Efficacy of High Definition-Transcranial Direct Current Stimulation (HD-tDCS) in Patients with Alcohol Dependence Syndrome (ADS) in Reducing Alcohol Cravings
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Demonstration of the effectiveness of HD-tDCS in reducing alcohol cravings
研究概览
简要总结
**This study is a randomised, single-blind, parallel-group, single-center trial of High Definition-Transcranial Direct Current Stimulation (HD-tDCS) in 50 Patients with Alcohol Dependence Syndrome (ADS) in Reducing Alcohol Cravings****for 6 months (approax.)**to demonstrate the effectiveness of HD-tDCS in reducing alcohol cravings and identification of tolerability, cognitive, and emotional changes associated with HD-tDCS treatment
Procedure
· HD-tDCS Protocol: Participants will receive 20-minute sessions of HD-tDCS at 2 mA intensity, 5 days per week, for 2 weeks. The anode will be placed over the left DLPFC (F3 position; beam F3), and 4 cathodes surrounding the area of stimulation.
· Sham Stimulation: The sham group will receive 20-minute sessions of HD-tDCS at 0.2 mA intensity, 5 days per week, for 2 weeks. The anode will be placed over the left DLPFC (F3 position; beam F3), and 4 cathodes surrounding the area of stimulation.
SCALES
-
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-AR)
-
Penn Alcohol Craving Scale (PACS)
-
Barratt Impulsivity Scale-11 (BIS-11)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •(1) Met criteria for alcohol dependence according to the International Classification of Disorders.
- •(ICD-10-CM Diagnosis Code F10.2) (2) Prior to participation, participants will give written, informed consent.
排除标准
- •(1) A condition of intoxication or withdrawal due to a substance other than alcohol.
- •(2) Diagnosis of epilepsy, convulsions, or delirium tremens during the abstinence of alcohol.
- •(3) A previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol.
- •(4) Any contraindication for electrical brain stimulation procedures such as electronic or metal implants.
结局指标
主要结局
Demonstration of the effectiveness of HD-tDCS in reducing alcohol cravings
时间窗: 3-point assessment will be done i.e., baseline, at the end of 2nd week & at the end of 4th week, during the trial.
次要结局
- Identification of tolerability, cognitive & emotional changes associated with HD-tDCS treatment.(3-point assessment will be done i.e., baseline, at the end of 2nd week & at the end of 4th week, during the trial.)
研究者
Aditya Rajan Shukla
Shri Guru Ram Rai University