Frontopolar TMS to reduce alcohol craving
Investigation of Frontopolar Transcranial Magnetic Stimulation on Correlates of Craving in Alcohol Addiction
NA · Goethe University · NCT07064590
This study will try continuous theta burst transcranial magnetic stimulation (cTBS) over the left frontopolar cortex to see if it reduces cravings in adults with alcohol dependence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Goethe University (other) |
| Locations | 2 sites (Frankfurt am Main, Hesse and 1 other locations) |
| Trial ID | NCT07064590 on ClinicalTrials.gov |
What this trial studies
Adults with alcohol dependence will receive an accelerated cTBS protocol consisting of 15 TMS sessions delivered over five consecutive days. Participants will complete psychological craving scales (including the Penn Alcohol Craving Scale), physiological measures (heart rate, skin temperature, skin conductance) during virtual reality cue exposure, and MRI scans to measure baseline brain structural and functional connectivity. The study will compare craving-related psychological and physiological markers before and after the TMS intervention and explore whether baseline connectivity predicts individual response. A total of 34 patients aged 18–65 at Goethe University Hospital in Frankfurt will be enrolled.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with an ICD-10 diagnosis of alcohol dependence who can give informed consent, have sinus rhythm on ECG, and have no contraindications to TMS or MRI.
Not a fit: Patients with active psychosis, severe neurological disorders (such as epilepsy or recent stroke), contraindications to TMS or MRI, acute withdrawal symptoms, or recent seizures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a noninvasive treatment option that reduces alcohol craving and supports recovery efforts.
How similar studies have performed: Previous TMS and theta-burst studies for addiction and craving have shown promising but mixed results, so this builds on preliminary evidence rather than established proof.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adults aged 18-65 * ICD-10 diagnosis of alcohol dependence * Ability to give consent * Sinus rhythm in ECG Exclusion Criteria: * Current psychotic symptoms in patients with psychotic disorders (F20, F23, F10.5) * Contraindication against TMS or MRI * Severe neurological disorders such as epilepsy, stroke, neuroinflammatory disorders (e.g., multiple sclerosis). A history of seizures only in the context of alcohol withdrawal does not represent a contraindication, unless the seizure happened in the last 3 weeks before study inclusion. * Acute withdrawal symptoms (CIWA-Ar \> 5)
Where this trial is running
Frankfurt am Main, Hesse and 1 other locations
- Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt, Goethe-Universität — Frankfurt am Main, Hesse, Germany (RECRUITING)
- Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt, Goethe-Universität — Frankfurt am Main, Hesse, Germany (RECRUITING)
Study contacts
- Principal investigator: Jonathan Repple, Prof. Dr. — Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
- Study coordinator: Franka Timm, M.Sc.
- Email: f.timm@med.uni-frankfurt.de
- Phone: +49 171 9225424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Addiction, frontopolar transcranial magnetic stimulation, craving, alcohol addiction, addiction treatment, virtual reality, magnetic resonance imaging, Continuous Theta Burst Stimulation