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

NCT ID: NCT02899468

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-10-31

Brief Summary

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.

Detailed 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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Treatment Group

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.

Group Type: EXPERIMENTAL

BrightBrainer Virtual Reality (BBVR) Rehabilitation System

Intervention Type: DEVICE

During the active treatment stage (3 sessions per week x 6 weeks), each BBVR therapy session will consist of a series of custom games targeting one or several cognitive domains of executive function, attention, short-term memory, working memory and language comprehension. In addition, the BBVR device incorporates uni- and bi-manual activities by having the subject manipulate hand-held devices, which are programmed to measure in real time the subject's 3D hand movement and index flexion/extension. Therefore, in addition to completing the cognitive tasks, subjects must manipulate virtual hands through a hand-held interface to also enhance visual-motor perception, hand-eye coordination, and upper limb function. In addition, wrist weights can be added to increase upper limb strength training.

Wait-List Control Group

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.

Group Type: OTHER

BrightBrainer Virtual Reality (BBVR) Rehabilitation System

Intervention Type: DEVICE

During the active treatment stage (3 sessions per week x 6 weeks), each BBVR therapy session will consist of a series of custom games targeting one or several cognitive domains of executive function, attention, short-term memory, working memory and language comprehension. In addition, the BBVR device incorporates uni- and bi-manual activities by having the subject manipulate hand-held devices, which are programmed to measure in real time the subject's 3D hand movement and index flexion/extension. Therefore, in addition to completing the cognitive tasks, subjects must manipulate virtual hands through a hand-held interface to also enhance visual-motor perception, hand-eye coordination, and upper limb function. In addition, wrist weights can be added to increase upper limb strength training.

Interventions

BrightBrainer Virtual Reality (BBVR) Rehabilitation System

During the active treatment stage (3 sessions per week x 6 weeks), each BBVR therapy session will consist of a series of custom games targeting one or several cognitive domains of executive function, attention, short-term memory, working memory and language comprehension. In addition, the BBVR device incorporates uni- and bi-manual activities by having the subject manipulate hand-held devices, which are programmed to measure in real time the subject's 3D hand movement and index flexion/extension. Therefore, in addition to completing the cognitive tasks, subjects must manipulate virtual hands through a hand-held interface to also enhance visual-motor perception, hand-eye coordination, and upper limb function. In addition, wrist weights can be added to increase upper limb strength training.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bright Cloud International Corp

INDUSTRY

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul F Pasquina, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

References

Burdea G, Polistico K, Krishnamoorthy A, House G, Rethage D, Hundal J, Damiani F, Pollack S. Feasibility study of the BrightBrainer integrative cognitive rehabilitation system for elderly with dementia. Disabil Rehabil Assist Technol. 2015;10(5):421-32. doi: 10.3109/17483107.2014.900575. Epub 2014 Mar 29.

Reference Type: BACKGROUND

PMID: 24679074 (View on PubMed)

Other Identifiers

412759

Identifier Type: -

Identifier Source: org_study_id