Virtual Reality- Working Memory Retraining

NCT03786276 | Completed

• 1 other identifier: VR-WMR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Mild Traumatic Brain Injury

Keywords

Alcohol Use Disorder; Traumatic Brain Injury; Working Memory Training; Virtual Reality; Physical Exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  18 months

Secondary Outcomes (1)

• Working Memory

  18 months

Study Arms (3)

Exercise-Only

EXPERIMENTAL

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.

Behavioral: Exercise-only

VR-WMR-Only

EXPERIMENTAL

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.

Behavioral: VR-WMR-Only

Active VR-WMR

EXPERIMENTAL

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.

Behavioral: Active VR-WMR

Interventions

VR-WMR-Only BEHAVIORAL

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

Also known as: Virtual Reality-Working Memory Retraining

VR-WMR-Only

Exercise-only BEHAVIORAL

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

Also known as: Recumbent bicycle

Exercise-Only

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.

Also known as: Active Virtual Reality-Working Memory Retraining

Active VR-WMR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco VA Health Care System: collaborator

Study Sites (1)

VA Medical Center San Francisco

San Francisco, California, 94121, United States

Location

Related Publications (1)

• 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.

  PMID: 35391785 DERIVED

MeSH Terms

Conditions

Alcoholism; Brain Concussion; Brain Injuries, Traumatic; Motor Activity

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Study Officials

• David L Pennington, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will use an 8-week, randomized cross--over design trial of active VR-WMR.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 26, 2018
• Study Start: February 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Locations

US (1)