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125 Traumatic Injury Trials Near You
Power is an online platform that helps thousands of Traumatic Injury patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerProblem-Solving Training for Concussion
Buffalo, New York
This trial is testing a new treatment called PST-Concussion to help Veterans with mild traumatic brain injury manage their symptoms. The study aims to see if this treatment can reduce psychological distress and improve overall functioning. If successful, it could offer a practical way to support Veterans' recovery. Problem-solving treatment (PST) has been previously explored as a method to help service members with mild traumatic brain injury manage their symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Moderate To Severe TBI, Psychotic Disorder, Others
134 Participants Needed
Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness
Mississauga, Ontario
The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:8+
Key Eligibility Criteria
Disqualifiers:Wound Management, Insensate Feet, Ulcerations, First-time AFO Users
50 Participants Needed
Caregiver Counseling for Childhood Traumatic Injury
Winston-Salem, North Carolina
The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 6
Key Eligibility Criteria
Disqualifiers:Cognitive Deficits, Psychotic Symptoms, Others
24 Participants Needed
Collaborative Care for Post-Traumatic Epilepsy
Winston-Salem, North Carolina
This trial is testing whether regular phone calls from a healthcare team can improve the quality of life for adults with post-traumatic epilepsy and anxiety or depression. The study will observe the effects over several months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Suicide Attempt, Alcohol Abuse, Others
60 Participants Needed
Levetiracetam + Lacosamide for Seizure Prevention
Winston-Salem, North Carolina
The 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:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Seizures, Alcohol Withdrawal, Others
Must Be Taking:Seizure Prophylaxis
600 Participants Needed
NRF for Traumatic Brain Injury
Carlisle, Pennsylvania
The purpose of this study is to evaluate the effectiveness of NeuroResource Facilitation, a novel/innovative intervention, in reducing recidivism in offenders with brain injury (BI).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Non-English Speaking, Under 18
1032 Participants Needed
Online Memory Intervention for Traumatic Brain Injury
Toronto, Ontario
This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and brain health in individuals who have sustained moderate-severe traumatic brain injury.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Neurodevelopmental Disorder, Systemic Comorbidities, Aphasia, Others
84 Participants Needed
Biofeedback Training for Hemianopia
Toronto, Ontario
This trial is testing Biofeedback Training (BT) for patients with vision loss on one side due to brain injury. BT uses real-time feedback like sounds or lights to help patients improve their eye movements. This can help them see better by bringing visual information from their blind side into their seeing side. Biofeedback has been explored for various eye conditions and visual impairments, showing potential in improving visual functions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Ocular Diseases, Media Opacity, Others
32 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
Graded Exposure Therapy for Concussion
Toronto, Ontario
This trial tests a therapy called Graded Exposure Therapy for adults who have ongoing symptoms after a concussion. The therapy helps them gradually face activities they fear, which can improve their recovery. The study aims to see if this approach is more effective.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Pregnancy, Others
Must Not Be Taking:Beta Blockers, Calcium Channel Blockers
220 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
Key Eligibility Criteria
Disqualifiers:Epilepsy, Alzheimer's, Pregnancy, Others
10 Participants Needed
CBT-I vs. MBTI for TBI-Related Insomnia
Bethesda, Maryland
This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Diseases, Sleep Apnea, Others
360 Participants Needed
tDCS + Physiotherapy for Acquired Brain Injury
Toronto, Ontario
This study will evaluate the feasibility of transcranial direct current stimulation (tDCS) as an adjunct to an outpatient motor skills-based physiotherapy intervention for children and youth with acquired brain injury. Up to 10 children (age 5-18 years) with childhood onset stroke or traumatic brain injury will be randomly allocated to receive active or sham anodal tDCS immediately prior to the physiotherapy session. These sessions will occur twice weekly for a total of 10 sessions. Assessment of gross motor outcome measures will occur immediately before and after the combined tDCS and physiotherapy treatment protocol. The preliminary treatment effect between the two treatment groups will be compared and other feasibility indicators will be evaluated.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:5 - 18
Key Eligibility Criteria
Disqualifiers:Not Listed
10 Participants Needed
RTM vs PE for PTSD
Bethesda, Maryland
Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (\~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base.
