Tdcs And cogNitive traininG cOmbined for AUD (TANGO)

• ClinicalTrials.gov Identifier: NCT05062369
• Recruitment Status: Recruiting
• First Posted: September 30, 2021
• Last Update Posted: April 7, 2022
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Use Disorder; Addiction	Device: TaskFlow Transcranial Electrical Stimulation device; Behavioral: Executive Function Focused Cognitive Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
• Actual Study Start Date: March 3, 2022
• Estimated Primary Completion Date: September 2025
• Estimated Study Completion Date: September 2025

Arms and Interventions

Arm	Intervention/treatment
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.	Device: 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.; Other Names: Transcranial Direct Current Stimulation (tDCS); TaskFlow-TES; Behavioral: 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).
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.	Device: 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.; Other Names: Transcranial Direct Current Stimulation (tDCS); TaskFlow-TES; Behavioral: 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).

Outcome Measures

Primary Outcome Measures :

1. Difference in Timeline Followback Questionnaire relapse rates [ Time Frame: Up to 4 months post-intervention ]
   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.
2. Difference in Timeline Followback Questionnaire abstinence period length [ Time Frame: Up to 4 months post-intervention ]
   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.
3. Change in D-KEFS Trail Making (1-5) score [ Time Frame: Up to 4 months post-intervention ]
   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.
4. Change in D-KEFS Color Word score [ Time Frame: Up to 4 months post-intervention ]
   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.
5. Change in Digit Span (WAIS IV) score [ Time Frame: Up to 4 months post-intervention ]
   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.
6. Change in D-KEFS Verbal Frequency score [ Time Frame: Up to 4 months post-intervention ]
   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.
7. Change in Digit Symbol (WAIS IV) score [ Time Frame: Up to 4 months post-intervention ]
   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.
8. Change in functional connectivity [ Time Frame: Day 3, Day 9, Day 17, and 1 month ]
   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.
9. Change in task-evoked functional magnetic resonance signal [ Time Frame: Day 3, Day 9, Day 17, and 1 month ]
   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.
10. Number of transcranial direct current stimulation (tDCS) sessions completed [ Time Frame: Days 4-16 ]
    The number of tDCS sessions completed will be reported as a unitless average value as a measure of feasibility.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jazmin Camchong, PhD; (612) 842-8704; camch002@umn.edu

Contact: Hannah Verdoorn; (612) 842-8704; verdo018@umn.edu

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55414

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Jazmin Camchong, PhD; Univeristy of Minnesota Department of Psychiatry & Behavioral Sciences

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05062369
• Other Study ID Numbers: STUDY00013676
• First Posted: September 30, 2021
• Last Update Posted: April 7, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• 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.: No

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders