Effect of 1Hz repetitive, deep transcranial magnetic stimulation (dTMS) over right Inferior Frontal gyrus, right Anterior Insula on Craving, Heart Rate Variability and Cognitive Performance in Heroin Dependent Users – A Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in subjective report of craving measured using the Desire for Drug Questionnaire (DDQ) and Verbal Analogue Scale (VAS)
研究概览
简要总结
Previous study at our centre found hyperactivation of right inferior frontal gyrus and right anterior insula when heroin dependent users experienced craving on exposure to I-CARE cues. Use of DCC over rIFG might offer to let the induced electrical pulses reach the immediately underlying rAI. Simultaneous inhibition of these two adjacent cortical regions with the help of 1Hz dTMS when exposed to heroin-related cues, will cause decrease in subjective report of craving (DDQ, VAS) and decrease in the sympathetic tone on HRV during I-CARE paradigm, an objective measure of craving. Better inhibitory function of rIFG and rAI might improve decision making on CGT and inhibition of undesired response on SST, the two key cognitive impairments implicated in Craving and relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a diagnosis of moderate to severe Heroin use disorder by the Diagnostic and Statistical Manual of Mental Disorders -5 (DSM-5)
- •Score greater than or equal to 4 on VAS
- •Providing written informed consent.
排除标准
- •Patients with neurological disorders like multiple sclerosis, stroke, epilepsy, encephalopathy due to any cause
- •Patients with a history of significant head injury, brain tumour or any brain surgery
- •Patients with primary psychotic or mood disorder or other substance use disorder except nicotine
- •Pregnant and lactating females
- •Any electronic or metal implants
- •Any contraindications for TMS as assessed by the TMS Adult Safety Screen (TASS).
结局指标
主要结局
Change in subjective report of craving measured using the Desire for Drug Questionnaire (DDQ) and Verbal Analogue Scale (VAS)
时间窗: Assessments will be performed at baseline (Day 0), Immediately after the end of 20 twice-daily rTMS sessions (Day 10), and at 4 weeks, i.e., 28 days after the termination of rTMS course (Day 38)
次要结局
- Change in an objective measure of craving using heroin visual image cue-elicited HRV measures, consumption of heroin measured using timeline follow back (TLFB), decision-making abilities and response inhibition assessed on CGT and SST, respectively.(Secondary endpoint (Day 38): 4 weeks i.e., 28 days after the termination of 20 rTMS sessions)
研究者
Shalini Naik
Postgradute Institute of Medical Education and Research