Efficacity of rTMS in Alcohol Dependance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01569399
First received: March 14, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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 Intervention
Alcohol Dependance
Other: rTMS (repetitive transcranial magnetic stimulation)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 14, 2012
Last Updated: March 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014