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Tdcs And cogNitive traininG cOmbined for AUD (TANGO)

Primary Purpose

Alcohol Use Disorder, Addiction

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TaskFlow Transcranial Electrical Stimulation device

Executive Function Focused Cognitive Training

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

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

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

Sites / Locations

University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Participants receiving active transcranial direct current stimulation (tDCS)

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in Timeline Followback Questionnaire relapse rates

The Timeline Followback Questionnaire will be used to assess relapse status as a binary, (has or has not relapsed), at 1, 2, 3, and 4 months over the follow-up period. This is a measure of feasibility.

Difference in Timeline Followback Questionnaire abstinence period length

The Timeline Followback Questionnaire will be used to assess length of abstinence period measured in days at 1, 2, 3 and 4 months over the follow-up period. This is a measure of feasibility.

Change in D-KEFS Trail Making (1-5) score

The D-KEFS Trail Making (1-5) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Trail Making score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.

Change in D-KEFS Color Word score

The D-KEFS Color-Word Interference assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Color Word score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.

Change in Digit Span (WAIS IV) score

The Digit Span (WAIS IV) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Span (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.

Change in D-KEFS Verbal Frequency score

The D-KEFS Verbal Frequency assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Verbal Frequency score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.

Change in Digit Symbol (WAIS IV) score

The Digit Symbol (WAIS IV) assessment, also known as Coding, will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Symbol (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.

Change in functional connectivity

Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.

Change in task-evoked functional magnetic resonance signal

Number of transcranial direct current stimulation (tDCS) sessions completed

The number of tDCS sessions completed will be reported as a unitless average value as a measure of feasibility.

Secondary Outcome Measures

Full Information

NCT ID

NCT05062369

First Posted

September 21, 2021

Last Updated

March 31, 2023

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT05062369

Brief Title

Tdcs And cogNitive traininG cOmbined for AUD (TANGO)

Official Title

Tdcs And cogNitive traininG cOmbined for AUD (TANGO)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 3, 2022 (Actual)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Alcohol Use Disorder, Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Participants receiving active transcranial direct current stimulation (tDCS)

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

TaskFlow Transcranial Electrical Stimulation device

Other Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS), TaskFlow-TES

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Executive Function Focused Cognitive Training

Intervention Description

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 Information:

Title

Difference in Timeline Followback Questionnaire relapse rates

Description

Time Frame