Tdcs And cogNitive traininG cOmbined for AUD (TANGO)

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Minnesota — Minneapolis

Identifiers

NCT: NCT05062369 · STUDY00013676

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