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Efficacity of rTMS in Alcohol Dependance

Primary Purpose

Alcohol Dependance

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS (repetitive transcranial magnetic stimulation)
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependance focused on measuring Alcohol dependance, rTMS, craving, alcohol consumption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Louis Mourier Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active rTMS

sham rTMS

Arm Description

High frequency (10HZ) on the left DLPFC

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2012
Last Updated
August 27, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01569399
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2011 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependance
Keywords
Alcohol dependance, rTMS, craving, alcohol consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rTMS
Arm Type
Active Comparator
Arm Description
High frequency (10HZ) on the left DLPFC
Arm Title
sham rTMS
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
rTMS (repetitive transcranial magnetic stimulation)
Intervention Description
Frequency (10hz) 120% motor threshold 10 sessions
Primary Outcome Measure Information:
Title
Superiority of left rTMS (DLPFC)on reduction of alcohol consumption in AD patients compared to sham rTMS
Description
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.
Time Frame
Patients will be followed during 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DUBERTRET
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Mourier Hospital
City
Colombes
ZIP/Postal Code
92700
Country
France

12. IPD Sharing Statement

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Efficacity of rTMS in Alcohol Dependance

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