Brain Injury Traumatic Mild

8

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

Condition / disease
Location
Status: Recruiting

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

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).

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jul 13, 2026Locations: 5
Eligibility criteria

Current or former member of the uniform services [+7]

History of neurological diseases other than TBI and not attributable to TBI [+2]

Status: Recruiting

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

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).

Participants needed: 360
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: May 28, 2026Locations: 5
Eligibility criteria

Current or former member of the uniform services [+7]

History of neurological diseases other than TBI and not attributable to TBI [+2]

Status: Not yet recruiting

Using Routine Inflammatory and Metabolic Blood Tests (Bedside Included) to Predict Brain Injury in Children After Minor Head Trauma

Traumatic brain injury (TBI) poses significant strains on the paediatric population, for which the possible side effects of diagnostic imagistics could induce life-altering conditions. Routine inflammatory and metabolic biomarkers (complete blood count, C reactive protein, glucose) are frequently sampled in the paediatric patients admited within emergency departments, including the low-resource settings. This study aims to retrospectively document whether such routine blood biomarkers could predict a positive head CT scan and subsequently contribute to a prediction score, ment to enable more accurate decision on which minor TBI paediatric patients should be submitted to diagnotic imagistics.

Participants needed: 800
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Iuliu Hatieganu University of Medicine and PharmacyUpdated: Mar 31, 2026Locations: 7
Eligibility criteria

Mild TBI will be defined as GCS 14-15 or A (AVPU) upon admission [+2]

Patients with moderate (GCS 13-9 or V) or severe (GCS 8-3 or P,U) head trauma [+1]

Status: Recruiting

Screening Emotions in Adolescents at the Hospital for mTBI

The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions. The main aims the study wish to answer are: * Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury? * Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires? Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.

Participants needed: 2,592
Trial details
Age: 11-17Biological sex: AllType: ObservationalSponsor: University of California, DavisUpdated: Sep 26, 2025Locations: 6
Eligibility criteria

Presentation to the ED >72 hours post-injury [+5]

Status: Recruiting

Spotting and Managing Adult Repeated Traumas in the Brain

Emerging evidence suggests that concussions (a type of mild traumatic brain injury; mTBIs) may cause chronic neurological disturbances with effects lasting beyond 20 years, changing brain structure and nearly doubling the risks of developing dementia into old age. Yet diagnoses remain notoriously difficult, gender differences are poorly understood, and negligible therapies exist to manage and treat these long-term effects. This project proposes using a combination of NeuroTracker (a promising software-based cognitive assessment and intervention for mild TBIs), with the latest MRI techniques and blood-based biomarkers of brain function, to provide unprecedented assessment sensitivity of long-term concussion effects, comparing older male and female adults, with and without a history of concussion. Additionally, NeuroTracker will be used as a therapeutic intervention to improve outcomes in adults with histories of concussion, with the combined assessments measuring efficacy pre-post training. This project aims to comprehensively understand the impacts of mild brain traumas into later life, via both physical and functional biomarkers of brain health. It will also validate the value of NeuroTracker as an accessible training intervention for recovering cognitive functions impacted by earlier-life concussions.

Participants needed: 200
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Université de MontréalUpdated: Jul 20, 2025Locations: 3
Eligibility criteria

It will be based on age (60+ years) and history of concussion (with the most rec...

Include the presence of a diagnosed neurological disorder (e.g. Mild Cognitive I...

Status: Recruiting

Concussion Health Improvement Program

More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.

Participants needed: 304
Trial details
Age: 11-18Biological sex: AllType: InterventionalSponsor: Seattle Children's HospitalUpdated: Mar 13, 2025Locations: 1
Eligibility criteria

11-18 years old [+2]

Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization... [+3]

Status: Recruiting

Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms. This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.

Participants needed: 120
Trial details
Age: 16+Biological sex: AllType: InterventionalSponsor: Universite de MonctonUpdated: Dec 13, 2024Locations: 1
Eligibility criteria

16 years or older [+2]

<16 years old [+4]

Status: Recruiting

Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health.

Participants needed: 80
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: East Bay Institute for Research and EducationUpdated: Nov 29, 2023Locations: 1
Eligibility criteria

18-75 years old [+3]

no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson... [+6]