Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change of Motor Function in PD by Low Frequency rTMS Stimulation
研究概览
简要总结
At present, no drug therapy has been proven to delay the progression of Parkinson's disease (PD). rTMS, as a non-invasive neuromodulation method, can regulate Slow-wave sleep (SWS). SWS is recognized closely related to neurodegeneration. However, there has been no clinical studies on if rTMS could delay the progression of PD by regulating SWS.
The main purpose of this study is to explore the changes of SWS in non-rapid eye movement (NREM) sleep period in PD patients by using rTMS, and the relationship with potential improvements of SWS and motor symptom delay. The study aims to find a potential new treatment strategy to delay the neurodegenerative process in PD patients by modulating SWS by rTMS.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
- •Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female.
- •Hoehn-Yahr stages 1-
- •The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
- •Right-handed.
- •The patient signed a written informed consent.
排除标准
- •Any form of Parkinsonism other than primary PD.
- •Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
- •Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
- •Persons with mental disabilities.
- •Pregnant women.
- •There are contraindications for rTMS treatment.
- •There are contraindications for MRI examination.
- •Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI>=
- •Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure.
- •Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study.
结局指标
主要结局
Change of Motor Function in PD by Low Frequency rTMS Stimulation
时间窗: Day14
the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)\[off\] The higher the score, the more severe the motor dysfunction
次要结局
- Effects of low-frequency rTMS stimulation on motor symptoms(Day28,Day56)
- Effects of low-frequency rTMS stimulation on anxiety(Day14,Day28,Day56)
- Measurement of improved balance function in patients with Parkinson's disease(Day14,Day28,Day56)
- Assessment of sleep structure in patients with Parkinson's disease(Day14,Day28,Day56)
- Assessment of daytime sleepiness in patients with Parkinson's disease(Day14,Day28,Day56)
- Effects of low-frequency rTMS stimulation on cognition(Day14,Day28,Day56)
- Effects of low-frequency rTMS stimulation on cortical excitability(Day14,Day28)
- Effects of low-frequency rTMS stimulation on depression(Day14,Day28,Day56)
- Effects of low-frequency rTMS stimulation on gait(Day14,Day28,Day56)
研究者
Xiaoying Zhu
associate chief physician of neurology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine