Interest of tDCS in Help for Supporting Alcohol Abstinence

Alcoholic Intoxication Clinical Trial

— ITAMAA  

Official title:

Interest of tDCS in Help for Supporting Alcohol Abstinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03287154
• Other study ID #: 2016-A00304-47
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Nematollah Jaafari, Professor
• Phone: 0033 5 16 52 61 18
• Email: nemat.jaafari[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• Pre-inclusion visit

• V0 visit (inclusion visit): takes place at the earliest 48 hours after stopping benzodiazepines used in the withdrawal period.

• Treatment (weeks 0 and 1): 5 days of treatment per week during 2 weeks 2 arms : sham (placebo, 10 stimulations) vs active (10 stimulations of 2 mA)

• Visit 1 (Week 4) : short nurse consultation

• Visit 2 (Week 6) : short medical consultation

• Visit 3 (Week 10) : short medical consultation

• Visit 4 (Week 14) : long medical consultation

• Visit 5 (Week 18) : nurse phone follow-up

• Visit 6 (Week 22) : nurse phone follow-up

• Visit 7 (Week 26) : long medical consultation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patient aged from 18 to 70 years old

• patient free, without guardianship

• absence of epileptic pathology

• patient affiliated to the french health security or benefiting through a third party

• signed informed consent after having received a clear and honest information on the study.

• patient with a disorder linked to the use of alcohol (define by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification) clinically evaluated.

• patient requesting for an alcohol withdrawal

• patient able to read and write

Exclusion Criteria:

• patient not affiliated to the french health security or not benefiting through a third party

• woman in reproductive capacity without effective contraception (hormonal/mechanical:

per os, injectable, transcutaneous, implantable, intra-uterine device or chirurgical:

tubal ligation, hysterectomy, total ovariectomy) or breastfeeding

• patient hospitalized under duress

• patient with guardianship

• somatic complications during the alcohol withdrawal phase

• current psychiatric decompensation (mood disorder, suicide risk, psychotic disorders).

• patient under benzodiazepines treatment

• patient with scalp cutaneous lesion

• history of cranial traumatism

• patient with intra-cerebral metallic object

• patient with a pacemaker

• epileptic pathology

• patient in emergency condition or unable to give personally her/his consent

• another dependence other than alcohol or tobacco

• mental illness syndrome and Korsakoff

Related Conditions & MeSH terms

• Alcohol Abstinence
• Alcoholic Intoxication

Intervention

Device:
• Active tDCS stimulations
20 min, 2mA
• Sham tDCS
20 min, Sham

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers
France	Centre Hospitalier Nord-Deux-Sèvres	Thouars

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Relapse control	Evaluation of tDCS interest in help for relapse control.	6 months
Secondary	Alcohol consumption	Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).	6 months
Secondary	Anxiety-depression	Impact on the anxiety-depression symptomatology	6 months
Secondary	Tobacco consumption	Impact on tobacco consumption (decrease of cigarette consumption).	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months