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Efficacity of rTMS in Alcohol Dependance

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ClinicalTrials.gov Identifier: NCT01569399
Recruitment Status : Unknown
Verified February 2015 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : April 3, 2012
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependance Other: rTMS (repetitive transcranial magnetic stimulation) Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: active rTMS
High frequency (10HZ) on the left DLPFC
Other: rTMS (repetitive transcranial magnetic stimulation)
Frequency (10hz) 120% motor threshold 10 sessions

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




Primary Outcome Measures :
  1. 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 ]
    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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569399


Locations
France
Louis Mourier Hospital Recruiting
Colombes, France, 92700
Contact: Caroline Dubertret, MD, PhD    0147606415    caroline.dubertret@lmr.aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Caroline DUBERTRET Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01569399     History of Changes
Other Study ID Numbers: C10-21
2010-A00727-32 ( Registry Identifier: IDRCB )
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Alcohol dependance
rTMS
craving
alcohol consumption

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs