TBI

11

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

Condition / disease
Location
Status: Recruiting

Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury

Cognitive impairment after moderate to severe traumatic brain injury (msTBI) not only significantly affects the quality of life in individuals with msTBI, but also increases the possibility of late-life dementia. The goal of this study is to determine whether acute (\< 1 week) cerebrovascular injury and its recovery within the first year postinjury measured by cerebral autoregulation and brain perfusion are associated with cognitive outcome at 12 months after msTBI. The results from this study will improve our understanding of cerebrovascular contributions to cognitive decline related to TBI and provide critical data to inform the development of strategies based on vascular mechanisms to improve cognition and prevent neurodegeneration after msTBI.

Participants needed: 130
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: University of Texas Southwestern Medical CenterUpdated: Jul 2, 2026Locations: 3
Eligibility criteria

Documented/Verified TBI (ACRM Criteria) (eg, motor vehicle (MV) occupant, MV ped... [+8]

Age greater or less than the range 18-80 years [+12]

Status: Not yet recruiting

INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention

The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters with a history of traumatic brain injury, post-traumatic stress disorder, or chronic operational stress commonly report disrupted sleep accompanied by manifestations of nocturnal sympathetic activation such as diaphoresis, palpitations, hyperarousal, and nightmares. These symptoms erode sleep quality, reduce cognitive performance, and undermine psychological resilience and operational readiness. Insomnia is two to three times more common in military populations than in civilians, and both TBI and PTSD independently elevate the risk for dysregulated autonomic tone. Excessive sympathetic activity during REM sleep disrupts the normally quiescent locus coeruleus state required for adaptive emotional processing and may contribute to the genesis of nightmares. Excessive sympathetic tone may also interfere with deep NREM-dependent glymphatic clearance, a recently discovered mechanism that supports cognitive restoration and metabolic waste removal. Yet, no study has comprehensively linked these physiological processes in warfighters or evaluated whether wearable-derived autonomic measures can meaningfully stratify insomnia phenotypes. The INSIGHT protocol addresses this gap through a two-phase design integrating multimodal biomarker collection, wearable technology validation, advanced imaging, and a randomized controlled intervention. Phase 1 enrolls 250 participants (50 healthy controls and 200 poor sleepers with or without PTSD and TBI) who undergo structured screening, cognitive testing, and detailed baseline assessments before completing a 2-week at-home data collection period. During this period, participants wear a suite of devices, including EEG headbands, ECG patches, PPG-based sensors, accelerometry rings, blood pressure devices, temperature sensors, and smartwatches, to capture autonomic activity, sleep architecture, cardiovascular and respiratory variability, movement, sudomotor activity, and circadian body temperature patterns. Ecological momentary assessments administered three times daily track fluctuations in sleep quality, mood, PTSD symptoms, and daytime functioning, while urine samples collected on the final three days allow for biochemical analysis of hormonal and sympathetic biomarkers. After the at-home period, all participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures. A subset of participants also completes an optional overnight MRI with simultaneous EEG following controlled sleep deprivation, enabling state-of-the-art imaging of human glymphatic activity using the MAGNUS MRI platform. This optional visit provides unprecedented insight into how TBI, PTSD, and insomnia alter the physiology of sleep-dependent brain fluid dynamics. In Phase 2, all poor sleepers enter a double-blind, sham-controlled, 30-day randomized trial testing the therapeutic potential of the NightWare smartwatch. NightWare detects sympathetic surges during sleep through heart rate elevations and movement patterns and delivers brief haptic vibrations aimed at interrupting escalating autonomic arousal. Although originally cleared for nightmare treatment, its mechanism is well suited for SNH-related insomnia more broadly. Participants use the device daily while continuing EMA surveys, wearable monitoring, and cognitive assessments, generating rich physiological and behavioral data throughout the intervention. The primary goal is to determine whether reducing nocturnal sympathetic spikes leads to measurable improvements in sleep quality, autonomic stability, daytime functioning, and symptom burden. In parallel, Phase 2 data enable development of the Multi-Organ Autonomic Index of Sleep, an integrated biomarker model that combines neurological, cardiovascular, respiratory, and dermal signals to predict treatment response and classify insomnia subtypes. The INSIGHT study will produce the most comprehensive dataset to date linking autonomic physiology, glymphatic function, sleep architecture, wearable-derived biomarkers, cognition, and clinical outcomes in warfighters. By identifying physiological signatures of sympathetic hyperarousal and determining whether a non-pharmacological wearable intervention can meaningfully improve sleep, INSIGHT directly supports Department of Defense priorities to enhance readiness, resilience, and long-term neurological health in service members. Wearable tools capable of monitoring and improving sleep outside the laboratory have the potential to transform both clinical care and operational performance, offering scalable and accessible approaches to restoring sleep and optimizing recovery.

