Virtual Reality- Working Memory Retraining

Not Applicable

Completed

• Conditions: Mild Traumatic Brain Injury; Alcohol Use Disorder
• Interventions: Behavioral: Active VR-WMR; Behavioral: Exercise-only; Behavioral: VR-WMR-Only

• Registration Number: NCT03786276
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-26
• Study Start: 2019-02-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active VR-WMR	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.
Exercise-Only	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.
VR-WMR-Only	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.

Primary Outcome Measures

Name	Time	Method
The Client Satisfaction Questionnaire	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.
System Usability Scale	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.

Secondary Outcome Measures

Name	Time	Method
Working Memory	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.

Trial Locations

Locations (1)

VA Medical Center San Francisco; 🇺🇸 San Francisco, California, United States