The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders

Conditions
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Acupuncture, Parkinson's Disease, Sleep Disorders, Neuroimaging

Intervention / Treatment
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* Device: Sterile acupuncture needles for single use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting the above diagnostic criteria for Parkinson's disease and Sleep Disorders; Hoehn-Yahr grade 2-3; Those who voluntarily participate in the project while he/she or his/her guardian sign an informed consent form; Those who have had a junior high school education or above and have a correct understanding of clinical acupuncture research significance. Exclusion Criteria: Accompanied with sleep apnea syndrome, sleep-behavioral disorders such as sleep-breathing disorders, and other system diseases that cause sleep disorders, such as anemia and other hematological diseases, hypothyroidism, severe heart and lung diseases, tumors, liver and kidney diseases; History of drug use or alcohol addiction, psychosis and sedation for painful illnesses; Severe cognitive impairments and failure to complete scale assessments; There are barriers to communication and communication that affect the evaluation of research, such as speech, vision, hearing and other serious damage to patients; Allergic to needles or alcohol; Those who cannot perform MRI scans, such as claustrophobia.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Acupuncture Group<br>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). | Device: Sterile acupuncture needles for single use<br>* Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm.<br>|
| Sham Comparator: The Sham Acupuncture Group<br>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. | Device: Sterile acupuncture needles for single use<br>* Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow data change | Neuroimaging assessment by 3D SNAP-MRA | Through once acupuncture completion, 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |