An interventional study of Active tDCS stimulations and Sham tDCS in Alcoholic Intoxication, sponsored by Centre Hospitalier Henri Laborit. Completed at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Centre Hospitalier Henri Laborit · Not applicable, Interventional, and Treatment
The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of abstinence at 3 months.
The study takes place at one site (Henri Laborit Hospital, Poitiers, France) and is comparative, randomized and controlled.
There are 2 groups : one group is receiving sessions of active tDCS (active group) whereas the second group is receiving sham (placebo) sessions (control group).
Patients are randomized either in the active group or in the control group with a 1:1 ratio.
An unblinded investigator is responsible of the stimulation part and could not evaluate the patients. The other investigators are blinded and could evaluate the patients.
The study is going to evaluate the effect produces by stimulations in the two groups.
In the placebo group, after the intensity has reached its maximal intensity (the same as in the active group), the stimulation is stopped after few seconds (30 seconds in mostly studies). This process allow patients in the placebo group to feel the same sensations as patients in the active group (indeed, tingles and itches are felt only during the first few seconds of stimulation). The poor duration of stimulation do not produces clinical effect.
The study begins after a withdrawal period of 7 days +/- 3 days with 10 stimulations of 2 mA during 20 minutes from Monday to Friday during 2 weeks.
Following these stimulation sessions, the patient will have 5 follow-up visits on site with an investigator and 2 phone follow-up.
Visits:
Exclusion Criteria:
Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).
Device: Active tDCS stimulations
Patients in this arm will receive 10 sham stimulations (1 stimulation per day from Monday to Friday during 2 weeks). As soon as the power will have reached the maximal intensity as in the active arm, the stimulation will be stopped.
Device: Sham tDCS
20 min, 2mA
20 min, Sham
Alcohol Abstinence
The primary outcome is to evaluate the interest of the transcranial Direct Current Stimulation (tDCS) for helping the abstinence support in addictive alcoholic patients.
Time frame: 3 months
Relapse control
Evaluation of tDCS interest in help for relapse control.
Time frame: 6 months
Alcohol consumption
Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).
Time frame: 6 months
Anxiety-depression
Impact on the anxiety-depression symptomatology
Time frame: 6 months
Tobacco consumption
Impact on tobacco consumption (decrease of cigarette consumption).
Time frame: 6 months
Safety assessment with adverse and/or intercurrent events analysis.
The clinical tolerability will be objectified through the analysis of adverse and /or intercurrent events occuring all along the study. Theses events will be assessed at every study visit during patient examination.
Time frame: 6 months
Cognitive functions assessments with the Moca-test questionnaire.
The score to the Moca-test will permit to assessed the cognitive functions from baseline (week 0) to the week 14 and from baseline from the week 26.
Time frame: 6 months
Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time frame: 6 months
Executive functions assessments with the Go NoGo task.
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time frame: 6 months
Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time frame: 6 months
Executive functions assessments with the Stroop test.
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time frame: 6 months
Executive functions assessments with the IOWA Gambling Task (IGT).
This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Henri Laborit