30 Participants NeededMy employer runs this trial

Virtual Reality + Psychotherapy for Concussion

(ReVIVE Trial)

SD
DR
Overseen ByDurga Roy, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining virtual reality (VR) with regular therapy can enhance thinking skills and reduce stress symptoms in individuals with a history of concussions. Participants will receive either standard care or standard care plus VR, which includes activities like mindfulness and breathing exercises. The trial targets those with mild-to-moderate PTSD symptoms who have served in the military and are currently, or have recently been, in therapy.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

What prior data suggests that this integrated therapeutic model is safe for adults with mTBI?

Research has shown that virtual reality (VR) aids recovery from brain injuries, with positive results in 10 out of 11 studies. VR might enhance certain mental skills after a brain injury. However, some participants have reported "cybersickness," similar to motion sickness, causing dizziness or nausea.

Regarding safety, these studies indicate that most people tolerate VR well, but monitoring for cybersickness is crucial. Participants can then stop or adjust VR activities if discomfort arises.

In the current trial, researchers are testing VR alongside standard psychotherapy. As this trial is in the early stages, the focus is on how well participants tolerate this combination. This involves closely monitoring for side effects and making necessary adjustments to ensure safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of virtual reality (VR) combined with psychotherapy for treating concussions because it offers a unique approach to rehabilitation. Unlike standard care, which typically involves routine psychotherapy and medication management, this treatment incorporates immersive VR activities that support emotional regulation and cognitive functioning. The VR sessions include interactive activities like mindfulness and grounding techniques, simulating everyday environments to enhance functional rehabilitation. This innovative method not only aims to make therapy more engaging but might also accelerate the recovery process by providing a more comprehensive sensory experience.

What evidence suggests that this trial's treatments could be effective for mTBI?

Research has shown that virtual reality (VR) can aid in treating traumatic brain injuries (TBI). In 10 out of 11 studies, participants using VR therapy showed improvement, particularly in movement and cognitive skills. These studies often focus on enhancing movement and brain function. In this trial, participants in the "ReVIVE Virtual Reality + Standard Care" arm will receive VR-based rehabilitation alongside standard care. VR adapts exercises based on real-time feedback to meet individual needs, suggesting it might help reduce PTSD symptoms, such as being easily startled, and improve cognitive skills in people with mild traumatic brain injury (mTBI).678910

Who Is on the Research Team?

DR

Durga Roy, MD

Principal Investigator

Johns Hopkins University

SD

Saumik Das

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who have had a mild traumatic brain injury (like a concussion) and may also have symptoms of PTSD. Participants should be able to take part in therapy sessions and assessments.

Inclusion Criteria

I am currently or recently receiving standard care for mTBI or PTSD symptoms.
Prior U.S military service of any duration and any branch
History of one or more concussions
See 1 more

Exclusion Criteria

I am older than 55 years.
I have a neurological condition like epilepsy, stroke, or Alzheimer's disease.
I have significant memory or thinking problems that affect my ability to join therapy sessions.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six weekly sessions of virtual reality (VR)-based rehabilitation in addition to standard care, including routine psychotherapy and medication management.

6 weeks
6 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD-related symptoms using the Davidson Trauma Scale.

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Standard Psychotherapy
  • Virtual Reality

Trial Overview

The study compares two treatments: one group receives virtual reality-based therapy combined with standard psychotherapy, while the other gets only standard psychotherapy. The goal is to see which approach better improves thinking skills and reduces PTSD symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ReVIVE Virtual Reality + Standard CareExperimental Treatment2 Interventions
Group II: Standard Care OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Citations

Virtual reality in concussion management: from lab to clinic

VR-based postural control assessments suggest that visual motion is destabilizing following SRC perhaps indicating persistent perceptual-motion disintegration

Immersive virtual reality in traumatic brain injury rehabilitation

10 of 11 studies demonstrated improvement with VR therapy. VR was most frequently used to address gait or cognitive deficits. VR was most frequently used to ...

The Future of Virtual Reality in Brain Injury Rehabilitation

VR systems that can analyze real-time data from brain injury survivors, adjust therapy exercises accordingly, and provide personalized feedback.

University of Colorado-Boulder researchers are using ...

VR headset technology may bring meaningful progress to preventing further brain injury in all contact sports and this trial is a welcome ...

Virtual reality and VR-like technologies for the assessment ...

Rehabilitation outcomes improved across conventional, VR-based, and hybrid therapy groups, without consistent superiority of VR.

Immersive virtual reality in traumatic brain injury rehabilitation

10 of 11 studies demonstrated improvement with VR therapy. VR was most frequently used to address gait or cognitive deficits. CONCLUSIONS: While the current ...

University of Colorado-Boulder researchers are using ...

VR headset technology may bring meaningful progress to preventing further brain injury in all contact sports and this trial is a welcome ...

The Future of Virtual Reality in Brain Injury Rehabilitation

Advancements in machine learning and artificial intelligence are paving the way for VR systems that can analyze real-time data from brain injury survivors, ...

CLINICAL APPLICATION OF VIRTUAL REALITY IN ...

The purpose of this systematic review was to examine the applications of virtual reality (VR) in the clinical management of adults with concussions. Page 11 ...