Recruiting

MPFC TBS

Sponsor:

Medical University of South Carolina

Code:

NCT04998916

Conditions

Alcohol Use Disorder

Alcohol Drinking

Substance Use

Drinking, Alcohol

Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Real TBS to the mPFC

Sham TBS to the mPFC

Study Details

Brief summary:

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Conditions

Alcohol Use Disorder

Alcohol Drinking

Substance Use

Drinking, Alcohol

Alcohol Use Disorder (AUD)

Study ID

NCT04998916

Start date

Jul 6, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the demonstrated effect50 on TMS-fMRI responses in addiction)
  • Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V
  • Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling.
  • Able to read and understand questionnaires and informed consent.

Exclusion Criteria:

  • Has metal placed above the neck
  • Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)
  • Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal
  • Has a history of claustrophobia
  • Has a history of chronic migraines
  • Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage
  • Has an unstable medical illness requiring planned medical/surgical intervention (e.g. chemotherapy, surgical procedure)
  • Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric/sleeping medications except for stable (1 month) antidepressants/SSRI's. \[Note: this criterion is for scientific rather than safety or patient comfort reasons\].
  • Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months
  • Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. \[Note: The inclusion of participants with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large\]
  • Has current suicidal ideation or homicidal ideation
  • Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real TBS to the mPFC

For continuous theta burst stimulation (cTBS), participants will receive 3 sessions of stimulation per visit over the left medial prefrontal cortex (mPFC) (each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec, 600 pulses/session, 60 sec intertrain interval; 120% RMT, MagPro; 10-15 min inter session interval) using a figure 8 coil (Coil Cool-B65 A/P).

sham comparator: Sham TBS to the mPFC

The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either real or sham stimulation. This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double-blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham (scale 1-10).

Interventions

Real TBS to the mPFC

This will be delivered with the Magventure Magpro system; 600 pulses of continuous theta burst stimulation with the active sham coil (double blinded using the integrated active sham system).

Sham TBS to the mPFC

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the integrated active sham system). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions.

Primary outcome measure

  • Change in Percent Heavy Drinking Days (PHDD) from baseline [ Time Frame: Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) ]
  • Change in Percent Days Abstinent (PDA) from baseline [ Time Frame: Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3) ]
  • Change in alcohol cue task MRI activation 1-week post treatment from baseline [ Time Frame: Baseline (Week 1), Post-treatment (4-weeks from baseline) ]

Central Contacts and Locations

Central contacts

Lisa M McTeague

842-792-8274mcteague@musc.edu

Rhia Walton

842-792-8274waltonrh@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Rhia Walton

843-792-8274waltonrh@musc.edu

Principal Investigator:

Lisa McTeague, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • Transcranial Magnetic Stimulation
  • Medial Prefrontal Cortex
  • Brain Stimulation
  • Non-invasive
  • Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-02.