Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

NCT06415721 | Recruiting DMC FDA Device

• 1 other identifier: PADNEW_0003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.

Conditions

Alcohol Use Disorder; Alcohol Abuse; Alcoholism; Drinking Behavior; Drinking Problem

Keywords

Transcranial Magnetic Stimulation; Veterans; Neuroimaging; Relapse

Outcome Measures

Primary Outcomes (1)

• Change in blood-oxygen level dependent signal as a measure of change in alcohol cue reactivity

  The effect of real versus sham fMRI-guided TMS on alcohol cue reactivity will be assessed by comparing brain reactivity to images of alcohol ('alcohol cues') shown during the fMRI scan. Change in blood-oxygen level dependent signal magnitude will be measured within the striatum, a key brain region involved in cue-reactivity.

  Baseline (pre-TMS) and Day 2 (post-TMS)

Study Arms (2)

Active fMRI-guided TMS

EXPERIMENTAL

Device: Active Transcranial Magnetic Simulation

Sham fMRI-guided TMS

SHAM COMPARATOR

Device: Sham

Interventions

Active Transcranial Magnetic Simulation DEVICE

1 session of active continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. TMS will be delivered using the Magventure MagPro X100.

Also known as: MagVenture MagPro X100, Continuous Theta Burst Stimulation

Active fMRI-guided TMS

Sham DEVICE

1 session of sham continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. The MagVenture MagPro x100 is capable of administering a sham stimulation. The reverse side of the TMS coil is plated with a magnetic shield such that electromagnetic energy cannot stimulate the brain. The device offers compatibility with Transcutaneous Electrical Nerve Stimulation devices such that titrated electrical pulses can be delivered to the scalp location to mimic the sensation of a TMS pulse without stimulating the brain.

Also known as: MagVenture MagPro X100

Sham fMRI-guided TMS

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between age 25 and 75.
• Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
• Able to attend scheduled clinic visits
• Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
• If on a medication regimen, that regimen will be stable for the duration of the study;
• Fluency in English.

You may not qualify if:

• Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
• General medical condition, disease or neurological disorder that interferes with the assessments or participation.
• Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
• Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
• Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
• Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
• Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
• unstable chronic illness.
• Current or lifetime history of bipolar disorder or psychosis.
• Participation in another concurrent intervention based clinical trial.

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead
• Stanford University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Drinking Behavior; Recurrence

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel McCalley, PhD

  Palo Alto VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel McCalley

CONTACT

650-493-5000; mccalled@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: August 25, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Three to twelve months after publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)