Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging
研究概览
简要总结
This study is a single center study, led by Dr. Ma Qinying from the Department of Neurology at the First Hospital of Hebei Medical University. This study is an intervention study on plasma stimulation, involving patients with insomnia disorders to observe the effectiveness of plasma stimulation on insomnia disorders. Collect the Hamilton Anxiety Scale, Hamilton Depression Scale, Pittsburgh Sleep Quality Index Scale, Insomnia Severity Index Scale, and Somatization Symptom Self Rating Scale from patients before and after intervention. Transcranial magnetic stimulation synchronous electroencephalogram (TMS-EEG) and functional magnetic resonance imaging data. The research period is from December 2023 to July 2025, and a total of 40 patients are planned to be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years old, gender is not limited;
- •right-handed;
- •the audiovisual level is sufficient to complete the examinations required for the study;
- •No medication for 1 month before enrollment, or stable taking sleep-improving drugs but poor treatment effect;
- •Informed consent signed by the patient or family member.
排除标准
- •Substance abuse/dependence within 6 months prior to enrollment;
- •Have had other mental illnesses within 6 months prior to enrollment;
- •Those with severe or unstable organic diseases;
- •pregnant or lactating women;
- •Those with a score of 3 (suicide) in 17 items of the Hamilton Depression Rating Scale ≥ 3;
- •Those who have participated in any other clinical trials within 1 month before enrollment;
- •In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
结局指标
主要结局
Functional magnetic resonance imaging
时间窗: Before and after 14 day/false stimulation, 20 minutes each time
Functional magnetic resonance imaging (fMRI) is an imaging technique based on blood oxygen level dependence (BOLD), which can display small changes in magnetic resonance signals caused by changes in blood oxygenation status in venous capillaries in various regions of the brain.
Transcranial Magnetic Stimulation Combined Electroencephalography
时间窗: Before and after 14 day/false stimulation, 20 minutes each time
with the advancement of technology, magnetic compatible EEG electrodes and amplifiers have been invented, making it possible to synchronously record undisturbed EEG under transcranial magnetic stimulation. The monitoring technology of transcranial magnetic stimulation combined electroencephalography (TMS-EEG) has also emerged
次要结局
- Pittsburgh Sleep Quality Index Scale(Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation)
- Somatization Symptom Self Rating Scale(Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation)
- Hamilton Anxiety Scale(Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation)
- Insomnia Severity Index Scale(Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation)
- Hamilton Depression Scale(Follow up for 10 minutes before and after 14 days of false stimulation, as well as one month after the completion of true/false stimulation)
研究者
Qinying Ma
chief physician
The First Hospital of Hebei Medical University