Evaluating the Impact of Adjuvant Repetitive Transcranial Magnetic Stimulation (rTMS) with Usual Care vs Sham rTMS with Usual Care on Alcohol Craving in Patients with Alcohol Dependence Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary endpoint is the change in alcohol craving scores from baseline to post-intervention (Day 11), and at 1-month and 3-month follow-ups, measured by Alcohol Craving Questionnaire NOW scale
研究概览
简要总结
Evaluating the Impact of Adjuvant Repetitive Transcranial Magnetic Stimulation with Usual Care vs Sham rTMS with Usual Care on Alcohol Craving in Patients with Alcohol Dependence Syndrome A Randomized Controlled Trial is a clinical study designed to examine the efficacy of rTMS as an adjunctive treatment in reducing alcohol craving among adults aged 18 to 60 years diagnosed with Alcohol Dependence Syndrome. Conducted at a tertiary care hospital in Western Maharashtra, the trial randomizes 150 participants into two groups active rTMS and sham stimulation with each receiving ten daily sessions 10 Hz, 1000 pulses per session over the left dorsolateral prefrontal cortex. Participants are assessed using the Alcohol Craving Questionnaire NOW at baseline, on day 11, and at 1 and 3 month followups. The intervention is grounded in neurobiological evidence that dysregulated prefrontal-limbic circuits drive craving and relapse. Studies by Harel et al and a 2025 meta-analysis by Treiber et al demonstrate that more than 10 sessions of high-frequency rTMS significantly reduce craving, with effects persisting up to three months. This project aims to generate robust Indian data on the effectiveness and sustainability of rTMS in relapse prevention, potentially integrating this non-pharmacological neuromodulation technique into standard care for alcohol dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 60.00 Day(s)(—)
- 性别
- All
入选标准
- •Adults aged 18-60 years diagnosed with Alcohol Dependence Syndrome.
排除标准
- •History of epilepsy or seizure disorders Presence of metal implants or devices Severe psychiatric conditions Severe debilitating medical / surgical conditions.
结局指标
主要结局
The primary endpoint is the change in alcohol craving scores from baseline to post-intervention (Day 11), and at 1-month and 3-month follow-ups, measured by Alcohol Craving Questionnaire NOW scale
时间窗: baseline to post-intervention (Day 11), and at 1-month and 3-month follow-ups
次要结局
未报告次要终点
研究者
BUVANESVARAN S
Armed Forces Medical College