Participants needed: 180
Trial details
Age: 18-62Biological sex: AllType: InterventionalSponsor: Uniformed Services University of the Health SciencesUpdated: Apr 28, 2026Locations: 2
Eligibility criteria

Defense Enrollment Eligibility Reporting System (DEERS) Eligible [+5]

Use of alpha or beta-receptor active medications or prescribed sleep aids in the... [+21]

Status: Recruiting

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

Participants needed: 1,000
Trial details
Age: 1-18Biological sex: AllType: ObservationalSponsor: Children's Hospital Los AngelesUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Individuals who are able to tolerate an MRI. [+2]

Presence of an MRI-incompatible device or implant (e.g. pacemakers, stents) [+3]

Status: Not yet recruiting

Comparing Approaches to Helping People With Chronic Traumatic Brain Injury Manage Their Health Care

The goal of this double-masked, randomized control trial is to learn about the potential benefits of two different strategies at helping people with traumatic brain injury who see a brain injury physician be more engaged in their healthcare and feel more confident in managing their health. The main questions it aims to answer are: * When comparing the two strategies, which will result in high participant-reported health empowerment assessed approximately 7 - 21 days of completing the approach? * When comparing the two strategies, which will result in high participant-reported health engagement assessed approximately 7 - 21 days of completing the approach? Participants will: * complete baseline assessments about their health, daily activities, and their attitudes about healthcare and their treatment. These will be done over the phone and/or online survey. * have one virtual session with a health professional to discuss their health and wellness. * 7-21 days after the session with a health professional, participants will complete an online survey about their attitudes about healthcare and their treatment. * Some participants may be invited to complete an additional interview about their study participation around 3 months after their session with the health professional.

Participants needed: 142
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Indiana UniversityUpdated: Mar 19, 2026Locations: 1
Eligibility criteria

community dwelling adult (>18 years at enrollment) [+9]

non-community dwelling

Status: Recruiting

A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.

Participants needed: 120
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Mar 6, 2026Locations: 1
Eligibility criteria

Recently transitioned Veterans within three years of separation from military se... [+3]

Active psychosis [+5]

Status: Not yet recruiting

Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments

This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.

Participants needed: 120
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Motion Informatics LTDUpdated: Feb 11, 2026Locations: 1
Eligibility criteria

Adult men and women aged 18-80 years. [+5]

Presence of contraindications to electrical stimulation (ES), including implante... [+7]

Status: Recruiting

Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond

For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.

Participants needed: 120
Trial details
Age: 21-60Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Nov 17, 2025Locations: 1
Eligibility criteria

Post 9/11 Veterans [+2]

Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilli... [+7]

Status: Recruiting

NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury

Our proposed study, \&#34;NEUROBALANCE,\&#34; 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.

Participants needed: 45
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Kessler FoundationUpdated: Aug 6, 2025Locations: 1
Eligibility criteria

Aged between 18-75 years [+6]

Currently undergoing any regular physical therapy program or research studies fo... [+8]

Status: Not yet recruiting

Reduced-dose Conditioning Regimen Containing TBI in HSCT Treating Elderly Patients With Aplastic Anemia

The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg / kg-6d ; fludarabine 30mg / m2 / d-5 \~ -1d ; cyclophosphamide 25-30mg / kg / d-5 \~ -2d ; ATG ( rabbit ) 2 mg / kg / d-5 \~ -1d.

Participants needed: 20
Trial details
Phase: Phase 2Age: 50+Biological sex: AllType: InterventionalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Jan 10, 2025
Eligibility criteria

( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, sever...

( 1 ) Patients who underwent more than one time of transplantation before enroll...

Status: Recruiting

Longitudinal Cognitive Assessment by BoCA

The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.

Participants needed: 10,000
Trial details
Age: 50+Biological sex: AllType: ObservationalSponsor: Alzheimer's Light LLCUpdated: Aug 1, 2024Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Understanding Patient Engagement Trends in TBI Clinical Research

Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation. The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Power Life Sciences Inc.Updated: Mar 1, 2024Locations: 1
Eligibility criteria

Ability to understand and the willingness to sign a written informed consent doc... [+2]

Enrolled in another research study [+2]