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Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scalp Acupuncture
Body Acupenture
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed as Idiopathic Parkinsonism by Neurologist
  2. Have taken first line drugs more than three months
  3. Did not take any acupuncture or rehabilitation
  4. Voluntary

Exclusion Criteria:

  1. Taking anticancer drug now or diagnosed as depression, psychosis or other mental illnesses
  2. Medical history of stroke or dementia
  3. Taking anticoagulant now or having coagulation disorders
  4. Scalp infection
  5. Pregnant women
  6. Patient with irregular heartbeat, implanted artificial cardiac pacemaker or implanted cardioverter-defibrillator
  7. Belonephobia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Therapy Group

    Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Unified Parkinson's Disease Rating Scale
    A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale".The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points.The higher score meand the worse condition. The sum of all the items'score is the score of the scale. Highr Rating Scales'scores indicate severe symptoms.
    Micro Vibration Scan
    Discover early symptom before the onset. Recognize PD tremor pattern within 1 minute. Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.
    SPECT
    A type of nuclear imaging test that shows how blood flows to tissues and organs.
    PET/MRI
    PET/MRI combines time-of-flight PET with 3-Tesla MRI for exceptional image quality, more conclusive diagnosis, and lower radiation in a single exam. The powerful combination of molecular, functional and anatomic information provides essential data for critical treatment decisions.

    Secondary Outcome Measures

    Constitution in Chinese Medicine Questionnaire (CCMQ)
    Sixty items were applied to measure the nine constitutions: Neutral (a normal constitution), Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Stagnant-blood constitution, Stagnant-Qi constitution, and Inherited-special constitution.
    Sphygmograph
    Diagnoses patient's pulse change

    Full Information

    First Posted
    January 1, 2019
    Last Updated
    January 22, 2019
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03791983
    Brief Title
    Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease
    Official Title
    Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease -The Evaluation of Scalp Acupuncture for Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Veterans General Hospital, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study integrates traditional Chinese medicine syndromes and pulse diagnosis, and uses laser vibration overlay and functional cerebral angiography to understand the efficacy of scalp acupuncture against Parkinson's Disease.
    Detailed Description
    Traditional Chinese medicine does not have the term " Parkinson's disease". According to the symptoms of the disease, it is closer to the "Liver wind", "Vibration" and "Chatter" in Chinese medicine. Scalp needle stimulation can increase the content of dopamine in the brain and improve mitochondrial function and reduce the death of substantia nigra. This study integrates TCM syndromes and pulse diagnosis, and uses laser vibration overlay and functional brain image to understand the effect of scalp acupuncture on Parkinson's disease. The project will be carried out in two phases: the first phase is the pilot study, and 200 patients with limb shakes were collected from the neurology clinic. After the laser vibration overlay test, 20 patients with mild tremors and diagnosed as Parkinson's disease were selected. , treated by Wen's scalp acupuncture. In the second phase, 80 Parkinson patients were enrolled, randomized to the treatment group and the control group, and the changes in TCM syndrome, pulse diagnosis and Parkinson scale were compared before and after treatment, and the fMRI and vibration overlay ratios were evaluated after scalp acupuncture.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapy Group
    Arm Type
    Experimental
    Arm Title
    Control Group
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Scalp Acupuncture
    Intervention Description
    Scalp acupuncture is a form of alternative medicine in which thin needles are inserted into the scalp. It is a key component of traditional Chinese medicine (TCM).
    Intervention Type
    Other
    Intervention Name(s)
    Body Acupenture
    Intervention Description
    Acupuncture is a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine (TCM).
    Primary Outcome Measure Information:
    Title
    Unified Parkinson's Disease Rating Scale
    Description
    A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale".The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points.The higher score meand the worse condition. The sum of all the items'score is the score of the scale. Highr Rating Scales'scores indicate severe symptoms.
    Time Frame
    2 Months
    Title
    Micro Vibration Scan
    Description
    Discover early symptom before the onset. Recognize PD tremor pattern within 1 minute. Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.
    Time Frame
    2 Months
    Title
    SPECT
    Description
    A type of nuclear imaging test that shows how blood flows to tissues and organs.
    Time Frame
    2 Months
    Title
    PET/MRI
    Description
    PET/MRI combines time-of-flight PET with 3-Tesla MRI for exceptional image quality, more conclusive diagnosis, and lower radiation in a single exam. The powerful combination of molecular, functional and anatomic information provides essential data for critical treatment decisions.
    Time Frame
    2 Months
    Secondary Outcome Measure Information:
    Title
    Constitution in Chinese Medicine Questionnaire (CCMQ)
    Description
    Sixty items were applied to measure the nine constitutions: Neutral (a normal constitution), Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Stagnant-blood constitution, Stagnant-Qi constitution, and Inherited-special constitution.
    Time Frame
    2 Months
    Title
    Sphygmograph
    Description
    Diagnoses patient's pulse change
    Time Frame
    2 Months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as Idiopathic Parkinsonism by Neurologist Have taken first line drugs more than three months Did not take any acupuncture or rehabilitation Voluntary Exclusion Criteria: Taking anticancer drug now or diagnosed as depression, psychosis or other mental illnesses Medical history of stroke or dementia Taking anticoagulant now or having coagulation disorders Scalp infection Pregnant women Patient with irregular heartbeat, implanted artificial cardiac pacemaker or implanted cardioverter-defibrillator Belonephobia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang-Pei Chen, MD
    Phone
    0228757454
    Email
    fpchen@vghtpe.gov.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang-Pei Chen, MD
    Organizational Affiliation
    Taipei Veterans General Hospital, Taiwan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease

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