RecruitingPhase 1interventionalRules rewrite

Phase 1: Virtual Reality for Traumatic Brain Injuries

The primary goal of this study is to measure 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.

Official registry: https://clinicaltrials.gov/study/NCT07890337 · Johns Hopkins University · enrollment listed as 30

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Virtual Reality, or Standard Psychotherapy. The registry lists allocation as randomized. The primary goal of this study is to measure the effectiveness of an integrated therapeutic model - combining VR and standard psychotherapy in improving executive function and hyperarousal adults impacted with mTBI.

They plan to enroll about 30 people at Baltimore. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)

Interventions: Virtual Reality, Standard Psychotherapy

Primary outcome (registry wording): Change in PTSD Symptom Severity Measured by the Davidson Trauma Scale (DTS)

Who it is for (from inclusion criteria)

Ages 18 Years to 55 Years
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 the registry excludes

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

Public study contact (from the registry)

Saumik Das

703-554-0332

sdas41@jh.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Johns Hopkins Bayview Medical Center - Pyschiatry — Baltimore, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07890337 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07890337?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07890337?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary