NCT03501004

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Tsinghua University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-06-30
• Completion: 2020-09-30
• First posted: 2018-04-18
• Last updated: 2021-04-12

Locations

1 site across 1 country: China