Effects of adjuvant Transcranial Direct Current Stimulation (tDCS) on craving and relapse in Patients of Alcohol Dependence Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess reduction in craving and relapse in patients of Alcohol Dependence Syndrome after application of adjunct tDCS. The assessment will be done at baseline before starting treatment and then after 01 month and 03 months of application of adjunct tDCS. Change in craving will be assessed using Penn Alcohol Craving Scale. Value of 20 or more on the scale will be taken as threshold for craving.
研究概览
简要总结
An interventional study will be done in patients of Alcohol Dependence Syndrome who are hospitalised to a tertiary care hospital. All patients meeting ICD-10 criteria of Alcohol Dependence Syndrome admitted to our centre will be taken consent for study. All patients who give consent for study will be screened for inclusion and exclusion criteria. Patients remaining after application of inclusion and exclusion criteria will be assigned a random number centrally, not involving the researcher and study participants. A base line assessment of severity of drinking and craving for alcohol will be done by application of scales. Patients who will be assigned random number 5 and its successive numbers obtained after addition of 10 will be administered 10 cycles of tDCS over 5 days with 02 cycles per day of 20 minutes of each cycle. Patients who will be assigned random number 1, 10 and its successive additions of 10 will be given adjunct sham tDCS for equal number of cycles as true tDCS. Change in craving and relapse rates will be assessed again after 01 month and 03 months of initiation of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 58.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subjects fulfilling criteria of Alcohol Dependence syndrome as per ICD-10 and willing to give written concent for participation in the study.
排除标准
- •Any axis-1 psychiatric disorder, any other substance use disorder except nicotine, Any implanted metal device, head trauma, seizure, stroke, neurological disease, scalp injury/skip lesion.
结局指标
主要结局
To assess reduction in craving and relapse in patients of Alcohol Dependence Syndrome after application of adjunct tDCS. The assessment will be done at baseline before starting treatment and then after 01 month and 03 months of application of adjunct tDCS. Change in craving will be assessed using Penn Alcohol Craving Scale. Value of 20 or more on the scale will be taken as threshold for craving.
时间窗: To assess reduction in craving and relapse in patients of Alcohol Dependence Syndrome after application of adjunct tDCS. The assessment will be done at baseline before starting treatment and then after 01 month and 03 months of application of adjunct tDCS
次要结局
未报告次要终点
研究者
Shalini Bajpai
Base Hospital Delhi Cantt