Virtual Reality- Working Memory Retraining

University of California, San Francisco30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Alcohol Use Disorder Mild Traumatic Brain Injury

Interventions

VR-WMR-OnlyBEHAVIORAL

Participants will spend up to 30 minutes in a VR-WMR environment during each training session.

Exercise-onlyBEHAVIORAL

Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.

Active VR-WMRBEHAVIORAL

Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Medical Center San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

System Usability Scale

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.

Time frame: 18 months

The Client Satisfaction Questionnaire

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.

Time frame: 18 months

Secondary Outcomes

Working Memory

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.

Time frame: 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.