Efficacity of rTMS in Alcohol Dependance

Study Overview
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Brief Summary
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Prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral prefrontal cortex (DLPFC). The aim of the investigators study was to investigate the effect of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham stimulation on craving and alcohol consumption.

Detailed Description
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Prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral prefrontal cortex (DLPFC). The aim of our study was to investigate the effect of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham stimulation on craving and alcohol consumption. 150 detoxified patients are randomized either to a high frequency rTMS over the left DLPFC (n = 75) or a sham stimulations (n = 75). Alcohol craving is determined with the Obsessive Compulsive Drinking Scale. Patients are allocated to active and sham rTMS in a 1: 1 ratio, such that 75 patients received active and 75 patients sham rTMS to the left DLPFC (10 Hz frequency, total 10 sessions). The Alcohol Craving Questionnaire (ACQ-NOW) and the Obsessive Compulsive Drinking Scale (OCDS) are administered to measure the severity of alcohol craving at baseline, after the last rTMS session and day 15, M1, M3, M6 after. Alcohol drinking is evaluated with Timeline Followback (TLFB).

Official Title
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Evaluation de l'efficacité thérapeutique de la Stimulation magnétique transcrânienne répétée Sur le Traitement du Craving à l'Alcool et la prévention de la Rechute Alcoolique à 6 Mois Chez Les Sujets dépendants et Des Facteurs génétiques déterminant la réponse thérapeutique

Conditions
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Alcohol Dependance

Intervention / Treatment
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* Other: rTMS (repetitive transcranial magnetic stimulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of alcohol dependence syndrome according to DSM-IV criteria Detoxified inpatients hospitalised for Alcohol Withdrawal for more than one week Giving written informed Exclusion Criteria: Left-handed patients at the time of inclusion. Age < 18 years Withdrawal Assessment (CIWA-Ar) scores of > 5 Patients with major medical or neurological disorders or with a pacemaker or metal in any part of the body were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active rTMS<br>High frequency (10HZ) on the left DLPFC | Other: rTMS (repetitive transcranial magnetic stimulation)<br>* Frequency (10hz) 120% motor threshold 10 sessions<br>|
| Placebo Comparator: sham rTMS<br> | Other: rTMS (repetitive transcranial magnetic stimulation)<br>* Frequency (10hz) 120% motor threshold 10 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of left rTMS (DLPFC)on reduction of alcohol consumption in AD patients compared to sham rTMS | Evaluation of the intensity of craving (AUQ, Borg analogic scale, OCDS) and total day with no alcohol use measured with TLFB at Day 0, Day 5, Day 15, Month1 , Month3 and Month6 in AD outpatients. | Patients will be followed during 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol dependance, rTMS, craving, alcohol consumption