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Virtual Reality- Working Memory Retraining (VR-WMR)

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ClinicalTrials.gov Identifier: NCT03786276
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
San Francisco VA Health Care System
Information provided by (Responsible Party):
David L. Pennington, PhD, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Mild Traumatic Brain Injury Behavioral: VR-WMR-Only Behavioral: Exercise-only Behavioral: Active VR-WMR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: We will use an 8-week, randomized cross--over design trial of active VR-WMR.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise-Only
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
Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.
Other Name: Recumbent bicycle

Experimental: VR-WMR-Only
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
Participants will spend up to 30 minutes in a VR-WMR environment during each training session.
Other Name: Virtual Reality-Working Memory Retraining

Experimental: Active VR-WMR
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
Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
Other Name: Active Virtual Reality-Working Memory Retraining




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786276


Contacts
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Contact: Holly D Pothier, M.S.W. 415-221-4810 ext 22484 holly.pothier@va.gov

Locations
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United States, California
VA Medical Center San Francisco Recruiting
San Francisco, California, United States, 94121
Contact: David L Pennington, PhD    415-221-4810 ext 24504    david.pennington2@va.gov   
Contact: Brooke Lasher, BA    4152214810 ext 24495    brooke.lasher@va.gov   
Principal Investigator: David L Pennington, PhD         
Sponsors and Collaborators
University of California, San Francisco
San Francisco VA Health Care System
Investigators
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Principal Investigator: David L Pennington, Ph.D. University of California, San Francisco

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Responsible Party: David L. Pennington, PhD, Assistant Professor, Department of Pschiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03786276     History of Changes
Other Study ID Numbers: VR-WMR
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David L. Pennington, PhD, University of California, San Francisco:
Alcohol Use Disorder
Traumatic Brain Injury
Working Memory Training
Virtual Reality
Physical Exercise
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Alcoholism
Alcohol Drinking
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating