“Efficacy And Safety Of Continuous Theta Burst Stimulation Over Dorsolateral Prefrontal Cortex In Insomnia Disorder: A Randomized Sham Controlled Trialâ€
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess efficacy and safety of continuous theta burst stimulation over dorsolateral prefrontal cortex in insomnia disorder: a Randomized sham controlled trial
研究概览
简要总结
Insomnia disorder include early morning awakening, trouble falling asleep, low-quality sleep. For Sample size:As per a recent meta-analysis, the effect size of transcranial magnetic stimulation in sleep quality in primary insomnia is 0.90 . Thereby, targeting at least modest effect size of power 0.95, alpha error probability is 0.05, the number of groups is 2, and the number of measurements being 3, with a 25% dropout rate, we applied the G*Power tool, with the statistical test being ANOVA: total sample size of 30. (15 active and 15 sham). Through our study we aim at investigating the efficacy and safety of continuous theta bursts stimulation over dorsolateral prefrontal cortex in insomnia disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with a diagnosis of INSOMNIA DISORDER based on the diagnostic criteria of diagnostic and statistical manual of mental disorder, fifth edition (DSM 5) 2)Screening cut-off less than 16 as per Sleep condition indicator (SCI) 3)Patients aged above 18 years. 4)Patient willing to participate in the study and give written consent for the same.
排除标准
- •1.Patient is uncooperative for the procedure.
- •2.Patients with neurological disorders with history of epilepsy, organic brain damage or any neurological procedures 3.Patients with implanted metallic devices 4.Patients receiving ECT in past 6 months.
- •5.Patients with significant unstable medical conditions like uncontrolled hypertension, complicated diabetes mellitus, organic failures, etc.
- •6.Pregnant and lactating female.
- •7.Patient with mental disorder except comorbid major depressive disorder and anxiety disorders as per DSM-5 (APA, 2013) 8.Any co-morbid current substance use disorders except nicotine and caffeine as per DSM-5 (APA, 2013).
结局指标
主要结局
To assess efficacy and safety of continuous theta burst stimulation over dorsolateral prefrontal cortex in insomnia disorder: a Randomized sham controlled trial
时间窗: PSQI, ISI, FOSQ-10 and WHOQOL-BREF scores will be assessed at baseline, 10th day and 25th day.
次要结局
- To compare the pre-post changes in subjective sleep parameters, quality of life and safety in patients suffering from insomnia disorder following active continuous theta burst stimulation and sham continuous theta burst stimulation.(PSQI, ISI, FOSQ-10 and WHOQOL-BREF scores will be assessed at baseline, 10th day and 25th day.)
研究者
Dr Shobit Garg
Sri Guru Ram Rai Institute Of Medical and Health Sciences