Filter Results
Conditions
Locations
Treatment Type
Trial Phase
Trial Status
Paid Participation
Clear All
125 Tb Trials
Power is an online platform that helps thousands of Tb 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.
BRILLIANT Platform for Brain Injury
Montreal, QuebecBackground: Cardiovascular and neurological conditions are major causes of disability worldwide. Early, intensive rehabilitation is essential but often challenging to access in current healthcare systems. In Canada, the direct and indirect costs of acquired brain injury (ABI) are substantial, emphasizing the need for improved rehabilitation services. In collaboration with four health regions and the Canadian Foundation of Innovation (CFI) funded BRILLIANT research group, we are implementing a digital health platform (the BRILLIANT platform), which includes five modules to address current gaps and support a person-centered integrated care continuum for cardiovascular and neurological conditions. In this stepped wedge randomized trial, we plan to implement and evaluate the use of the BRILLIANT Platform for improving transitions of care in the rehabilitation of ABI individuals in Quebec.
Methods: A stepped wedge cluster randomized trial will be conducted across four healthcare regions with eight programs. Eligible participants included new cardiovascular and neurological patients, caregivers, clinicians, coordinators, and managers. The BRILLIANT platform intervention, implemented in 2 phases, will provide standardized assessments, communication tools, shared intervention plans, self-management support, and quality improvement dashboards. Outcomes will include rehabilitation intensity measured in minutes, time from admission to rehabilitation, health-related quality of life, care experience, and costs. Data analysis will use mixed-effects models for quantitative data and content analysis for qualitative data.
Discussion: This study will provide valuable evidence on the effectiveness and feasibility of the BRILLIANT platform in improving rehabilitation care for patients with cardiovascular and neurological conditions in Quebec. We anticipate that by addressing the challenges and pursuing future directions, the implementation of this digital platform can contribute to improving patient outcomes and healthcare delivery.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
962 Participants Needed
Aerobic Exercise for Head Injuries
Amherst, New YorkThe purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
300 Participants Needed
Trauma-Informed Intervention for Substance Use Disorders
Pewee Valley, KentuckyThe overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:Female
264 Participants Needed
High-Density TBS for Healthy Adults
Baltimore, MarylandBackground:
Transcranial magnetic stimulation (TMS) uses magnetic pulses to affect brain activity. A type of TMS called theta burst stimulation (TBS) is approved to treat people with major depression. Researchers have developed a new form of TBS called high-density TBS (hdTBS). They hope hdTBS will work better than TBS. But first they need to test the new treatment in healthy adults.
Objective:
To test hdTBS in healthy adults. Also, to compare the aftereffects of hdTBS and TBS.
Eligibility:
Healthy adults aged 22 to 60 years.
Design:
Participants will have 5 clinic visits over 4 to 5 weeks. They must abstain from drugs and alcohol and limit caffeine before visits.
At their first visit, participants will be oriented to TBS. They will wear a cap and earplugs. A device with round coils will be placed near their head. When a brief electric current passes through the coil, it generates a magnetic pulse that stimulates the brain. Participants may feel a pulling sensation on the skin under the coil. Their fingers may move involuntarily.
At their next 4 visits, participants will receive either TBS or sham TBS. A sham TBS uses a low magnetic field to minimize the effects of the treatment. Participants will have 3 to 6 electrodes placed on 1 arm. These electrodes will measure the electrical activity in their muscles. Each TBS session will be videotaped.
At every visit, participants will answer questions about their health, including substance use. They will perform 2 tasks to test their thinking skills. They will perform a test on a computer to test their reaction time.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:22 - 60
Sex:All
35 Participants Needed
TMS for Opioid Use Disorder
Baltimore, MarylandBackground:
The purpose of this study is to understand how a type of brain stimulation, transcranial magnetic stimulation (TMS), may help those who use opioids such as heroin or methadone. TMS uses brief magnetic pulses to affect brain activity, and is approved by the FDA to treat some mental health problems and substance use. We will evaluate how TMS may help make it easier to make certain kinds of decisions that could help one manage their opioid use. Our findings may provide support for the use of brain stimulation as a treatment to reduce opioid use.
Objective:
To understand how TMS affects brain activity associated with decision making in people who do and do not use opioids.
Eligibility:
People aged 18 to 60 years with an OUD. Healthy volunteers are also needed.
