Recruiting

Tdcs & Cognitive Training

Sponsor:

University of Minnesota

Code:

NCT05062369

Conditions

Alcohol Use Disorder

Addiction

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

TaskFlow Transcranial Electrical Stimulation device

Executive Function Focused Cognitive Training

Study Details

Brief summary:

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. The exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.

Conditions

Alcohol Use Disorder

Addiction

Study ID

NCT05062369

Start date

Mar 3, 2022

Status verified date

Oct, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD
  • Abstinent from alcohol use
  • Must have the intention to remain in the Lodging Plus program until the end of the intervention portion of the study.

Exclusion Criteria:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
  • A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
  • Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
  • Any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); Participants with other treated and stable psychiatric disorders will be included
  • Presence of a condition that would render study measures difficult or impossible to administer or interpret
  • Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
  • Clinical evidence for Wernicke-Korsakoff syndrome
  • Left-handedness
  • Entrance to the treatment program under a court mandate

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving active transcranial direct current stimulation (tDCS)

Participants in this group will receive 5 sessions of active transcranial direct current stimulation (tDCS) to dorsolateral prefrontal cortex (DLPFC) while in the Lodging Plus treatment program and then 5 remote sessions of active tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data.

sham comparator: Participants receiving active and sham active transcranial direct current stimulation (tDCS)

Participants in this group will receive 5 sessions of sham-tDCS sessions while in the Lodging Plus treatment program and then 5 remote sessions of active-tDCS to DLPFC after discharge from the treatment program. All participants will engage in executive functioning tasks for cognitive training during tDCS intervention (active or sham) to prime the engagement of the nucleus accumbens prefrontal cortex circuit. All participants will complete 4 MRI sessions. Craving measures will be collected before the first and after the last day of tDCS sessions. Follow-up interviews will be conducted monthly during a 4-month follow-up period after intervention completion to query relapse status. The first two follow-up interviews, at approximately 1- and 2-months post-intervention, will also include collection of cognition data.

Interventions

TaskFlow Transcranial Electrical Stimulation device

The TaskFlow Transcranial Electrical Stimulation device (TaskFlow-TES) is a custom brain stimulation device developed in-house at the University of Minnesota. Each tDCS intervention will last 20 minutes of either (i) 10 active (2-mA) or (ii) 5 active and 5 sham transcranial direct current stimulation (tDCS) over the course of 10 treatment sessions.

Executive Function Focused Cognitive Training

Working memory focused training occurs on a computer and consists of a variety of exercises selected to (i) place demands on the executive and storage functions of working memory (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across verbal, visual and spatial modalities. Training tasks are developed in-house. Tasks for each participant are delivered from and responses, audio, and video are stored on the HST server. The aim of using multiple tasks that require executive functions is to engage brain network functional connectivity in a number of different ways to promote generalization. Investigators will monitor each participant's training and customize the intervention to balance challenge and engagement. In addition, pre- and post-intervention, participants will perform 4-minute versions of a word and a spatial 3-back task identical across all weeks (but differing from the assessment versions).

Primary outcome measure

  • Difference in Timeline Followback Questionnaire relapse rates [ Time Frame: Up to 4 months post-intervention ]
  • Difference in Timeline Followback Questionnaire abstinence period length [ Time Frame: Up to 4 months post-intervention ]
  • Change in D-KEFS Trail Making (1-5) score [ Time Frame: Up to 4 months post-intervention ]
  • Change in D-KEFS Color Word score [ Time Frame: Up to 4 months post-intervention ]
  • Change in Digit Span (WAIS IV) score [ Time Frame: Up to 4 months post-intervention ]
  • Change in D-KEFS Verbal Frequency score [ Time Frame: Up to 4 months post-intervention ]
  • Change in Digit Symbol (WAIS IV) score [ Time Frame: Up to 4 months post-intervention ]
  • Change in functional connectivity [ Time Frame: Day 3, Day 9, Day 17, and 1 month ]
  • Change in task-evoked functional magnetic resonance signal [ Time Frame: Day 3, Day 9, Day 17, and 1 month ]
  • Number of transcranial direct current stimulation (tDCS) sessions completed [ Time Frame: Days 4-16 ]

Central Contacts and Locations

Central contacts

Jazmin Camchong, PhD

(612) 842-8704camch002@umn.edu

Clarista Berg

berg2920@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-10-09.