The effect of high-frequency rTMS on alcohol craving – Results from a double-blinded randomized sham-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in alcohol craving
研究概览
简要总结
High-frequency rTMS will be applied over the right prefrontal cortex (rPFC). Alcohol craving measured using the Alcohol Craving Questionnaire (ACQ)****-SF-R, tolerability and feasibility of administering rTMS and Alcohol use patterns, including abstinence duration, and relapse episodes via Time Line Follow Back method- alcohol (TLFB- Alcohol) will be assessed across five timepoints: baseline, post-treatment, one-month, three-month and six-month follow-up, compared to sham rTMS.
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 and Outcome Assessor 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
- •Adults more than or equal to 18 years with ICD 11 diagnosis of Alcohol Dependence.
- •Patients not in active withdrawal that is, CIWA-Ar less than or equal to 10 at enrollment.
- •Right-handed and willing to stay for 10-day intervention.
- •Provided written informed consent.
排除标准
- •History of seizures, epilepsy, or neurological conditions.
- •Implanted metal devices or medications lowering seizure threshold.
- •Severe psychiatric comorbidity like schizophrenia, BPAD etc,.
- •Pregnancy, lactation, or concurrent substance dependence.
结局指标
主要结局
Reduction in alcohol craving
时间窗: alcohol craving, measured using the Alcohol Craving Questionnaire (ACQ)-SF-R, across five timepoints: baseline, post-treatment, one-month, three-month and six-month follow-up, compared to sham rTMS.
次要结局
- tolerability and feasibility of administering rTMS, alcohol use pattern post-intervention.(baseline, post-treatment, one-month, three-month and six-month follow-up)
研究者
Dr Vijeyta N
Government Stanley medical college and hospital