Clinical trial NCT01569399: Efficacity of rTMS in Alcohol Dependance
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependance
Keywords: Alcohol dependance
rTMS
craving
alcohol consumption
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-04-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Superiority of left rTMS (DLPFC)on reduction of alcohol consumption in AD patients compared to sham rTMS
timeFrame: Patients will be followed during 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier Hospital
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Caroline DUBERTRET
role: PRINCIPAL_INVESTIGATOR
References: