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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501004
• Other study ID #: QHDXYQYY20180001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2021
• Source: Tsinghua University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Neuroimaging
• Parasomnias
• Parkinson Disease
• Parkinson's Disease
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Device:
• Sterile acupuncture needles for single use
Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm.

Locations

Country	Name	City	State
China	Tsinghua University Yuquan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow data change	Neuroimaging assessment by 3D SNAP-MRA	Through once acupuncture completion, 30 minutes
Secondary	Parkinson's Disease Sleep Scale	Scale evaluation.Scale Range:0-150.Higher values represent a better outcome.	Through once acupuncture completion, 30 minutes
Secondary	Pittsburgh Sleep Quality Index	Scale evaluation.Scale Range:0-21.Higher values represent a worse outcome.	Through once acupuncture completion, 30 minutes
Secondary	Epworth Sleepiness Scale	Scale evaluation.Scale Range:0-24.Higher values represent a worse outcome.	Through once acupuncture completion, 30 minutes
Secondary	Unified Parkinson's Disease Rating Scale	Scale evaluation.Scale Range:0-149.Higher values represent a worse outcome.	Through once acupuncture completion, 30 minutes