The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can be conducted either in person or via secure video conferencing.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Not Listed
94 Participants Needed
rTMS for TBI-related Depression
Bethesda, Maryland
The 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
Key Eligibility Criteria
Disqualifiers:Seizure History, Bipolar, Schizophrenia, Others
Must Be Taking:Psychotropic Medications
198 Participants Needed
Educational Video for Concussion
Falls Church, Virginia
This study will develop and validate a new ED/Urgent Care discharge educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:13 - 21
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Previous MTBI, Others
70 Participants Needed
Digital Therapeutic for Depression After Traumatic Brain Injury
Bethesda, Maryland
This trial tests a mobile app designed to help military service members and veterans with mild traumatic brain injury reduce their depression. The app helps users change negative thoughts and behaviors to improve their mood. This type of therapy has been shown to be effective for various mental health issues, including depression, and can be delivered through different methods such as mobile apps.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
113 Participants Needed
Cryoneurolysis for Rib Fractures
Toronto, Ontario
Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life.
A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Substance Use, Others
Must Not Be Taking:Opioids
24 Participants Needed
IVE Therapy vs Traditional Rehabilitation for Concussion
Fort Belvoir, Virginia
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Ophthalmic, Neuromuscular, Cardiovascular, Others
48 Participants Needed
Trauma Resilience and Recovery Program for PTSD
Washington, Virginia
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16+
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Active Psychosis, Substance Abuse, Others
350 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"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
Brief Prolonged Exposure Therapy for Post-Traumatic Stress Disorder
Milwaukee, Wisconsin
The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Police Custody, Non-English, Cognitive Impairment, Suicidal, Psychosis
300 Participants Needed
Education Strategies for Concussions
Milwaukee, Wisconsin
The 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
Key Eligibility Criteria
Disqualifiers:Psychiatric Hold, Dementia, Terminal Cancer, Others
5831 Participants Needed
MEMI App for Traumatic Brain Injury
Nashville, Tennessee
This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
40 Participants Needed
Community Health Services for Traumatic Brain Injury
Richmond, Virginia
TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Severe Cognitive Impairment
126 Participants Needed
Virtual Reality Exercises for Traumatic Brain Injury
Baltimore, Maryland
Traumatic brain injury (TBI) is a major public health concern, particularly among older adults (OAs) ≥ 65 years of age. Each year in the United States, TBI results in over 600,000 emergency department visits and hospitalizations among OAs. Mild TBI (mTBI) accounts for 80% of all TBI in OAs and is quite understudied in this rapidly growing population. mTBI, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. Cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following TBI. Virtual reality (VR) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (NRM) to improve cognitive decline post TBI. Not only can VR provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. Yet, despite the promise of cognitive rehabilitation using VR among OAs, very few studies to date have assessed the efficacy of VR cognitive rehabilitation in TBI. The aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in OAs with mTBI. The hypothesis is that The use of VR mediated cognitive exercises post mTBI will be associated with improved executive function at 6-weeks post-randomization compared to the control group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Seizure Disorders, Others
70 Participants Needed
External Cranial Prosthesis for Trephined Syndrome
Baltimore, Maryland
Patients 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:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Bilateral Hemicraniectomy, Hydrocephalus, Others
72 Participants Needed
Metabolic MRI with Hyperpolarized Pyruvate for Traumatic Brain Injury
Baltimore, Maryland
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI.
The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study.
Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Inability To Undergo MRI, Others
15 Participants Needed
Digital Decision Aid + Communication Tool for Hemorrhagic Stroke
Baltimore, Maryland
The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English, Illiterate, Early Death, Others
50 Participants Needed
Multiple Treatments for Brain Injury
Baltimore, Maryland
The 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
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Epilepsy, Others
Must Not Be Taking:SSRIs
40 Participants Needed
Face Transplant for Facial Disfigurement
Baltimore, Maryland
Background: The human face is critically important for breathing, eating, seeing, and speaking/ communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although current surgical advancements can somewhat restore facial defects, this process often requires many operations and the resulting face only resembles the human face. To date, over 20 face transplants have been performed with highly encouraging functional and aesthetic results, but widespread clinical use has been limited due to the adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of face transplantation.
Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face transplantation as a safe and effective reconstructive treatment for devastating injuries/ defects by minimizing maintenance immunosuppression therapy in face transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 15 full or partial human face transplants employing this novel protocol.
Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term, high-dose, multi-drug immunosuppression.
Significance of Research: Face transplantation could help injured individuals recover functionality, self-esteem, and the ability to reintegrate into family and social life as "whole" individuals. This protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this life-enhancing procedure and enabling a wider clinical application of face transplantation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, Malignancy, Others
15 Participants Needed
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Frequently Asked Questions
How much do Traumatic Injury clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Traumatic Injury clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Traumatic Injury trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Traumatic Injury is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Traumatic Injury medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Traumatic Injury clinical trials?
Most recently, we added Multiple Treatments for Brain Injury, Cervical Rehabilitation for Concussion Symptoms and Neck Pain and Aerobic Exercise for Head Injuries to the Power online platform.
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