A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Brain glymphatic function
研究概览
简要总结
The aim of this study was to evaluate the effect of flash stimulation therapy on the function of the cerebral glymphatic system and efficacy of improving symptoms in PD patients.
详细描述
Each subject will receive EEG recordings for two consecutive nights starting at 21:00. Participants will undergo baseline functional magnetic resonance imaging (fMRI). Subsequently, one week of flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) was started, using flash stimulation between 20:00 and 21:00. After the 7-day flash stimulation treatment, a second round of clinical evaluation and fMRI will be performed.
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, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients who meet the diagnostic criteria of the International Movement Disorders Association (MDS), between the ages of 50 and 70 years, the course of disease ≤5 years, and the Hoehn & Yahr stage ≤3;
- •Anti-PD drugs were taken regularly for at least one month before screening, and symptoms were stable;
- •The fixed bedtime in the past month is between 9:00 p.m. and 1:00 a.m., and the total sleep time is ≥6 hours;
- •Have the ability to understand and voluntarily sign informed consent;
- •Have good compliance and are willing to complete all follow-up required by this program.
排除标准
- •Secondary insomnia: including sleep disorders (restless leg syndrome, periodic limb movement disorder, sleep-related breathing disorders, etc.), physical diseases, mental disorders, psychoactive substance abuse;
- •suffering from photosensitive dermatitis, epilepsy and other diseases that are not suitable for flash stimulation;
- •Alcohol, coffee, or drug abusers in the past 6 months;
- •Mental illness: such as anxiety, depression, schizophrenia and post-traumatic stress disorder caused by insomnia;
- •Used drugs or health products that regulate sleep function or affect sleep within 14 days before enrollment or less than 5 drug half-lives;
- •Taking drugs that may impair cognitive ability, such as anticholinergic drugs, memory enhancing drugs, etc., within 7 days before enrollment;
- •the subject is unable to complete the test or follow-up;
- •suffering from other neurodegenerative diseases;
- •There are endoplants in the body that cannot be examined by MRI;
- •Inability to lie flat;
- •Other situations in which the researcher considers it inappropriate to participate in the study.
研究组 & 干预措施
Group1:40Hz flash stimulation
A one-week 40HZ flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00.
干预措施: 40Hz light modulation glasses (Device)
Group2:100Hz flash stimulation
A one-week 100HZ flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00.
干预措施: 100Hz light modulation glasses (Device)
结局指标
主要结局
Brain glymphatic function
时间窗: The first day after treatment
The gBOLD-CSF coupling strength is improved in PD patients treated with 40Hz flash stimulation.
次要结局
- Movement Disorder Society Unified Parkinson's Disease Rating Scale （MDS-UPDRS）(The first day after treatment)
- Parkinson's disease sleep scale（PDSS）(The first day after treatment)
研究者
Zhang Baorong
Chief physician
Second Affiliated Hospital, School of Medicine, Zhejiang University