Interest of tDCS in Help for Supporting Alcohol Abstinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Alcohol Abstinence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active tDCS stimulations
Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).
干预措施: Active tDCS stimulations (Device)
Sham tDCS
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.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Alcohol Abstinence
时间窗: 3 months
The primary outcome is to evaluate the interest of the transcranial Direct Current Stimulation (tDCS) for helping the abstinence support in addictive alcoholic patients.
次要结局
- Alcohol consumption(6 months)
- Tobacco consumption(6 months)
- Executive functions assessments with the Go NoGo task.(6 months)
- Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).(6 months)
- Executive functions assessments with the Stroop test.(6 months)
- Cognitive functions assessments with the Moca-test questionnaire.(6 months)
- Executive functions assessments with the Wisconsin Card Sorting Test (WCST).(6 months)
- Relapse control(6 months)
- Anxiety-depression(6 months)
- Safety assessment with adverse and/or intercurrent events analysis.(6 months)
- Executive functions assessments with the IOWA Gambling Task (IGT).(6 months)