A Randomized Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Anxiety Spectrum Disorders
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The primary outcome measure is pre-post change in total HAM-A scores and asses efficacy as compared to sham stimulation
研究概览
简要总结
Anxiety disorders are highly prevalent and disabling conditions where existing first-line interventions have limited efficacy and accessibility alongside side effects. Non-invasive brain stimulation with rTMS represents a safe, well-tolerated alternative approach that has shown initial promise but lacks adequately powered sham-controlled evidence. The study aims to conclusively establish the efficacy, tolerability and neurophysiological correlates of right prefrontal high-frequency rTMS in adults with moderate to severe anxiety unresponsive to standard treatment.
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 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Principal Diagnosis of Panic disorder, phobic disorder and GAD as per ICD 10 criteria.
- •2.Moderate to severe anxiety (HAM-A ≥20) 3.Along with pharmacotherapy (as per IPS guidelines) rTMS / Sham rTMS.
排除标准
- •Current high suicide risk Comorbid MDD, OCD, psychotic disorders, bipolar spectrum or substance use disorders Neurological disorders like cerebrovascular disease or epilepsy Patient on mood stabiliser,Medical comorbidities or pregnancy and Other contraindications to rTMS like pacemakers or head implants.
结局指标
主要结局
The primary outcome measure is pre-post change in total HAM-A scores and asses efficacy as compared to sham stimulation
时间窗: At 2nd and 4th week
次要结局
- Treatment response & remission rated(Treatment response rate (≥50% HAM-A reduction), remission rate (HAM-A score ≤7), changes in WHODAS scores & frequency of adverse events at 2nd week)
研究者
Tanya Dixit
Kalinga Institute Of Medical Sciences Hospital and College , Bhubaneswar.