Recruiting

Cerebellar tDCS

Sponsor:

Johns Hopkins University

Code:

NCT05732207

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

cerebellar transcranial direct current stimulation

Study Details

Brief summary:

The goal of this observational and interventional study is to better understand the involvement of the cerebellum in the brain reward system in persons with alcohol use disorder (AUD). The main questions it aims to answer are:

1. What is the nature of cerebellar input to the ventral tegmental area (VTA) in the brain reward system, and how is it perturbed in AUD?
2. What is the relationship between measures of cerebellar integrity and magnitude of reward activation to alcohol-related cues in cerebellar, VTA and other brain reward structures?
3. What is the therapeutic potential of cerebellar transcranial direct current stimulation (tDCS) for modulating alcohol cue reactivity, associated alcohol craving, and cerebellar - VTA functional connectivity in the brain reward system? Persons with AUD will be compared with healthy control participants.

Conditions

Alcohol Use Disorder

Study ID

NCT05732207

Start date

Oct 12, 2023

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • completed at least 8 years of education

Exclusion Criteria:

  • Estimated Intelligence Quotient (IQ) < 90
  • less than 5th grade reading level
  • Left handed
  • Non-fluent in English
  • current drug use disorder other than alcohol (except nicotine and caffeine) and or recent drug use in the last 90 days
  • Positive breath alcohol level at time of MRI scan or discrepancies between alcohol biomarker and self-report that cannot be resolved
  • Exhibiting symptoms of alcohol withdrawal on visit 1 assessment
  • Significant current psychiatric distress and or treatment
  • History of any central nervous system disorder, presence of a seizure disorder, or use of anticonvulsant medication in the past 3 months
  • any serious medical condition detected on assessment or by medical record review; or have liver function tests more than three times normal at screening
  • History of metal implantation that would preclude MRI scanning; or other implants, pumps, pacemakers that would be contraindications for MRI scanning
  • Abnormal MRI scan or history of significant closed head trauma
  • Evidence of dementia
  • For women, pregnancy

Study Design

Enrollment

122 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cathodal cerebellar transcranial direct current stimulation (ctDCS)

For ctDCS, the cathodal (-) electrode will be positioned over the right cerebellum 1 cm below and 3 cm lateral to the inion, and the anodal (+) electrode will be placed on the contralateral supraorbital area (FP2 EEG location).

experimental: Anodal cerebellar transcranial direct current stimulation (atDCS)

For atDCS, anode/cathode locations are reversed from those of ctDCS..

sham comparator: Sham cerebellar transcranial direct current stimulation (stDCS)

For stDCS, the electrodes will be configured randomly as atDCS 50% of the time, and as ctDCS 50% of the time.

Interventions

cerebellar transcranial direct current stimulation

TDCS is a safe and non-invasive technique for modulating cortical excitability and behavior. TDCS, delivered via surface electrodes, induces an intracerebral current flow sufficient to achieve changes in cortical excitability. Anodal stimulation up-regulates cortical excitability, while cathodal stimulation decreases excitability.

Primary outcome measure

  • Craving for alcohol during the cue reactivity task as assessed by a rating scale [ Time Frame: 28 minutes ]
  • Resting state functional connectivity during tDCS [ Time Frame: 28 minutes ]
  • Brain activation to alcohol cues [ Time Frame: 28 minutes ]
  • Brain functional connectivity to alcohol vs non-alcohol cues [ Time Frame: 28 minutes ]
  • Brain activation related to reward prediction during the monetary incentive task [ Time Frame: 18 minutes ]
  • Brain functional connectivity related to reward prediction during the monetary incentive task [ Time Frame: 18 minutes ]
  • Brain activation to reward prediction error during the monetary incentive task [ Time Frame: 18 minutes ]
  • brain functional connectivity to reward prediction error during the monetary incentive task [ Time Frame: 18 minutes ]
  • Percentage of trials with a conditioned response during the classical eyeblink conditional task [ Time Frame: 21 minutes ]
  • Mean time (in milliseconds) at which peak of conditioned response occurs during the classical eyeblink conditional task [ Time Frame: 21 minutes ]

Central Contacts and Locations

Central contacts

John E Desmond, PhD

410-502-3583jdesmon2@jhmi.edu

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • AUD
  • heavy drinking
  • hazardous drinking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-11.