Brain Injuries, Traumatic

17

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

Condition / disease
Location
Status: Recruiting

Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma

Minor head trauma is one of the most frequent reasons for paediatric emergency department visits worldwide. The PECARN (Paediatric Emergency Care Applied Research Network) clinical decision rule stratifies children with minor head trauma into low-, intermediate-, and high-risk categories for clinically important traumatic brain injury (ciTBI) and provides evidence-based guidance on computed tomography (CT) ordering. Despite its high diagnostic accuracy, real-world CT utilisation frequently diverges from PECARN recommendations. Non-clinical family-level factors - including socio-cultural characteristics and health literacy - may drive part of this divergence, particularly through their influence on whether families explicitly request CT imaging. This prospective observational cohort study will enrol 200 children with minor head trauma presenting to the emergency department of SBU Bursa Yuksek Ihtisas EAH, Bursa, Turkey. The primary aim is to determine whether family socio-cultural level (composite index incorporating education, occupation, income, and housing; scored 0-10) and health literacy (Newest Vital Sign-Turkish, NVS-TR) independently predict parental demand for CT imaging. Secondary aims include determining whether parental CT demand and family socio-cultural characteristics predict CT ordering by the treating physician, describing PECARN algorithm adherence patterns in this setting, and examining parental health-seeking behaviour at 7-day telephone follow-up.

Participants needed: 200
Trial details
Age: Up to 17Biological sex: AllType: ObservationalSponsor: Bursa Yuksek Ihtisas Training and Research HospitalUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Age less than 18 years at time of emergency department presentation [+3]

GCS score 13 or less at presentation (moderate or severe head injury) [+9]

Status: Not yet recruiting

Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury

The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI Evidence Based Intervention (EBI) in a real world setting at a CDC-recognized site

Participants needed: 70
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Baylor Research InstituteUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

18-80 years of age [+3]

Contraindications to physical activity [+5]

Status: Recruiting

Automated Robotic TCD in Traumatic Brain Injury

This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Virginia Commonwealth UniversityUpdated: Jun 3, 2026Locations: 3
Eligibility criteria

Adults ≥18 [+4]

Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-po... [+5]

Status: Recruiting

Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function

This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.

Participants needed: 300
Trial details
Age: 18-89Biological sex: AllType: InterventionalSponsor: Oregon Health and Science UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

Male and female; any race; 18-89 years of age. [+20]

Status: Recruiting

mTBI Identification and Monitoring Through Retinal Scanning

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.

Participants needed: 60
Trial details
Age: 18-45Biological sex: AllType: ObservationalSponsor: Rebiscan, Inc.Updated: May 20, 2026Locations: 1
Eligibility criteria

Age 18-45 years [+5]

Glasgow Coma Scale score equal to or less than 13 at the time of study enrollmen... [+16]

Status: Recruiting

Buspirone and Melatonin for Depression Following Traumatic Brain Injury

Traumatic brain injuries (TBIs) are common. Post-TBI depression is associated with anxiety, aggression, fatigue, distractibility, anger, irritability, and rumination. The current research group conducted a pilot clinical trial, which investigated the novel treatment combination of buspirone and melatonin (B+MEL) in outpatients with clinical depression. Compared to placebo, B+MEL was associated with a significant improvement in depressive symptoms. Depression following TBI may be different from clinical depression. The B+MEL combination has never been studied in patients with post-TBI depression. The B+MEL has shown promise in ameliorating cognitive difficulties in people with depression. Because cognitive problems are typical in people with post-TBI depression, we plan to measure the effect of the B+MEL combination on cognitive ability in post-TBI depression. Additionally, we are interested in measuring functional magnetic resonance imaging changes before and after treatment with B+MEL in order to gain insight into the brain mechanisms of our hypothesized clinical symptom changes. The goals of the proposed pilot research project are to assess changes in symptoms in patients with post-TBI depression following Buspirone + Melatonin combination (B+MEL), and the corresponding brain mechanisms underlying these hypothesized changes by measuring: 1) depressive symptoms; 2) cognitive symptoms; 3) functional magnetic resonance imaging.

