- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569399
Efficacity of rTMS in Alcohol Dependance
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Colombes, France, 92700
- Louis Mourier Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: active rTMS
High frequency (10HZ) on the left DLPFC
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Frequency (10hz) 120% motor threshold 10 sessions
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Placebo Comparator: sham rTMS
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Frequency (10hz) 120% motor threshold 10 sessions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superiority of left rTMS (DLPFC)on reduction of alcohol consumption in AD patients compared to sham rTMS
Time Frame: Patients will be followed during 6 month
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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.
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Patients will be followed during 6 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Caroline DUBERTRET, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C10-21
- 2010-A00727-32 (Registry Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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