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The purpose of the study is to compare vascular and functional neurological changes of acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints GV14(Dazhui)and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14(Dazhui)and GB20 (Fengchi) in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the study, researchers will observe changes in cerebral blood vessels and neuroimaging before and after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal imaging techniques could evaluate the effect of acupuncture on brain blood vessels and function in patients with Parkinson's disease and Sleep Disorders and provide an objective neuroimaging basis for assessing the effectiveness of acupuncture.
Neuroimaging assessment:Subjects are keeping awake, resting flat on the examination table, using rubber earplugs to reduce noise, using foam headbands to fix head movement artifacts, closing eyes to calm breathing, fixing the head and minimizing head and other parts of the initiative and passive exercise.At the same time, it is required not to carry out any thinking activities. After the subject is familiar with the environment, it begins to scan and conduct a comprehensive MRI scan before and after the acupuncture needling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Acupuncture Group | Experimental | Sterile acupuncture needles for single use will be used.The intervention is going to be executed using the acupuncture points GV14(Dazhui)and GB20 (Fengchi) for 20 minutes.The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14(Dazhui)and GB20 (Fengchi). |
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| The Sham Acupuncture Group | Sham Comparator | Sterile acupuncture needles for single use will be used.The sham acupuncture group's acupuncture needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points for 20 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile acupuncture needles for single use | Device | Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow data change | Neuroimaging assessment by 3D SNAP-MRA | Through once acupuncture completion, 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Disease Sleep Scale | Scale evaluation.Scale Range:0-150.Higher values represent a better outcome. | Through once acupuncture completion, 30 minutes |
| Pittsburgh Sleep Quality Index | Scale evaluation.Scale Range:0-21.Higher values represent a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuqi Zhang | Tsinghua University Yuquan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsinghua University Yuquan Hospital | Beijing | Beijing Municipality | 100000 | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 12 months of study completion.
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Through once acupuncture completion, 30 minutes |
| Epworth Sleepiness Scale | Scale evaluation.Scale Range:0-24.Higher values represent a worse outcome. | Through once acupuncture completion, 30 minutes |
| Unified Parkinson's Disease Rating Scale | Scale evaluation.Scale Range:0-149.Higher values represent a worse outcome. | Through once acupuncture completion, 30 minutes |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |