Efficacity of rTMS in Alcohol Dependance

Alcohol Dependance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569399
• Other study ID #: C10-21
• Secondary ID: 2010-A00727-32
• Status: Completed
• Phase: N/A
• Start date: February 11, 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependance
• Alcoholism

Intervention

Other:
• rTMS (repetitive transcranial magnetic stimulation)
Frequency (10hz) 120% motor threshold 10 sessions

Locations

Country	Name	City	State
France	Louis Mourier Hospital	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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