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

Not Applicable

Completed

• Conditions: Acupuncture; Neuroimaging; Sleep Disorders; Parkinson's Disease
• Interventions: Device: Sterile acupuncture needles for single use

• Registration Number: NCT03501004
• Lead Sponsor: Tsinghua University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-18
• Study Start: 2018-06-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. meeting the above diagnostic criteria for Parkinson's disease and Sleep Disorders;
2. Hoehn-Yahr grade 2-3;
3. Those who voluntarily participate in the project while he/she or his/her guardian sign an informed consent form;
4. Those who have had a junior high school education or above and have a correct understanding of clinical acupuncture research significance.

Exclusion Criteria

1. 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;
2. History of drug use or alcohol addiction, psychosis and sedation for painful illnesses;
3. Severe cognitive impairments and failure to complete scale assessments;
4. There are barriers to communication and communication that affect the evaluation of research, such as speech, vision, hearing and other serious damage to patients;
5. Allergic to needles or alcohol;
6. Those who cannot perform MRI scans, such as claustrophobia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The Acupuncture Group	Sterile acupuncture needles for single use	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).
The Sham Acupuncture Group	Sterile acupuncture needles for single use	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.

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow data change	Through once acupuncture completion, 30 minutes	Neuroimaging assessment by 3D SNAP-MRA

Secondary Outcome Measures

Name	Time	Method
Parkinson's Disease Sleep Scale	Through once acupuncture completion, 30 minutes	Scale evaluation.Scale Range:0-150.Higher values represent a better outcome.
Pittsburgh Sleep Quality Index	Through once acupuncture completion, 30 minutes	Scale evaluation.Scale Range:0-21.Higher values represent a worse outcome.
Epworth Sleepiness Scale	Through once acupuncture completion, 30 minutes	Scale evaluation.Scale Range:0-24.Higher values represent a worse outcome.
Unified Parkinson's Disease Rating Scale	Through once acupuncture completion, 30 minutes	Scale evaluation.Scale Range:0-149.Higher values represent a worse outcome.

Trial Locations

Locations (1)

Tsinghua University Yuquan Hospital; 🇨🇳 Beijing, Beijing, China