Efficacity of rTMS in Alcohol Dependance

Not Applicable

Completed

• Conditions: Alcohol Dependance
• Interventions: Other: rTMS (repetitive transcranial magnetic stimulation)

• Registration Number: NCT01569399
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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

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).

Study Timeline

• Study Start: 2011-02-11
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham rTMS	rTMS (repetitive transcranial magnetic stimulation)	-
active rTMS	rTMS (repetitive transcranial magnetic stimulation)	High frequency (10HZ) on the left DLPFC

Primary Outcome Measures

Name	Time	Method
Superiority of left rTMS (DLPFC)on reduction of alcohol consumption in AD patients compared to sham rTMS	Patients will be followed during 6 month	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.

Trial Locations

Locations (1)

Louis Mourier Hospital; 🇫🇷 Colombes, France