Traumatic Brain Injury (TBI)

6

Review clinical trials related to Traumatic Brain Injury (TBI). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Allopregnanolone in Chronic Complex Traumatic Brain Injury

This 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.

Participants needed: 132
Trial details
Phase: Phase 2Age: 21-62Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

21-62 years of age, any ethnic group, either sex [+16]

Participants with current suicidal or homicidal ideation necessitating clinical... [+10]

Status: Recruiting

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities. Participants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches. The purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available. This study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.

Participants needed: 100
Trial details
Age: 4-12Biological sex: AllType: ObservationalSponsor: Healing Hope InternationalUpdated: Mar 25, 2026Locations: 1
Eligibility criteria

Pediatric participants between approximately 4 and 12 years of age at the time o... [+17]

Medical instability or acute medical condition that would prevent safe participa... [+5]

Status: Not yet recruiting

Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD

This randomized clinical trial will enroll 100 Veteran-family/friend dyads to test the efficacy of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomized to the CALM group will demonstrate: * Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction. * Significantly larger improvements in social and adaptive functioning including less aggression. * Significantly larger reduction in PTSD symptoms and suicidal ideation. The study targets Veterans who experience difficulties with anger and impulsivity due to TBI and PTSD. These issues are common, with up to 38% of Veterans with TBI also having PTSD. These conditions often make it challenging for Veterans to control their emotions and interact successfully in social and work settings. Our research will test the CALM (Cognitive Applications for Life Management) mobile app, which helps Veterans manage their goals, remember important tasks, and improve their attention. Initial tests of CALM have shown it can reduce levels of anger and related issues in Veterans. The investigators will conduct a study with 100 pairings of Veterans and a family member or friend. These pairs will be randomly assigned to one of two groups: one using the CALM mobile platform and the other receiving brain health education. Both groups will use their assigned intervention for three months and will receive support through videoconference calls at the beginning, middle, and end of the program.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Mar 13, 2026Locations: 1
Eligibility criteria

U.S. Veteran who served in one of the military branches (Army, Navy, Marines, Ai... [+11]

Does not own a smartphone. [+1]

Status: Recruiting

Hemodynamic ABI Monitor

The goal of this observational study is to explore the relationship of heart function with the course and outcomes after traumatic brain injuries and nontraumatic intracerebral hemorrhage. The goal is to explore association between routinely collected hemodynamic and brain monitoring data. Participants already taking intervention A as part of their regular medical care and the investigators will follow up with participants 6 months after discharging the hospital.

Participants needed: 50
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: University of ChicagoUpdated: Mar 4, 2026Locations: 1Duration: 6 Months
Eligibility criteria

Admitted to the University of Chicago Medical Center Neurocritical Care Unit [+7]

Status: Recruiting

Low-Tech Treatments for Obstructive Sleep Apnea

The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.

Participants needed: 60
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Uniformed Services University of the Health SciencesUpdated: Feb 17, 2026Locations: 1
Eligibility criteria

New diagnosis of OSA (AHI, ≥ 5) or failure of first-line OSA treatment; [+3]

Current use of OSA treatment; [+2]

Status: Not yet recruiting

Spinal Stimulation and Gait Training to Improve Mobility in TBI

The 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.

Participants needed: 30
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Kessler FoundationUpdated: Sep 2, 2025Locations: 2
Eligibility criteria

Have weakness on at least one side of my body. [+12]

Have must have not had physical or occupational therapy or treatment for a balan... [+22]