Efficacity of rTMS in Alcohol Dependance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-11

Study Completion Date

2016-08-31

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.

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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).

Conditions

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Alcohol Dependance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active rTMS

High frequency (10HZ) on the left DLPFC

Group Type ACTIVE_COMPARATOR

rTMS (repetitive transcranial magnetic stimulation)

Intervention Type OTHER

Frequency (10hz) 120% motor threshold 10 sessions

sham rTMS

Group Type PLACEBO_COMPARATOR

rTMS (repetitive transcranial magnetic stimulation)

Intervention Type OTHER

Frequency (10hz) 120% motor threshold 10 sessions

Interventions

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rTMS (repetitive transcranial magnetic stimulation)

Frequency (10hz) 120% motor threshold 10 sessions

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No