Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Key facts
- Who runs it
- Johns Hopkins University
- Where
- Baltimore, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 30 people, planned
- Started
- Nov 2026
- Expected to end
- May 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Virtual Reality
- Standard Psychotherapy
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Physical impairments that would prevent safe engagement in VR and therapy
- Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)
- 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
- Age over 55 to reduce confounding effects of age-related neurodegeneration and cognitive decline
- Active substance abuse
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Where in United States
- Johns Hopkins Bayview Medical Center - PyschiatryBaltimore, United StatesContact: Durga Roy, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ReVIVE Virtual Reality + Standard CareTreatment being tested
Participants randomized to this arm will receive six weekly sessions of virtual reality (VR)-based rehabilitation in addition to standard care, including routine psychotherapy and medication management. Each session includes approximately 10 minutes of VR acclimation followed by 30 minutes of immersive VR activities designed to support emotional regulation, cognitive functioning, and functional rehabilitation. Activities incorporate mindfulness, breathing and grounding techniques, and everyday environments and tasks, with scenarios progressing in complexity. Intervention tolerability will be monitored using the Simulator Sickness Questionnaire administered before and after VR sessions.
Treatment: Virtual Reality and Standard Psychotherapy
- Standard Care OnlyExisting treatment, for comparison
Participants randomized to this arm will continue receiving standard care, including routine psychotherapy and medication management, without the addition of virtual reality (VR)-based rehabilitation. Participants will still complete study assessments at the scheduled time points to evaluate changes PTSD-related symptoms over the study period.
Treatment: Standard Psychotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07890337, who can take part
- Record updated
- 12 November 2026