Alcohol Use DisorderVR-WMRNCT03786276
Virtual Reality- Working Memory Retraining
A study testing VR-WMR-Only, Exercise-only and Active VR-WMR in people with Alcohol Use Disorder and Mild Traumatic Brain Injury, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Mild Traumatic Brain Injury
- What is being tested?
- VR-WMR-Only, Exercise-only and Active VR-WMR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center San Francisco
San Francisco, California, 94121
About this study
Official title: Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury
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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Mild Traumatic Brain Injury
- Being tested
- VR-WMR-Only, Exercise-only, Active VR-WMR
- Keywords
- Alcohol Use Disorder, Traumatic Brain Injury, Working Memory Training, Virtual Reality, Physical Exercise
- Medical subject headings
- Alcoholism, Brain Concussion, Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-WMR-OnlyBehavioural
Also called Virtual Reality-Working Memory Retraining
Participants will spend up to 30 minutes in a VR-WMR environment during each training session.
Exercise-onlyBehavioural
Also called Recumbent bicycle
Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.
Active VR-WMRBehavioural
Also called Active Virtual Reality-Working Memory Retraining
Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Active VR-WMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (1)
Working Memory
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will use an 8-week, randomized cross--over design trial of active VR-WMR.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco VA Health Care System
- Responsible party
- Sponsor
- Investigators
- David L Pennington, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786276
- Sponsor's protocol ID
- VR-WMR
- Acronym
- VR-WMR
- Status last verified
- Apr 2020
- First submitted
- 18 Dec 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35391785
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03786276
- Acronym / sponsor ID
- VR-WMR / VR-WMR
- Conditions
- Alcohol Use Disorder, Mild Traumatic Brain Injury
- Keywords
- Alcohol Use Disorder, Traumatic Brain Injury, Working Memory Training, Virtual Reality, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco VA Health Care System
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We will use an 8-week, randomized cross--over design trial of active VR-WMR.
| Arm | Type | Receives |
|---|---|---|
| Exercise-Only | Experimental | Behavioral: Exercise-onlyExercise-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. |
| VR-WMR-Only | Experimental | Behavioral: VR-WMR-OnlyVirtual 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. |
| Active VR-WMR | Experimental | Behavioral: Active VR-WMRAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-WMR-OnlyAlso: Virtual Reality-Working Memory RetrainingParticipants will spend up to 30 minutes in a VR-WMR environment during each training session. | Behavioural | VR-WMR-Only |
| Exercise-onlyAlso: Recumbent bicycleParticipants will ride a stationary recumbent bicycle for up to 30 minutes during each training session. | Behavioural | Exercise-Only |
| Active VR-WMRAlso: Active Virtual Reality-Working Memory RetrainingParticipants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session. | Behavioural | Active VR-WMR |
Primary outcome
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.
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.
1 secondary outcome
Working Memory
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Derived from this study: PubMed 35391785Pennington 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Pennington, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-WMR-Only, Exercise-only and Active VR-WMR in people with Alcohol Use Disorder and Mild Traumatic Brain Injury, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03786276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.