NCT07890337 Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
| NCT ID | NCT07890337 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Traumatic Brain Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-11 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-11 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Saumik Das
STUDY DIRECTOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07890337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Traumatic Brain Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07890337 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07890337 currently recruiting?
Yes, NCT07890337 is actively recruiting participants. Contact the research team at sdas41@jh.edu for enrollment information.
Where is the NCT07890337 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07890337 clinical trial?
NCT07890337 is sponsored by Johns Hopkins University. The principal investigator is Saumik Das at Johns Hopkins University. The trial plans to enroll 30 participants.