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| ID | Type | Description | Link |
|---|---|---|---|
| VAM-19-00460 | Other Identifier | Minneapolis Veterans Affairs Medical Center | |
| 1594744 | Other Identifier | IRBNet |
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| Name | Class |
|---|---|
| Minneapolis Veterans Affairs Medical Center | FED |
| University of Minnesota | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS with Cognitive Training | Experimental | 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) |
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| Sham tDCS with Cognitive Training | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial Direct Current Stimulation (tDCS) | Device | Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 between baseline and post-intervention (3 week) follow-up |
| 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 between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention |
| 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 between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention |
| 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. | Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelvin O Lim, MD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | United States |
Deidentified data may be shared upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2025 | Jan 14, 2026 |
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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.
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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.
| Sham Transcranial Direct Current Stimulation (tDCS) | Device | Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session). |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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