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Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans (tDCS/AUD)

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans receiving services through the MVAHCS
  • Current diagnosis of Alcohol Use Disorder according to DSM-5
  • Abstinent from alcohol use for at least one week (i.e., not in acute withdrawal)
  • Men and women 18-65 years of age
  • Stable on any medications in the judgement of the PI at baseline
  • Capable and willing to provide voluntary informed consent

Exclusion Criteria:

  • Current (within one month of enrollment) stimulant dependence based on clinical history
  • Significant neurological disorder or insult that would impact risk (based on the principal investigator's judgement and research literature)
  • Cognitive impairment as indicated by a score lower than or equal to 20 on the Montreal Cognitive Assessment (MoCA) or determined by the PI's judgement
  • Current active psychosis and mania
  • Significant suicide risk as indicated by MINI Interview
  • Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
  • Contraindications for MRI (e.g., unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, significant breathing or movement disorder, claustrophobia)
  • Positive pregnancy report in women of childbearing age/potential

Sites / Locations

  • Minneapolis VA Health Care System, Minneapolis, MNRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS with Cognitive Training

Sham tDCS with Cognitive Training

Arm Description

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes)

Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Outcomes

Primary Outcome Measures

Differences in change in frontal-striatal functional connectivity
Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over a 12-minute scan in order to gather resting state functional connectivity (RSFC). Hierarchical linear models will examine differences in change in target engagement (frontal-striatal RSFC) between active and sham tDCS conditions.
Change in Trail Making Test (TMT) score
The TMT is a neuropsychological test of visual attention and task switching. The test consists of two parts in which the participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility and executive functioning.
Change in Stroop Color-Word Test (SCWT) score
The SCWT is a neuropsychological test of the ability to inhibit cognitive interference which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Change in binge drinking days per week as measured using the Timeline Followback questionnaire
The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. Binge drinking is defined as men consuming 5 or more drinks or women consuming 4 or more drinks in about 2 hours.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2020
Last Updated
September 6, 2023
Sponsor
VA Office of Research and Development
Collaborators
Minneapolis Veterans Affairs Medical Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04574167
Brief Title
Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
Acronym
tDCS/AUD
Official Title
Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Minneapolis Veterans Affairs Medical Center, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Unfortunately, about 2/3 of those entering treatment will relapse within one year. Cognitive impairments found in chronic alcohol use interfere with adaptive behavior needed for successful recovery. These cognitive impairments and their underlying neural substrates may provide promising new targets for interventions that can reduce relapse rates. Evidence suggests that cognitive training can improve cognition in individuals with AUD, strengthen neural networks mediating cognition, and improve treatment outcome. However, cognitive training is effort intensive, has small effect sizes, and may have limited durability. The primary objective of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to enhance cognition in alcohol use disorder and improve treatment outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a double-blind, randomized, placebo (sham) controlled study of Veterans with AUD who will receive cognitive training and be randomized to either active or sham tDCS.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Following enrollment in the study, participants will be randomized to either active or sham tDCS. Random permuted blocks will be used to ensure equal treatment numbers at certain equally-spaced points in the sequence of participant assignment.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS with Cognitive Training
Arm Type
Experimental
Arm Description
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes)
Arm Title
Sham tDCS with Cognitive Training
Arm Type
Sham Comparator
Arm Description
Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Primary Outcome Measure Information:
Title
Differences in change in frontal-striatal functional connectivity
Description
Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over a 12-minute scan in order to gather resting state functional connectivity (RSFC). Hierarchical linear models will examine differences in change in target engagement (frontal-striatal RSFC) between active and sham tDCS conditions.
Time Frame
Change between baseline and post-intervention (3 week) follow-up
Title
Change in Trail Making Test (TMT) score
Description
The TMT is a neuropsychological test of visual attention and task switching. The test consists of two parts in which the participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility and executive functioning.
Time Frame
Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
Title
Change in Stroop Color-Word Test (SCWT) score
Description
The SCWT is a neuropsychological test of the ability to inhibit cognitive interference which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Time Frame
Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
Title
Change in binge drinking days per week as measured using the Timeline Followback questionnaire
Description
The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. Binge drinking is defined as men consuming 5 or more drinks or women consuming 4 or more drinks in about 2 hours.
Time Frame
Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans receiving outpatient clinical care services for Alcohol Use Disorder through the MVAHCS within six months prior to enrollment Current diagnosis of Alcohol Use Disorder according to DSM-5 Abstinent from alcohol use for at least one week prior to the baseline study visit (i.e., not in acute withdrawal) Men and women 22-65 years of age In the medical opinion of the PI, has been on a stable dose of all prescription and non-prescription medications (except for PRN medication) for at least 30 days prior to the baseline visit (Visit 1) Capable and willing to provide voluntary informed consent Exclusion Criteria: Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Cognitive impairment as indicated by a score lower than or equal to 20 on the Montreal Cognitive Assessment (MoCA) or determined by the PI's judgment Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records Participant answers YES to Question 3 and NO to Question 6 (Moderate Risk) or participant answers YES to Question 4, 5, or 6 (High Risk) on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp) Contraindications for MRI (e.g., unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, significant breathing or movement disorder, claustrophobia) as assessed by completing the UMN CMRR Subject Safety Screening Form A positive pregnancy test result in a woman of childbearing age/potential as agreed upon by the PI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel Moua, BA
Phone
(612) 467-4140
Ext
314140
Email
angel.moua@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia L Fenske, BA
Phone
(612) 467-4744
Ext
314744
Email
alicia.fenske@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelvin O Lim, MD
Organizational Affiliation
Minneapolis VA Health Care System, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia L Fenske, BA
Phone
612-467-4744
Ext
314744
Email
alicia.fenske@va.gov
First Name & Middle Initial & Last Name & Degree
Angel Moua, BA
Phone
(612) 467-4140
Ext
314140
Email
angel.moua@va.gov
First Name & Middle Initial & Last Name & Degree
Kelvin O Lim, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified data may be shared upon request.

Learn more about this trial

Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans

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