Design:
Participants will have up to 3 clinic visits over 1 to 3 months.
All participants will be screened to check if they are eligible to take part in this study. This study is completed in two parts. All eligible participants will complete the first part of the study. In the first part, you will receive one baseline magnetic resonance imaging (MRI) scan so we can take pictures of your brain while you complete computer tasks in the scanner. In these tasks, you will be asked to identify colors of words, view different images and play a game in which you can win money. If you can safely receive TMS, you will be invited to complete the second part of the study. In this part of the study, you will receive TMS and MRI over 2 sessions. For TMS, a coil will be placed on your head and a short electrical current will pass through the coil to create a magnetic pulse that stimulates your brain. You will also repeat the MRI scan and computer tasks. During one of the TMS visits you will receive active or real TMS. In the other, you will receive sham or placebo TMS, which feels like real TMS but does not affect the brain. You will receive both types of TMS. In all sessions, your urine and breath will be tested for drugs and alcohol, and you will complete questionnaires about mood and health.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:All
60 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
Spinal Stimulation for Traumatic Brain Injury
Chicago, IllinoisThe purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
30 Participants Needed
Levetiracetam + Lacosamide for Seizure Prevention
Winston-Salem, North CarolinaThe purpose of this study is to assess the incidence of early post-traumatic seizures. The study will also assess the benefit of lacosamide compared to levetiracetam in regards to agitation and behavioral adverse effects in patients with moderate to severe traumatic brain injury requiring seizure prophylaxis.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
600 Participants Needed
External Cranial Prosthesis for Trephined Syndrome
Baltimore, MarylandPatients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as "Sunken Flap Syndrome" or "Syndrome of the Trephined." The goal of this clinical trial is to see if placing a prosthetic over patients' skull defects can prevent "Sunken Flap Syndrome."
The main questions are:
1. Can placing a prosthetic device over patients' skull defects prevent Sunken Flap Syndrome?
2. Can placing a prosthetic device over patients' skull defects decrease healthcare costs?
3. Can placing a prosthetic device over patients' skull defects improve recovery and return of brain function after decompressive craniectomy?
Patients that experience traumatic brain injuries, brain bleeds, and large strokes can build up high levels of pressure in the skull. When this pressure can't be controlled with medications, a life-saving surgery called a decompressive hemicraniectomy (DC) is often performed. In this surgery, a large portion of the patient's skull is removed to decrease pressure on the brain and decrease permanent damage.
After this surgery, many patients experience sinking of the brain in the skull as the pressure inside the head improves. The skull normally protects the brain from the outside environment. When large parts of the skull are removed, the brain is not able to regulate itself normally. This can lead to a number of problems, such as headaches, weakness, seizures, and even coma and permanent brain damage. This is referred to as "Sunken Flap Syndrome" (SFS) or "Syndrome of the Trephined" (SoT). After 3-6 months, patients can have the missing skull surgically repaired, which improves and sometimes fixes SFS, but the damage is sometimes too severe to be reversed.
There are reports of patients with SFS treated with custom-made prosthetics that cover the missing piece of skull. In this study, the researchers want to see if wearing a custom-made prosthetic can prevent patients from experiencing SFS. Patients will also receive additional non-invasive measurement to see if the prosthetic can improve brain function and recovery. Finally, the researchers want to know if the prosthetic is cost-effective by decreasing the frequency that patients see doctors or receive care to treat SFS.
Patients or the patient's medical decision makers will be asked if the patient wants to participate in the study after DC. If the patient or decision maker agrees to participate, the patient will be also asked if the patient wants to wear the prosthetic. The prosthetic is made of a common material used in other facial prosthetics. Patients that agree to wear the prosthetic will have a custom plate made for the participant.
All patients will receive the same post-operative care and appointments whether or not the prosthetic is worn. The participant will go to the normally scheduled post-operative doctor's appointments at 2 and 4 weeks after initial DC surgery. Patient's that agree to wear the prosthetic will receive it at the 4-week post-DC appointment. The participant will then be asked to wear it as much as possible, but to let the researchers know if the participant experiences any pain, itching, discomfort or other problems.
All patients will also be seen by the patient's physician before and after and after skull repair. At all appointments, patients will receive non-invasive testing of brain function. Recovery and rate of SFS will be compared between patients that do and do not wear the prosthetic.
