Clinical trial NCT03786276: Virtual Reality- Working Memory Retraining
Official title: Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Mild Traumatic Brain Injury
Keywords: Alcohol Use Disorder
Traumatic Brain Injury
Working Memory Training
Virtual Reality
Physical Exercise
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco VA Health Care System
First posted: 2018-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will use an 8-week, randomized cross--over design trial of active VR-WMR.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale
timeFrame: 18 months
measure: The Client Satisfaction Questionnaire
timeFrame: 18 months
Secondary outcomes:
measure: Working Memory
timeFrame: 18 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: VA Medical Center San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: David L Pennington, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pennington DL, Reavis JV, Cano MT, Walker E, Batki SL. The Impact of Exercise and Virtual Reality Executive Function Training on Cognition Among Heavy Drinking Veterans With Traumatic Brain Injury: A Pilot Feasibility Study. Front Behav Neurosci. 2022 Mar 22;16:802711. doi: 10.3389/fnbeh.2022.802711. eCollection 2022.