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OpenTrials
Completed

NCT Number: NCT03786276

Virtual Reality- Working Memory Retraining

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Chemically-Induced Disorders Craniocerebral Trauma Head Injuries, Closed Mental Disorders Mild Traumatic Brain Injury Motor Activity Nervous System Diseases Substance-Related Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center San Francisco

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR-WMR-Only

Behavioral

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

Other names: Virtual Reality-Working Memory Retraining

Exercise-only

Behavioral

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

Other names: Recumbent bicycle

Active VR-WMR

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco VA Health Care System

Registry information

Official study title

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

Acronym: VR-WMR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2018
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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