Traumatic Brain InjuryNCT02899468

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

A study testing BrightBrainer Virtual Reality (BBVR) Rehabilitation System in people with Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 67 years
Conditions the study is for: Traumatic Brain Injury
What is being tested?: BrightBrainer Virtual Reality (BBVR) Rehabilitation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Oct 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 67 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889

Other trials in United States

About this study

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.

Read the 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
Being tested: BrightBrainer Virtual Reality (BBVR) Rehabilitation System
Keywords: TBI, Virtual Reality
Medical subject headings: Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BrightBrainer Virtual Reality (BBVR) Rehabilitation SystemDevice
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.

Study groups in NCT02899468
Study group	Role	What they receive
Active Treatment Group	Experimental	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. Receives: Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System
Wait-List Control Group	Other	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. Receives: Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of integration of two side-by-side BrightBrainer Virtual Reality (BBVR) Rehabilitation Systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.
Measured: At the midpoint (3 weeks)
Feasibility of integration of two side-by-side BBVR systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.
Measured: At the endpoint (6 weeks)

Secondary outcomes (11)

Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)
Technology Acceptance Questionnaire. To determine technology acceptance by subjects we will use a subjective evaluation rating questionnaire. The rating will be done using a 7-point Likert scale.
Measured: At the midpoint (3 weeks) of the active treatment for every participant.
Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)
Technology Acceptance Questionnaire. To determine technology acceptance by subjects we will use a subjective evaluation rating questionnaire. The rating will be done using a 7-point Likert scale.
Measured: At the endpoint (6 weeks) of the active treatment for every participant.
Participant cognitive performance
Neurocognitive Assessment. The Automated Neuropsychological Assessment Metrics (ANAM) is a library of 22 computer-based assessments that are sensitive to cognitive change in attention, concentration, reaction time, memory, processing speed, and decision-making.
Performance will also be gauged by recording subjects' performance on the BBVR.
Measured: Change in performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant motor function (range of motion, strength, and coordination) - Fugl-Meyer Assessment
Subjects will complete the Fugl-Meyer Assessment that measures range of motion, strength and coordination. Strength will be measured using isometric or isotonic measures of shoulder abduction, shoulder flexion, and shoulder rotation.
Measured: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant motor function - Jebsen Hand Function Test
Subjects will be administered the Jebsen Hand Function Test (JHFT). The JHFT is a clinically validated hand function test developed by Jebsen, Taylor, Treischmann, Trotter, and Howard in 1969. It is a standardized evaluative measure of functional hand motor skills, and consists of 7 timed tasks - that measure a) fine motor skills, b) weighted functional tasks, and c) non-weighted functional tasks.
Measured: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant motor function - Box and Blocks Test
Subjects will also be administered the Box and Blocks Test (BBT). The BBT measures gross manual dexterity and will be conducted bilaterally for the purpose of this study. The assessment consists of a wooden box divided into two compartments by a partition and 150 blocks. Subjects will be asked to move, one by one, blocks from one compartment of a box to another. For the purpose of this study, subjects will be presented with two boxes and asked to perform the assessment bilaterally.
Measured: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant functional performance
Subject's performance on the BBVR system will be recorded to gauge participant improvement on the BBVR system.
Measured: Change in functional performance over the course of active treatment.
Participant symptoms
Post-Traumatic Stress Disorder (PTSD). The PTSD Checklist, Civilian Version (PCL-C) is a self-report questionnaire on the presence and severity of PTSD symptoms.
Measured: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
Participant symptoms
Neurobehavior Symptom Inventory. The Neurobehavioral Symptom Inventory (NSI) is routinely used as a standard assessment tool to gauge post-concussive symptoms of TBI.
Measured: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
Participant symptoms
Mood. Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) is a shortened version of the Inventory of Depressive Symptomatology, Self-report (IDS-SR) that covers just items that assess Diagnostics and Statistics Manual (DSM)-IV criterion diagnostic symptoms for depression.
Measured: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
Reliability of the BBVR technology when deployed in a clinical setting
Recording of BBVR Performance. A log of system reliability will be kept to determine mean time between failure and type of malfunction. To monitor computer usage, type of games played, and progress, each session will generate a paper-printed and a digital report.
Measured: Throughout the duration of the study - expected to last one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Oct 2017

First posted14 Sep 2016 (estimated)
Study startJan 2016
Primary completionOct 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02899468
Sponsor's protocol ID: 412759
Status last verified: Apr 2018
First submitted: 24 Aug 2016
Last updated: 27 Apr 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 24679074

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
ClinicalTrials.gov ID: NCT02899468
Acronym / sponsor ID: 412759
Conditions: Traumatic Brain Injury
Keywords: TBI, Virtual Reality
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
Collaborators: Bright Cloud International Corp, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences
Study start: Jan 2016
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 14 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active Treatment Group	Experimental	Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation SystemActive 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.
Wait-List Control Group	Other	Device: BrightBrainer Virtual Reality (BBVR) Rehabilitation SystemSubjects 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.

Who may qualify

Ages: 18 to 67 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BrightBrainer Virtual Reality (BBVR) Rehabilitation SystemDuring 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.	Device	Active Treatment Group, Wait-List Control Group

Primary outcome

Feasibility of integration of two side-by-side BrightBrainer Virtual Reality (BBVR) Rehabilitation Systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
Time frame: At the midpoint (3 weeks)
Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.
Feasibility of integration of two side-by-side BBVR systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center.
Time frame: At the endpoint (6 weeks)
Clinician Feedback Questionnaire: In order to determine technology feasibility and technology acceptance by the healthcare provider, we will use a subjective evaluation rating questionnaire. The rating will be similar to that used in the subjects' questionnaire, however, questions will differ.

11 secondary outcomes

Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)
Time frame: At the midpoint (3 weeks) of the active treatment for every participant.
Subject and clinician acceptance of the BBVR system (ease of use, ease of set up and monitoring, ease of data report production, ease of monitoring two subjects simultaneously)
Time frame: At the endpoint (6 weeks) of the active treatment for every participant.
Participant cognitive performance
Time frame: Change in performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant motor function (range of motion, strength, and coordination) - Fugl-Meyer Assessment
Time frame: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant motor function - Jebsen Hand Function Test
Time frame: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant motor function - Box and Blocks Test
Time frame: Change in functional performance from baseline to completion of the wait-list (for the wait-list control group only), and end point (6 weeks) of active treatment.
Participant functional performance
Time frame: Change in functional performance over the course of active treatment.
Participant symptoms
Time frame: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
Participant symptoms
Time frame: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
Participant symptoms
Time frame: Change in symptom reporting from baseline to of the wait-list (for the wait-list control group only), midpoint (3 weeks) of active therapy, and end point (6 weeks) of active treatment.
Reliability of the BBVR technology when deployed in a clinical setting
Time frame: Throughout the duration of the study - expected to last one year.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
Background: PubMed 24679074Burdea 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.
Individual participant dataSharing planned: No

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
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Chronic Subdural Hematoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul F Pasquina, MD principal investigator

Walter Reed National Military Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of integration of two side-by-side BrightBrainer Virtual Reality (BBVR) Rehabilitation Systems into the clinical rehabilitation practice at Walter Reed National Military Medical Center. (time frame: At the midpoint (3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.