TBI (Traumatic Brain Injury)

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

Condition / disease
Location
Status: Not yet recruiting

Nanopulse Laser Therapy

The purpose of this study is to evaluate the safety and effectiveness of a novel noninvasive therapy, Nanopulse Laser Therapy (NPLT), to improve recovery following traumatic brain injury (TBI).

Participants needed: 30
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: The University of Texas Medical Branch, GalvestonUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Adults aged 18 years or older at the time of enrollment [+4]

Patients younger than 18 years of age [+5]

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

Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury

this study aims to assess the ability of fibrinogen-to-albumin ratio to predict the development of Acute respiratory distress syndrome in traumatic brain injury patients.

Participants needed: 350
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Tanta UniversityUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

Patients ≥ 18 years admitted to the ICU with traumatic Brain Injury [+4]

Preexisting advanced chronic liver disease, nephrotic syndrome, or protein-losin... [+7]

Status: Recruiting

fNIRS for Disorders of Consciousness

The goal of this observational study is to learn whether functional near-infrared spectroscopy (fNIRS) can measure brain activity in healthy adults and in people with disorders of consciousness (DoC) in the neuro-intensive care unit (Neuro-ICU). DoC include conditions such as coma and minimally conscious state that occur after severe brain injury. These conditions make it difficult to assess a person's level of awareness because many clinical tests rely on observable behaviors such as speaking or moving, which are commonly impaired after brain injury. The main questions the study aims to answer are: * Can fNIRS detect changes in brain activity in healthy adults when they receive sensory stimulation or perform mental tasks? * Can the same fNIRS protocol be used in patients with disorders of consciousness in the Neuro-ICU to measure brain responses and determine whether the method is feasible in this clinical setting? The investigators will first study healthy adult volunteers to establish baseline brain responses and determine which tasks produce the most reliable signals. The protocol will then be applied to patients with disorders of consciousness admitted to the Neuro-ICU. Participants will take part in a single research session lasting about 30 to 45 minutes while wearing the lightweight fNIRS headband that measures brain oxygen levels using near-infrared light. During the session, participants will: * Wear a non-invasive fNIRS headband placed on the forehead * Receive gentle sensory stimulation (for example, compression devices on the legs or hands) * Listen to sounds or spoken sentences * Perform guided mental tasks such as imagining walking through their home or imagining moving a limb The study does not test a treatment and will not change medical care. The goal is to determine whether fNIRS can safely and reliably measure brain activity at the bedside and provide preliminary information that may help guide future research on improving the assessment of consciousness after brain injury.

Participants needed: 55
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of California, Los AngelesUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Age 18 years or older [+9]

Known baseline hearing impairment without available hearing aids [+7]

Status: Not yet recruiting

Feasibility of SUPPORT-TBI

Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others. They often lose friendships, become isolated, and have strained family relationships. This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan. The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions. They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience. This study will determine whether the program is practical to deliver. We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile. Based on what they learn, the investigators will refine this program before testing it on a larger scale. If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Washington University School of MedicineUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Age 18 or older [+4]

Insufficient English language fluency [+3]

Status: Not yet recruiting

Neuro-Inflammation in Extremity Trauma: Risk Verification in Elbow Trauma: The NERVE Study

The primary goal of this proposal is to improve the understanding of the mechanisms causing persistent pain and disability in elbow fracture patients and their associated functional limitations. The specific objectives are as follows for elbow fractures: 1\) To describe NI mechanisms using biomarkers; 2) To identify factors related to increased NI biomarkers level; 3) To describe the associations between NI and outcomes; 4) To use these findings to refine a larger fully powered prognostic cohort study Hypotheses 1. Level of neuro-inflammation (NI) biomarkers\* will be significantly higher in patients presenting with both elbow fracture and CNS injury or PNI. 2. Consumption of opioid in mg of morphine equivalent will be higher in patients with a higher level of NI biomarkers. 3. Function, assessed by validated joint and limb specific functional questionnaires and QoL will be worse in patients with a higher level of NI biomarkers. 4. Chronic pain at 3 months will be higher (McGill Pain questionnaire V2, Neuropathic pain questionnaire, NPRS) in patients with a higher level of NI biomarkers. 5. Duration of tourniquet use and nerve dissection will be correlated to elbow fracture outcome with a higher level of NI biomarkers. * Target biomarkers based on preliminary study will include, but not be limited to: TNFa, IL6, Substance P, IL-1B, TREM-2, IL-16, CCL22, VEGF-a, BMPs (table 1).

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Université de MontréalUpdated: Apr 28, 2026
Eligibility criteria

Adults 18 years or older with an acute elbow fracture and/or dislocation less th... [+1]

Patient with a history of ipsilateral upper limb trauma or pathology, neurologic... [+7]

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

ENGAGE-TBI Feasibility Study

This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Washington University School of MedicineUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

at least 18 years old [+3]

insufficient English language fluency to participate in the group intervention [+3]

Status: Recruiting

Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.

