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
2 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 30, 2021
August 1, 2021
5.5 years
March 14, 2012
August 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
active rTMS
ACTIVE COMPARATORHigh frequency (10HZ) on the left DLPFC
sham rTMS
PLACEBO COMPARATORInterventions
Frequency (10hz) 120% motor threshold 10 sessions
Eligibility Criteria
You may qualify if:
- Diagnosis of alcohol dependence syndrome according to DSM-IV criteria
- Detoxified inpatients hospitalised for Alcohol Withdrawal for more than one week
- Giving written informed
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Mourier Hospital
Colombes, 92700, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline DUBERTRET
Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2012
First Posted
April 3, 2012
Study Start
February 11, 2011
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 30, 2021
Record last verified: 2021-08