Effectiveness of Transcranial Direct Current Stimulation in Craving Reduction and Relapse prevention in patients with Alcohol Dependence Syndrome - A Randomised Sham Controlled Study with Genetic Expression Profiling Analysis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in alcohol craving scores as measured by the Obsessive Compulsive Drinking Scale(OCDS).
研究概览
简要总结
This is a single-center, single-blind, randomized sham-controlled clinical trial conducted at a tertiary mental health institute in India. The study aims to evaluate the clinical efficacy of transcranial direct current stimulation (tDCS) in reducing craving and preventing relapse in male patients diagnosed with Alcohol Dependence Syndrome (ADS) as per ICD-11 criteria. In addition to clinical outcomes, the study will also investigate molecular changes by analyzing the gene expression of GRIN2B and GRIA1, which are associated with craving and neuroplasticity. Participants will be randomly assigned to receive either active or sham tDCS over 10 sessions within 14 days. Craving will be measured using the Obsessive Compulsive Drinking Scale (OCDS), and blood samples will be collected at baseline, post-intervention, and one-month follow-up to assess gene expression changes. The study hypothesizes that active tDCS will lead to a significant reduction in craving and relapse rates and result in favorable modulation of target gene expression compared to sham stimulation.
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 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients aged between 18 and 55 years.
- •Diagnosed with Alcohol Dependence Syndrome as per ICD
- •CIWA Ar score less than or equal to 10 at admission.
- •Not currently receiving anti craving medications.
- •OCDS score greater than
- •Willing to provide informed consent and comply with study procedures.
排除标准
- •a) Patients who do not give informed consent for the study.
- •b) Patients with any other substance use disorder other than nicotine.
- •c) Patients who have received modified electroconvulsive therapy (mECT) or any other neuromodulation treatment in the past 6 months.
- •d) Patients with any significant neurological illness.
- •e) Presence of medical implants (e.g., pacemakers, defibrillators, brain aneurysm clips, cochlear implants).
- •f) Patients with any other contraindications to tDCS, including migraine and scalp skin lesions.
结局指标
主要结局
Reduction in alcohol craving scores as measured by the Obsessive Compulsive Drinking Scale(OCDS).
时间窗: Baseline, 2 Weeks, 1 month post-intervention.
次要结局
- Relapse rate in patients with Alcohol Dependence Syndrome.(1 month post intervention)
- Change in gene expression levels (GRIN2B and GRIA1) from baseline to post-tDCS and follow-up(Baseline, post tDCS intervention, 1 month post intervention.)
- Improvement in quality of life scores(1 month post-intervention)
研究者
Dr. Rajath Kumar K
DHARWAD INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, DIMHANS