The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.

Participants needed: 760
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Nantes University HospitalUpdated: Apr 29, 2026Locations: 23
Eligibility criteria

Patient admitted to intensive care unit [+5]

Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despi... [+10]

Status: Recruiting

Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients

To evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assaf-Harofeh Medical CenterUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

Diagnosed with traumatic brain injury [+3]

An inability to perform a neurocognitive computerized test. [+4]

Status: Not yet recruiting

Nanopulse Laser Therapy

The purpose of this study is to evaluate the safety and effectiveness of a novel noninvasive therapy, Nanopulse Laser Therapy (NPLT), to improve recovery following traumatic brain injury (TBI).

Participants needed: 30
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: The University of Texas Medical Branch, GalvestonUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

Adults aged 18 years or older at the time of enrollment [+4]

Patients younger than 18 years of age [+5]

Status: Recruiting

Stimulating After Recovery From Traumatic Brain Injury

This 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.

Participants needed: 30
Trial details
Phase: Early Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Apr 7, 2026Locations: 1
Eligibility criteria

Adults 18 years and older [+8]

Open wound on scalp [+12]

Status: Recruiting

Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment

Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for refugees with traumatic brain injury (TBI). They're checking if this program is practical and if people find it helpful. The study will have two groups. Participants will complete a first questionnaire and then be assigned to a group by chance. One group will participate in the program immediately and then answer the second questionnaire (approximately 3 months after the first questionnaire they did). Then they will wait and then answer the third and final questionnaire approximately 6 months after the first one. The second group will wait and answer the second questionnaire approximately 3 months after the first one. Then they will receive the program and answer the third and final questionnaire (approximately 6 months after the first one they did.)

Participants needed: 50
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Mar 11, 2026Locations: 1
Eligibility criteria

Identify as an asylum seeker, refugee or have been granted asylum or other form... [+6]

Participation in cognitive rehabilitation treatment current or in past 3 months [+2]

Status: Not yet recruiting

Adaptation of the STAIR-NT for First Responders

This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Florida State UniversityUpdated: Mar 5, 2026Locations: 1
Eligibility criteria

18 years or older [+3]

Does not meet inclusion criteria.

Status: Recruiting

Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes. The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging. In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.

Participants needed: 60
Trial details
Age: 36-71Biological sex: AllType: ObservationalSponsor: Institut National de la Santé Et de la Recherche Médicale, FranceUpdated: Mar 5, 2026Locations: 1
Eligibility criteria

Children aged between 36 months (3 years) and 71 months and 31 days (5 years; be... [+7]

Diagnosis of previous TBI (any severity, any age) [+8]

Status: Not yet recruiting

Efficacy and Safety of 6Degrees MyMove Interactive Virtual Reality Compared to Passive Virtual Reality in Subacute Stroke and Traumatic Brain Injury Rehabilitation: A Randomized Controlled Trial

Stroke and traumatic brain injury frequently result in persistent upper and lower limb motor impairment. While conventional rehabilitation improves outcomes, patient adherence and training intensity remain limiting factors. Immersive virtual reality (VR)-based therapy may enhance neuroplasticity by delivering high-intensity, task-oriented motor practice with enriched sensory feedback. This randomized controlled trial evaluates the efficacy and safety of the 6Degrees MyMove interactive VR system compared to passive VR exposure in individuals undergoing subacute inpatient rehabilitation after stroke or traumatic brain injury. Sixty participants will be randomized 1:1 to receive either interactive VR-based motor training or passive VR viewing, in addition to standard rehabilitation care, three times weekly for eight weeks. The primary objective is to determine whether interactive VR leads to greater improvement in motor function compared to passive VR. Secondary outcomes include dexterity, gait speed, functional independence, psychological status, adherence, usability, and safety.

Participants needed: 60
Trial details
Age: 40+Biological sex: AllType: InterventionalSponsor: Reuth Rehabilitation HospitalUpdated: Mar 2, 2026Locations: 1
Eligibility criteria

Time since neurological event: At least 2 weeks post-stroke or post-head injury. [+5]

Severe cognitive or language impairment: Cognitive deficits or language comprehe... [+3]

Status: Recruiting

Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

Preliminary evaluation of depth electrode recording and novel algorithms to determine Cortical Spreading Depolarization's (CSD) following traumatic brain injury (TBI) requiring neurosurgical intervention.

Participants needed: 15
Trial details
Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Feb 23, 2026Locations: 1
Eligibility criteria

Patient recommended to undergo EVD placement for the monitoring and possible tre...

Contaminated scalp lacerations [+3]

Status: Recruiting

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.

