Virtual Reality- Working Memory Retraining (VR-WMR)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Mild Traumatic Brain Injury; Alcohol Use Disorder

Treatments: Behavioral: Active VR-WMR; Behavioral: VR-WMR-Only; Behavioral: Exercise-only

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03786276

VR-WMR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Exercise-Only

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise-only

VR-WMR-Only

Experimental group

Description:

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.

Treatment:

Behavioral: VR-WMR-Only

Active VR-WMR

Experimental group

Description:

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.

Treatment:

Behavioral: Active VR-WMR