Virtual Reality- Working Memory Retraining (VR-WMR)

April 30, 2020 updated by: University of California, San Francisco

Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury

This study will establish the acceptability and feasibility of enrolling and retaining heavy drinking Veterans with mild traumatic brain injury (mTBI) in an 8-week, randomized cross-over design trial of active VR working memory retraining (WMR). This study will also seek to establish the efficacy of active VR-WMR to increase performance in executive function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will employ a physically active VR working memory retraining (VR-WMR) regimen utilizing components of Blue Goji VR Active Gaming. The synthesis of physical activity and an enriched VR environment is expected to yield superior working memory training stemming from greater neurological activation. This enhanced working memory training task will result in greater motivation to engage and complete a training regimen, thus fostering greater improvements in executive function than traditional working memory training tasks; ultimately resulting in increased self-control over alcohol use and other high-risk behaviors.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • VA Medical Center San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • must report "heavy" drinking by NIH/NIAAA criteria (>7 drinks/week for women; >14 drinks/week for men) for at least one week in the last 90 days
  • must meet moderate to severe criteria for current (past year) alcohol use disorder (AUD) by DSM-5
  • must express a desire to reduce, stop, or maintain cessation of alcohol use
  • must report a history of TBI as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury)

Exclusion Criteria:

  • Unstable medical or psychiatric disorders judged to be unstable in the clinical judgment of the PI
  • Current or past history of intrinsic cerebral tumors, HIV infection, cerebrovascular accident, aneurysm, arteriovenous malformations, myocardial infarction, cerebrovascular or peripheral vascular disease, type-1 diabetes, any cardiac, hepatic or renal diseases/disorders, surgical implantation of neurostimulators or cardiac pacemakers, medically diagnosed chronic obstructive pulmonary disease, demyelinating and neurodegenerative diseases, history of seizure disorder, and/or any physical disability making it impossible to use exercise equipment
  • No female participant will be pregnant or attempting to conceive
  • Concurrent participation in an AUD, cognitive training, or exercise study
  • Must not require acute medical detoxification from alcohol (CIWA-AD > 11) within the past week prior to study entry
  • Subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise-Only
Exercise-Only condition, 12 exercise sessions on a stationary recumbent bicycle over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.
Behavioral: Exercise-only
Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.
Other Names:
  • Recumbent bicycle
Experimental: VR-WMR-Only
Virtual Reality Working Memory Retraining-Only condition, 12 working memory retraining sessions over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.
Behavioral: VR-WMR-Only
Participants will spend up to 30 minutes in a VR-WMR environment during each training session.
Other Names:
  • Virtual Reality-Working Memory Retraining
Experimental: Active VR-WMR
After 4 weeks in one of the first two arms, the participants will have a 1-week washout followed by the Active VR-WMR arm. Participants will complete 12 Active VR-WMR sessions on a stationary recumbent bicycle over 4 weeks.
Behavioral: Active VR-WMR
Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
Other Names:
  • Active Virtual Reality-Working Memory Retraining

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 18 months
A validated measure of technology usability will be administered at end of study to assess the usability of Active VR-WMR.The System Usability Scale (SUS) is a reliable 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree used to measure product usability. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. An SUS score above a 68 would be considered above average and anything below 68 is below average.
18 months
The Client Satisfaction Questionnaire
Time Frame: 18 months
A validated measure of client satisfaction with an intervention will be administered at the end of study to evaluate satisfaction with Active VR-WMR. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. A standard mean rating of ≥ 24 will be considered acceptable.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory
Time Frame: 18 months
Change in working memory in each arm will be evaluated. Working Memory consists of well validated WAIS-IV Arithmetic and Digit Span Subscales. Working memory will be the average of the scaled scores (ss) of each subscale, with a mean (M) = 10 and a standard deviation (SD) = 3. The subtest ss range from 1 to 19.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

San Francisco VA Health Care System

Investigators

  • Principal Investigator: David L Pennington, Ph.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR-WMR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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