Participants needed: 42
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Texas Southwestern Medical CenterUpdated: Feb 18, 2026Locations: 1
Eligibility criteria

Post-resuscitation GCS score 12 or below and acute trauma-related intradural blo... [+2]

Hemodynamic instability [+6]

Status: Recruiting

Augmented Renal Clearance in Neurocritical Care

Stroke, severe brain injury, uncontrolled seizures and brain infections are the most common life-threatening neurological illnesses in the world with an estimated combined annual hospital management cost of up to 44 billion dollars. Seizures and infections are common complications following acute neurological illnesses and contribute significantly to poor outcomes if not promptly treated with appropriately dosed anti-seizure medications and antibiotics, respectively. Limited research suggested that many of those patients present with a phenomenon called augmented renal clearance (ARC) or, in other words, enhanced kidney function. ARC may have a significant influence on how medications are removed from the body potentially resulting in insufficient doses and treatment failure. Therefore, patients with ARC require higher medication doses; however, ARC is largely undetected using kidney assessment methods currently used in practice. In addition, it is not clear how medications should be dosed in those with ARC. The majority of ARC research has not focused on patients with life-threatening neurological illnesses. Thus, clinicians are likely under-dosing vital medications in those patients, and completely unaware. There is an immediate need to address the gap in knowledge. Therefore, this research aims to characterize the phenomenon of ARC in patients with life-threatening neurological illnesses through identifying the frequency, duration, contributing factors and clinical impact of ARC. Adult patients admitted to the neurosciences intensive care unit for life-threatening neurological illnesses will be enrolled in the study. Urine and blood samples wil be collected from participants to determine the presence of ARC and identify its contributing factors. In addition, blood samples will be collected from participants treated with select antibiotics and anti-seizure medications to determine their concentration and propose dose adjustment in those with ARC. This research is expected to improve the care of patients with life-threatening neurological illnesses through efficient identification and monitoring of patients exhibiting ARC facilitating timely medication dosage optimization. Furthermore, recommendations of optimal doses of commonly used medications in patients with ARC would improve the likelihood of treatment success with potential to improve patients' health and wellbeing.

Participants needed: 512
Trial details
Age: 18-85Biological sex: AllType: ObservationalSponsor: University of AlbertaUpdated: Feb 18, 2026Locations: 3
Eligibility criteria

Age 18-85 years [+4]

Incarceration [+1]

Status: Recruiting

Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test

The objective of this study is to identify determinants for implementing the i-STAT Alinity whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. The main questions it aims to answer are: 1. Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans. 2. What are the obstacles for using the i-STAT Alinity for its FDA-indicated use

Participants needed: 340
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shawn EagleUpdated: Feb 9, 2026Locations: 1
Eligibility criteria

Aged 18 or older [+4]

Treating emergency department provider does not think a head CT scan is needed [+11]

Status: Recruiting

Cognitive Remediation in Forensic Mental Health Care

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

Participants needed: 30
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: The Royal Ottawa Mental Health CentreUpdated: Dec 12, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy

The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans. 1. Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores? 2. To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.

Participants needed: 54
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Summit Hyperbarics and WellnessUpdated: Oct 9, 2025Locations: 1
Eligibility criteria

At least 18 years of age. [+8]

Untreated pneumothorax [+28]

Status: Not yet recruiting

Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro

The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant. The key questions that will be addressed in this study are: 1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively. 2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time. 3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency. 4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability. 5. Identify the extent to which personalization through a large language model (LLM) affects communication. 6. Identify the appropriate capabilities to enable through an agentic communication interface. Key measures include: ITR - information transfer rate SUS - system usability scale

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: CognixionUpdated: Oct 7, 2025Locations: 1
Eligibility criteria

Must have a designated on-site support individual who can be trained on the Cogn... [+5]

Disruption in English comprehension, either due to lack of fluent proficiency or... [+7]

Status: Recruiting

Evaluation of Decision-Making Fatigue After Traumatic Brain Injury

This is a preliminary, prospective, cohort study to investigate the feasibility of using the COGED and Restless Bandit tasks after a mild to moderate traumatic brain injury as well as in healthy controls.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Aug 5, 2025Locations: 1
Eligibility criteria

Adults 18 years and older [+8]

Status: Not yet recruiting

Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization

The goal of this clinical trial is to assess if EVD placement using augmented reality is non inferior to image-guidance systems for assistance in adult patients needing an EVD for spontaneous ICH with IVH or severe TBI. The main question it aims to answer is: Can EVDs be placed successfully with at least equal safety and efficacy using augmented reality devices in comparison to using standard image-guidance techniques?

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: The Cooper Health SystemUpdated: Jun 27, 2025Locations: 1
Eligibility criteria

adult patient at time of screening [+3]

Other concomitant intracranial pathology (e.g., tumor, tumor-related edema/hemor... [+2]