Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
2021年3月20日 更新者：Lili Cao、Qianfoshan Hospital
Study on the Mode and Mechanism of Ultra-low Frequency Repetitive Transcranial Magnetic Stimulation for Sleep Disorders in Patients With Parkinson's Disease
The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
研究概览
地位
未知
详细说明
Parkinson's disease is the second most common chronic neurodegenerative disease.At present, researchers focus not only on the motor symptoms of Parkinson's disease, but also on the non-motor symptoms of Parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).The principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by Faraday.
When an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
研究类型
介入性
注册 (预期的)
99
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Shandong
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Jinan、Shandong、中国
- The First Affiliated Hospital of Shandong First Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- in line with international Movement disorders association (the Movement Disorder Society, MDS) in 2015 the diagnosis of Parkinson's disease diagnosis standard and China standard (2016)
- can cooperate to complete rating scale, the sleep monitoring, imaging and blood test
- have a sleep disorder
- aged 18 to 70 years old
- agree to participate in this experiment, and have signed the informed consent
Exclusion Criteria:
- superposition of diagnosed with Parkinson's syndrome
- secondary diagnosed Parkinson's syndrome
- is equipped with heart pacemakers and other metal implants
- cannot achieve scale assessment
- has significant malignant diseases
- has a history of seizures
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation
The study used 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS.
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Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
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有源比较器：GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation
The study used GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS
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Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
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假比较器：the control group
The instrument is not working, only in exhaust mode.
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Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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change from length of sleep at one week
大体时间：one week
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Sleep duration was monitored by polysomnography.It's measured in minutes.
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one week
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change from ratio of stage 3 sleep in total sleep at one week
大体时间：one week
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The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.
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one week
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change from limb movement of sleep at one week
大体时间：one week
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The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.
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one week
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change from nocturnal arousal frequency at one week
大体时间：one week
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The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.
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one week
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change from Pittsburgh sleep quality index scale at one week
大体时间：1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 2L, and the higher the score, the worse the sleep quality.
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1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
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Interleukin 6
大体时间：1 day before treatment and 1 day after treatment
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It plays an important role in central nervous system diseases.
In PD, the increase of IL-6 is the body's self-defense mechanism to protect neurons, and the change of IL-6 in peripheral blood can reflect the change of injury aggravation and recovery.It is also associated with psychiatric symptoms, and IL-6 is elevated in major depression.
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1 day before treatment and 1 day after treatment
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change from the Epworth sleepiness scale at one week
大体时间：one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The scale has an overall score range of 0 to 24, with higher scores indicating more severe sleepiness.
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one week
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change from Parkinson's disease sleep scale at one week
大体时间：one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 150.
The higher the score, the better the sleep.
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one week
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change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
大体时间：one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 260, and the higher the score, the more severe the symptoms were.
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one week
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change from Parkinson's disease quality of life scale one week
大体时间：one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 156, and the higher the score, the worse the quality of life.
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one week
|
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change from Hamilton depression scale at one week
大体时间：one week
|
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 96, and the higher the score, the more severe the depression was.
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one week
|
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change from Hamilton anxiety scale at one week
大体时间：one week
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The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 56, and the higher the score, the more serious the anxiety.
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one week
|
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change from simple mental state scale at one week
大体时间：one week
|
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
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one week
|
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change from Montreal cognitive assessment scale at one week
大体时间：one week
|
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
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one week
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change from magnetic resonance imaging of the brain at one month
大体时间：one month
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The ADC values of sleep-related brain tissues were measured by diffusion weighted magnetic resonance imaging of the brain.Compare the difference between the measured results on both sides of the same site and record the difference.
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one month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xiuhua Li, MD、Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年12月20日
初级完成 (预期的)
2021年12月20日
研究完成 (预期的)
2022年4月20日
研究注册日期
首次提交
2021年3月8日
首先提交符合 QC 标准的
2021年3月15日
首次发布 (实际的)
2021年3月18日
研究记录更新
最后更新发布 (实际的)
2021年3月24日
上次提交的符合 QC 标准的更新
2021年3月20日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.