Effects of Frontopolar TMS in Alcohol Craving

Summary

The goal of this interventional study is to learn if continuous theta burst stimulation (cTBS) applied over the left frontopolar cortex can reduce psychological, physiological, and neurobiological markers of alcohol craving in patients with alcohol dependence (AD).

The main questions it aims to answer are:

* Does cTBS over the left frontopolar cortex reduce psychological and physiological measures of alcohol craving in individuals with AD?
* Are baseline structural and functional brain connectivity patterns associated with individual differences in cTBS-induced changes in craving?

The participants will:

* Receive cTBS over the left frontopolar cortex using an accelerated protocol comprising 15 TMS-sessions on five consecutive days
* Undergo psychological and physiological assessments of alcohol craving before and after the TMS intervention
* Complete magnetic resonance imaging (MRI) sessions to assess baseline brain structural and functional connectivity

This study aims to advance the understanding of the neurophysiological mechanisms underlying craving in AD and the identification of potential biomarkers for predicting psychological and physiological craving reductions.

Conditions

• Alcohol Addiction

Interventions

DEVICE

Transcranial Magnetic Stimulation (TMS)

Patients will receive cTBS, a five-minute protocol with inhibitory effects over the left frontal pole, using an accelerated design comprising three sessions daily for five consecutive days (15 sessions total). Stimulation will be delivered using a Magventure TMS device routinely used in clinical practice at the Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Frankfurt. TMS is generally well tolerated, with mild headache or scalp discomfort as common side effects. Localization will be based on individual MRI data: after cortical parcellation with FreeSurfer 7.4.1, the left frontal pole centroid will be extracted. Coil placement will be neuronavigated using the Localite Neuronavigator. Stimulation will be applied at 110% resting motor threshold (rMT; 3-pulse bursts at 50 Hz, 5 Hz interburst; 1800 pulses/train; 60 s intertrain). Intensity may be gradually increased until 110% rMT is reached.

Sponsors & Collaborators

• Goethe University

  lead OTHER

Principal Investigators

• Jonathan Repple, Prof. Dr. · Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt

• Mathias Luderer, Dr. med. · Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt

• Maren Schmidt-Kassow, Prof. Dr. · Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-16

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Germany

Study Locations