Effects of Frontopolar TMS in Alcohol Craving

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• TMS-induced changes in psychological alcohol craving assessed with the Penn Alcohol Craving Scale (PACS) — The PACS will be assessed at baseline before the start of the TMS Intervention (Pre-TMS, Day 0) and after the final TMS session (post-TMS, Day 5)
  The primary outcome measure is the TMS-induced changes in psychological craving intensity. Self-reported psychological alcohol craving as measured by the Penn Alcohol Craving Scale (PACS) will be assessed before the frontopolar TMS intervention (pre-TMS at baseline) and after the final frontopolar TMS session (post-TMS). The PACS is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scored on a scale of 0 to 6. The mean total score across the five items (range 0-6) will be calculated, with higher scores indicating greater craving. In exploratory analyses, individual PACS items can also be examined separately to capture distinct dimensions of craving (e.g., frequency, intensity, or duration).

Trial sites (2)

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