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:
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
This study's enrollment of 90 is below the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →Centre Hospitalier Henri Laborit is the lead sponsor of 27 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Feb 2025, 95 months.
Of 29 interventional studies with no phase under Alcoholic Intoxication, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 58. This study's 95 months is above that.
How these figures are worked out, and which studies are left out of them.
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