NCT04998916

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

With advances in optogenetic stimulation techniques, preclinical studies have demonstrated that activity in frontal-striatal neural circuits has a causal influence on heavy drinking and alcohol reinstatement. Clinically, however, this research has not yet been translated into a neural circuit based therapeutic technique for patients with alcohol use disorder (AUD). The long term goal of this multidisciplinary research study team is to determine the optimal parameters through which non-invasive transcranial magnetic stimulation can be used to improve alcohol drinking outcomes (abstinence, heavy drinking days) among individuals seeking behavioral treatment for AUD. Building on a foundation of several target identification studies and a small double-blinded clinical trial in treatment-engaged AUD patients performed by the study team in the Charleston Alcohol Research Center, here the investigator proposes a double-blind placebo controlled, randomized study to evaluate the efficacy of theta burst stimulation (TBS) to medial prefrontal cortex (mPFC) as a tool to decrease drinking and brain reactivity to alcohol cues among treatment-seeking individuals with AUD. Individuals will be screened initially by the Clinical Intake and Assessment core, then given an opportunity to enroll in this study, provide informed consent, and be randomized to receive real or sham TBS to the mPFC 36 sessions (3x/day on each of 3 days/week over 4 weeks, i.e., 12 days). The scientific premise of this 5 year proposal is that, by modulating the neural circuits that regulate alcohol cue-reactivity it will be possible to increase alcohol abstinence rates and decrease heavy drinking days over a 4 month period. With the combined scientific expertise in brain stimulation, neuroimaging, alcohol use disorder research in the Charleston Alcohol Research Center, and clinical practice at MUSC, the study team is uniquely suited to develop this critical line of research. The outcomes of the proposed Aims will provide an evidence-based foundation for a multisite clinical trial and will hasten progress towards developing a new neural circuit based treatment for patients with AUD.

Conditions

• Alcohol Use Disorder
• Alcohol Drinking
• Substance Use
• Drinking, Alcohol
• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DEVICE	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).
DEVICE	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.

Timeline

• Start date: 2021-07-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-08-10
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study