Participants needed: 10
Trial details
Phase: Phase 4Age: 18-64Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: May 6, 2026Locations: 2
Eligibility criteria

Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more... [+8]

History of neurological disorder (e.g., stroke, epilepsy, multiple sclerosis, HI... [+11]

Status: Recruiting

Mild TBI Assessment & Rehabilitation

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

Participants needed: 65
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: May 6, 2026Locations: 2
Eligibility criteria

Ages 18+ [+9]

A history of moderate or severe TBI [+15]

Status: Not yet recruiting

Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

This is a prospective observational cohort study of adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The study acquires multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) from standard-of-care monitoring, Brain4Care (B4C) noninvasive intracranial dynamics monitoring, and near-infrared spectroscopy (NIRS)-derived cerebral autoregulation (CA) indices where NIRS is already in clinical use - and links these data to bedside physiologic, medication, diagnostic, and clinical outcome variables during standard care. No alteration of clinical management occurs. The study prioritizes aneurysmal subarachnoid hemorrhage (aSAH) patients to characterize the natural history of noninvasive CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14) and provides preliminary data for subsequent interventional study design.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of Texas Southwestern Medical CenterUpdated: May 11, 2026Locations: 1
Eligibility criteria

Age 18 years or older [+3]

Age younger than 18 years [+7]

Status: Recruiting

Brain Injury Education and Outpatient Navigation-1stBIEN

Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups.

Participants needed: 300
Trial details
Age: 3+Biological sex: AllType: InterventionalSponsor: Seattle Children's HospitalUpdated: Jan 13, 2026Locations: 6
Eligibility criteria

Children 3 to 17 years of age, [+6]

Prior neurological deficits, [+4]

Status: Not yet recruiting

Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study

Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.

Participants needed: 2,000
Trial details
Phase: Phase 3Age: 0-17Biological sex: AllType: InterventionalSponsor: Daniel Nishijima, MD, MASUpdated: Dec 15, 2025
Eligibility criteria

Less than 18 years old AND [+12]

Unable to administer study drug within 3 hours of traumatic event [+15]

Status: Recruiting

Morning Bright Light to Improve Sleep Quality in Veterans

One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Portland VA Medical CenterUpdated: Nov 14, 2025Locations: 1
Eligibility criteria

Veterans

History of bipolar disorder [+4]

Status: Recruiting

Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)

The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Participants needed: 160
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: United States Naval Medical Center, San DiegoUpdated: Nov 12, 2025Locations: 2
Eligibility criteria

Active-Duty Service Members. [+6]

Presence of a medical, psychiatric, physical or non-physical disease, disorder,... [+8]

Status: Recruiting

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

Our 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.

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

The Value of Combined Detection of Different Blood Biomarkers in the Diagnosis and Treatments of Traumatic Brain Injury

TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, and has increasingly become the focus of the international scientific research community. Exploring blood-based biomarkers has potential clinical value, which can greatly help clinicians to evaluate patients' conditions and develop reasonable plans, and then improve the clinical management and treatment of patients with craniocerebral trauma. Further research work is needed to be done to identify the most effective and efficient biomarker or combination marker strategies for integration into clinical treatment.

Participants needed: 80
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: First Affiliated Hospital Xi'an Jiaotong UniversityUpdated: Mar 3, 2025
Eligibility criteria

Age: 18-65 years old [+4]

With a history of neurological or psychiatric disorders [+4]

Status: Recruiting

Online Memory Intervention for Individuals with Traumatic Brain Injury

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.

Participants needed: 84
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: Toronto Rehabilitation InstituteUpdated: Nov 25, 2024Locations: 1
Eligibility criteria

acute care diagnosis of m-sTBI [+6]

neurological disorder other than TBI (e.g., dementia, stroke) [+5]

Status: Recruiting

Ketamine in Acute Brain Injury Patients.

Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice. The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.

Participants needed: 100
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Geert Meyfroidt, MD, PhDUpdated: Aug 22, 2024Locations: 8
Eligibility criteria

Traumatic brain injury patients [+4]

Known pregnancy and/or lactation [+8]

Status: Recruiting

Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed. The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department. The main research question is: \- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes? Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group. The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records \>1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (\>6 months).

Participants needed: 5,300
Trial details
Age: Up to 17Biological sex: AllType: ObservationalSponsor: Halmstad County HospitalUpdated: Feb 28, 2024Locations: 16Duration: 4 Months
Eligibility criteria

Age <18 years. [+3]

Patient and/or guardian does not wish to participate in the study. [+4]