Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT02899468

412759

Details and patient eligibility

About

The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with traumatic brain injury (TBI). These patients, service members with TBI, can be both with and without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to improve cognitive and motor function, as well as mood.

Full description

Bright Cloud International Corp created BrightBrainer, a computerized virtual reality system that provides a combination of cognitive as well as motor skill training in an engaging and repetitive manner [1]. This project objective is to assess the feasibility and clinical benefit of utilizing the BBVR to augment the rehabilitation of service members with TBI. The BrightBrainerTM Virtual Reality (BBVR) Rehabilitation System is unique because it is designed to provide integrative, customized, intensive and self-guided therapy that simultaneously addresses the cognitive, emotive and motor deficits. Early evidence suggests that it has been effective for patients with cognitive deficits as the result of cerebrovascular accident or dementia, but has not yet been evaluated in a therapeutic intervention for patients with TBI. In addition to assessing the system's effect on patient's symptoms, we will also evaluate the feasibility of utilizing this system in a military environment by obtaining feedback from the patients and therapists, regarding system acceptance, reliability and ease of use.

Enrollment: 26 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female military health care beneficiaries 18-67 years of age;
• Presence of TBI (based on standard Veterans Affairs (VA)/ Department of Defense (DoD) criteria);
• With or without upper extremity dysfunction. Upper extremity dysfunction includes but is not limited to decreased coordination, increased tone, decreased strength, and decreased sensation;
• Ability to follow study instructions and likely to complete all required visits for the study;
• Ability to understand spoken and written English;
• At least 6 weeks post TBI.

Exclusion criteria

• Age less than 18 or greater than 67;
• Blind or otherwise visually impaired to the extent that lack of sight inhibits utilizing the system;
• Deafness;
• Inability to understand or comprehend consenting to the study;
• Active psychosis, suicidal or homicidal ideations or frequent violent episodes;
• Currently enrolled in active substance abuse treatment
• Inability to even minimally operate BBVR controllers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Active Treatment Group

Experimental group

Description:

Active treatment will consist of the BrightBrainer Virtual Reality (BBVR) Rehabilitation System therapy intervention (3 sessions per week x 6 weeks). Standard validated outcome measures which assess various domains of function, will be obtained at baseline and then at 3 and 6 weeks for those randomized to the Active Treatment group.

Treatment:

Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System

Wait-List Control Group

Other group

Description:

Subjects randomized to the Wait-List Control (WLC) group will wait 3 weeks before beginning the Active Treatment program intervention (3 sessions per week x 6 weeks) using the BrightBrainer Virtual Reality (BBVR) Rehabilitation System. For those randomized to the WLC group, outcome measures will be assessed at baseline, completion of waiting period (3 weeks), then at 3 and 6 weeks after initiating active treatment.

Treatment:

Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System