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NCT Number: NCT03501004

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

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.

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Key information

Conditions

Acupuncture Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neuroimaging Neurologic Manifestations Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders Synucleinopathies

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tsinghua University Yuquan Hospital

Beijing, Beijing Municipality, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sterile acupuncture needles for single use

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.

Primary outcomes

  1. Cerebral blood flow data change

    Time frame: Through once acupuncture completion, 30 minutes

    Neuroimaging assessment by 3D SNAP-MRA

Secondary outcomes

  1. Parkinson's Disease Sleep Scale

    Time frame: Through once acupuncture completion, 30 minutes

    Scale evaluation.Scale Range:0-150.Higher values represent a better outcome.

  2. Pittsburgh Sleep Quality Index

    Time frame: Through once acupuncture completion, 30 minutes

    Scale evaluation.Scale Range:0-21.Higher values represent a worse outcome.

  3. Epworth Sleepiness Scale

    Time frame: Through once acupuncture completion, 30 minutes

    Scale evaluation.Scale Range:0-24.Higher values represent a worse outcome.

  4. Unified Parkinson's Disease Rating Scale

    Time frame: Through once acupuncture completion, 30 minutes

    Scale evaluation.Scale Range:0-149.Higher values represent a worse outcome.

Sponsors and collaborators

Lead sponsor

Tsinghua University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2018
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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