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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Suspended
CT.gov ID
NCT04574167
Collaborator
Minneapolis Veterans Affairs Medical Center (U.S. Fed), University of Minnesota (Other)
120
1
2
48
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Active Transcranial Direct Current Stimulation (tDCS)
  • Device: Sham Transcranial Direct Current Stimulation (tDCS)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Treatment
Official Title:
Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: tDCS with Cognitive Training

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)

Device: Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Sham Comparator: Sham tDCS with Cognitive Training

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.

Device: Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).

Outcome Measures

Primary Outcome Measures

  1. Differences in change in frontal-striatal functional connectivity [Change between baseline and post-intervention (3 week) follow-up]

    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.

  2. Change in Trail Making Test (TMT) score [Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention]

    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.

  3. Change in Stroop Color-Word Test (SCWT) score [Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention]

    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.

  4. Change in binge drinking days per week as measured using the Timeline Followback questionnaire [Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota United States 55417

Sponsors and Collaborators

  • VA Office of Research and Development
  • Minneapolis Veterans Affairs Medical Center
  • University of Minnesota

Investigators

  • Principal Investigator: Kelvin O Lim, MD, Minneapolis VA Health Care System, Minneapolis, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04574167
Other Study ID Numbers:
  • MHBB-011-19S
  • VAM-19-00460
  • 1594744
First Posted:
Oct 5, 2020
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022