Participants will:
* Go to the normally scheduled 2 and 4 week post-DC appointments
* Go to the normally scheduled pre- and post-skull repair appointments
* Receive additional non-invasive brain health testing at each appointment
Participants that agree to wear a prosthetic will:
* Receive the custom prosthetic at the 4-week post-DC appointment
* Wear the prosthetic as much as possible, including at night
* Take a brief survey about the prosthetic at the post-skull repair appointment
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
72 Participants Needed
Multiple Treatments for Brain Injury
Baltimore, MarylandThe Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning. An observational study will be conducted in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to determine the effectiveness and safety of each treatment, primarily through measuring post-treatment changes in PTSD symptoms and cognitive functioning.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
40 Participants Needed
Inhaled Nitric Oxide for Traumatic Brain Injury
Philadelphia, PennsylvaniaTraumatic brain injury (TBI) causes acute deficits in cerebral perfusion which may lead to secondary injury and worse outcomes. Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults. The investigators will perform a randomized controlled trial of iNO treatment in TBI patients acutely after injury. The investigators will then assess perfusion changes with optic neuromonitoring, blood biomarkers, and 6 month clinical outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
38 Participants Needed
TB006 for Parkinson's Disease
Indianapolis, IndianaThe primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Disorders, Cancer, Others
Must Be Taking:Levodopa-carbidopa
62 Participants Needed
Methadone vs Remifentanil for Pain in Craniotomy Surgery
Charlottesville, VirginiaPostoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality.
Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively.
In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery.
IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery.
The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:18 - 65
Sex:All
40 Participants Needed
Allopregnanolone for Traumatic Brain Injury
Durham, North CarolinaThis study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \[primary endpoints\]. The investigators will also determine if ALLO improves functional outcome \[secondary endpoint\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:21 - 62
Sex:All
132 Participants Needed
Omega-3 Fatty Acids for Brain Injury
Bloomington, IndianaThe purpose of the proposed double-blind, randomized placebo-controlled trial is to understand how supplementation with fish oil \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] promote brain health against soccer heading. The study involves taking DHA+EPA or placebo, questionnaires, blood draws, brain imaging, tests to evaluate heart function, and soccer headings.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30
Sex:All
Key Eligibility Criteria
Disqualifiers:Head Injury, Cardiovascular Diseases, Pregnancy, Others
Must Not Be Taking:Omega-3 Supplements
208 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
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
Shorter Regimens for Latent Tuberculosis
Toronto, OntarioOur study rationale is based on:
1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe;
2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs;
3. 4 months of Rifampin 10mg/kg (4R10) is the safest regimen, but is completed by \<80% of patients;
4. The safety of 2 months of Rifampin 20mg/kg (2R20) is similar to that of 4 months of Rifampin 10mg/kg (4R10), but completion is a concern;
5. 1-month regimens have promising efficacy;
6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg/kg (4R10), and head-to-head with each other.
OBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adults and children relative to the reference Tuberculosis Preventive Treatment (TPT) regimen. The shortest, safest, and best tolerated regimen identified in this Phase 2 trial will be tested for effectiveness and efficacy in a Phase 3 trial.
Specific Tuberculosis Preventive Treatment (TPT) regimens (All are daily and self-administered) Reference: Rifampin at a dose of 10 mg/kg/day for 4 months (4R10); Experimental: 1) Rifampin at 20 mg/kg/day for 2 months (2R20); (2) one month Levofloxacin and Rifapentine (1LP). At a later stage a 3rd experimental regimen will be selected and added: one another novel 1-2-month regimen identified from pre-clinical and clinical studies. When selected, this will be explained fully including preliminary data on safety and efficacy in an amended protocol and consent - which will be submitted for ethics and regulatory approval at that time).
