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

NCT ID: NCT03501004

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-09-30

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.

Conditions

Acupuncture; Parkinson's Disease; Sleep Disorders; Neuroimaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The Acupuncture Group

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).

Group Type: EXPERIMENTAL

Sterile acupuncture needles for single use

Intervention Type: 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.

The Sham Acupuncture Group

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.

Group Type: SHAM_COMPARATOR

Sterile acupuncture needles for single use

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tsinghua University

OTHER

Sponsor Role: lead

Responsible Party

Yu Ma

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuqi Zhang

Role: STUDY_CHAIR

Tsinghua University Yuquan Hospital

Locations

Tsinghua University Yuquan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

QHDXYQYY20180001

Identifier Type: -

Identifier Source: org_study_id