← Back to all trials
Recruiting
NCT07890337
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Conditions: Traumatic Brain Injuries, TBI (Traumatic Brain Injury), MTBI - Mild Traumatic Brain Injury, mTBI, Traumatic Brain Injury | Patient, Traumatic Brain Injury and Co-occurring Disorders, PTSD - Post Traumatic Stress Disorder
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Johns Hopkins University
Location: Johns Hopkins Bayview Medical Center - Pyschiatry Baltimore Maryland
Summary
The primary goal of this study is to evaluate the effectiveness of an integrated therapeutic model - combining VR and standard psychotherapy in improving executive function and hyperarousal adults impacted with mTBI. Specifically, the study will: Evaluate PTSD Symptom Reduction - PTSD symptoms, specifically hyperarousal and hypervigilance will be assessed using the Davidson Trauma Scale, which will provide insight into improvements PTSD symptom reduction.
Eligibility Criteria
Inclusion criteria:
* History of one or more concussions.
* Presence of mild-to-moderate PTSD symptoms, defined as a score between 20 and 44 on the Davidson Trauma Scale (DTS), indicating clinically relevant but not severe symptomatology (Davidson et al., 1997).
* Prior or ongoing therapy, defined as current or recent (within the last 3 months) engagement in standard care treatments such as psychiatric medication management, and evidence-based psychotherapy targeting mTBI or PTSD symptoms.
* Prior U.S military service (any duration and any branch) is required for eligibility.
Exclusion criteria:
* Age over 55 to reduce confounding effects of age-related neurodegeneration and cognitive decline.
* Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
* Active substance abuse.
* Presence of unrelated neurological conditions such as epilepsy, stroke, seizure disorders, or neurodegenerative diseases (e.g., Alzheimer's, Parkinson's).
* Significant cognitive impairment, assessed by standardized cognitive screening, which would interfere with the ability to participate fully in VR and therapy sessions.
* Physical impairments that would prevent safe engagement in VR and therapy.
Source: ClinicalTrials.gov (NCT07890337). StuddyBuddy aggregates publicly available trial information.