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

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ClinicalTrials.gov Identifier: NCT03501004
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yu Ma, 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.

Condition or disease Intervention/treatment Phase
Acupuncture Parkinson's Disease Sleep Disorders Neuroimaging Device: Sterile acupuncture needles for single use Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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.

Sham Comparator: 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.
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.




Primary Outcome Measures :
  1. Cerebral blood flow data change [ Time Frame: Through once acupuncture completion, 30 minutes ]
    Neuroimaging assessment by 3D SNAP-MRA


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501004


Contacts
Contact: Yuan Yang 8613051918819 ciisy198811@163.com
Contact: Yu Ma 8613501085569 lymayu@163.com

Sponsors and Collaborators
Tsinghua University
Investigators
Study Chair: Yuqi Zhang Tsinghua University Yuquan Hospital

Responsible Party: Yu Ma, Associate Professor, Tsinghua University
ClinicalTrials.gov Identifier: NCT03501004     History of Changes
Other Study ID Numbers: QHDXYQYY20180001
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 12 months of study completion.
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Disease
Parkinson Disease
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders