Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation Based on vlPFC-VTA Individualized Functional Connectivity Localization for the Treatment of Post-stress Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment
研究概览
简要总结
This is a randomized, double-blind controlled study that recruited patients with insomnia problems after suffering a stressful event to undergo individualized transcranial magnetic stimulation
详细描述
This is a randomized, double-blind controlled study that will recruit patients who have experienced a stressful event and currently exhibit severe sleep problems for transcranial magnetic stimulation. They will be randomly assigned to the trial and control groups and will receive 5 consecutive days of continuous theta-wave stimulation, and before and after the treatment they will be assessed on clinical scales and undergo magnetic resonance examinations as well as sleep monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18 and 60 (both 18 and 60) and of any gender;
- •Experienced a severe traumatic event;
- •Stanford Acute Stress Reaction Questionnaire (SASRQ) ≥40 points;
- •PSQI > 7 points;
- •Good compliance and willingness to undergo this therapy.
排除标准
- •Sleep disorders that can be explained by a primary illness;
- •Concurrent psychotherapy;
- •Those with contraindications to magnetic resonance examination and transcranial magnetic stimulation therapy;
- •Combined with serious cardiovascular, hepatic, renal, digestive, hematopoietic system and other primary diseases.
结局指标
主要结局
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to post-treatment
时间窗: Baseline and treatment day 5
The Pittsburgh Sleep Quality Index, compiled in 1989 by Dr. Buysse, a psychiatrist at the University of Pittsburgh, and others. It is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 5 Score -Baseline Score).
次要结局
- Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to treatment day 5(Baseline and treatment day 5)
- Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to treatment day 5(Baseline and treatment day 5)
- Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 5 Score(Baseline and treatment day 5)
- Change in Hamilton Anxiety Scale scores from baseline to treatment day 5 Score(Baseline and treatment day 5)
- Change in Posttraumatic Stress Disorder Check List for Diagnostic and Statistical Manual of Mental Disorders-5 scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Stanford Acute Stress Reaction Questionnaire (SASRQ) scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)