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:5+
Sex:All
1800 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
i-STAT TBI Test for Traumatic Brain Injury
New York, New YorkAccording to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain Injury (TBI), which does not include many TBIs treated only in emergency departments, urgent care, primary care, or that are not evaluated by a clinician. Head CT is a critical component of care for severe TBI, however in mild TBI there is practice variation with a wider risk to benefit estimation for obtaining head CT imaging. Potential disadvantages of head CT include longer Emergency Department (ED) length of stay (LOS), higher costs, and diagnostic radiation exposure. The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. This biomarker test is cleared for use in adults with mild TBI (Glasgow Coma Scale 13-15) within 24 hours of injury, to aid in determining the need for head CT imaging. Currently, CT head imaging for adults with suspected mild TBI is obtained based on clinicians' usual practice patterns and beliefs about patient expectations. Prior research has demonstrated the blood TBI test may reduce unnecessary CT scans by up to 40%, however the impact on head CT ordering has not yet been studied prospectively. It is important to understand the extent to which a negative TBI biomarker result empowers a clinician to cancel a previously ordered head CT. Given that adult patients with mild TBI often present to EDs, which have access to CT scanners, this is a key setting to assess real-world impact of the i-STAT TBI test on CT head utilization.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Stroke, Skull Fracture, Multiple Sclerosis, Others
450 Participants Needed
Non-Invasive Brain Stimulation for Traumatic Brain Injury
Minneapolis, MinnesotaThis is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe TBI, Visual Impairment, Others
30 Participants Needed
Airway Splint for Bronchomalacia
Ann Arbor, MichiganThe purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children.
The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 3
Sex:All
Key Eligibility Criteria
Disqualifiers:Tracheal Stenosis, Single-lung Anatomy, Others
35 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
Virtual Reality Training for Traumatic Brain Injury
West Orange, New JerseyProblems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury.
The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Seizures, Heart Disease, Spinal Cord Injury, Others
135 Participants Needed
iTBS for Healthy Individuals
Toronto, OntarioThe goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on brain plasticity in healthy, right-handed individuals aged 18 to 50 years. Brain plasticity is the brain's ability to change through growth or reorganization. iTBS is a form of transcranial magnetic stimulation (TMS), where magnetic pulses are applied to the scalp using a coil. These pulses pass through the scalp, and can alter brain activity in the area underneath the coil. Based on previous research conducted in animals and humans, researchers believe that iTBS can strengthen the connections between cells in the brain, leading to improved brain plasticity.
This trial will compare the effects of the compressed iTBS (iTBS-c) protocol, which is commonly used to treat depression, and the spaced iTBS (iTBS-s) protocol. Researchers want to find out which protocol is better able to produce changes in brain plasticity. Sham iTBS (iTBS-sh) will be used as a control to make the results of the study more reliable.
Participants will complete 5 study visits within the span of 3 months, including:
* Screening assessments to determine eligibility (Visit 1);
* Calibration iTBS session (Visit 2) to assess tolerability of brain stimulation;
* Three experimental iTBS sessions (iTBS-s, iTBS-c, and iTBS-sh) in a randomized order (Visits 3-5), each separated by at least 72 hours. During each session, the study team will stimulate the motor cortex and record the muscle activity of your hand to measure changes in brain plasticity.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Age, DSM-5 Diagnosis, Neurological Conditions, Others
Must Not Be Taking:Psychotropic Medications
30 Participants Needed
Patients with memory and cognitive deficits following TBI that do not respond to conventional treatments experience a decrease in quality of life. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress has been made in altering the natural history of the condition or its outcome.
This study would explore whether a surgical therapy is safe and potentially effective in patients who develop refractory memory and cognitive deficits following TBI. Preclinical studies suggest that DBS may improve memory deficits in TBI models. Moreover, DBS delivered to the fornix has shown promising clinical results in patients with Alzheimer's disease. The main mechanism for the improvements induced by DBS in memory tests is the development of multiple forms of plasticity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Epilepsy, Alzheimer's, Pregnancy, Others
10 Participants Needed
Robotic Balance Training + Brain Stimulation for Traumatic Brain Injury
West Orange, New JerseyOur proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.
The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.
This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:All
45 Participants Needed
Theta Burst Stimulation for Depression and Autism
Cincinnati, OhioEvaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 26
Sex:All
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Epilepsy, Others
Must Not Be Taking:Anticonvulsants, Barbiturates, Lithium, Benzodiazepines
24 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
Vagal Nerve Stimulation for Traumatic Brain Injury
Chicago, IllinoisThe purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
60 Participants Needed
Page 1 of 5+
Frequently Asked Questions
How much do Tb 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 Tb 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 Tb 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 Tb 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 Tb 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 Tb clinical trials ?
Most recently, we added BRILLIANT Platform for Brain Injury, Aerobic Exercise for Head Injuries and Trauma-Informed Intervention for Substance Use Disorders to the Power online platform.