syndrome 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 Post-Concussion Syndrome 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 Post-Concussion Syndrome 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 Post-Concussion Syndrome 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 Post-Concussion Syndrome 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 Post-Concussion Syndrome clinical trials?
Most recently, we added Transcranial Magnetic Stimulation for Concussion, SPINEPASS Physical Therapy for Post-Concussion Headache and Psilocybin for Post-Concussion Syndrome to the Power online platform.
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