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Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03791983
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Scalp Acupuncture Other: Body Acupenture Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease ─The Evaluation of Scalp Acupuncture for Parkinson's Disease
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapy Group Other: Scalp Acupuncture
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).

Control Group Other: Body Acupenture
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 Measures :
  1. Unified Parkinson's Disease Rating Scale [ Time Frame: 2 Months ]
    A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's.

  2. Micro Vibration Scan [ Time Frame: 2 Months ]
    1. Discover early symptom before the onset.
    2. Recognize PD tremor pattern within 1 minute.
    3. Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.

  3. SPECT [ Time Frame: 2 Months ]
    A type of nuclear imaging test that shows how blood flows to tissues and organs.

  4. PET/MRI [ Time Frame: 2 Months ]
    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 :
  1. Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 2 Months ]
    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.

  2. Sphygmograph [ Time Frame: 2 Months ]
    Diagnoses patient's pulse change



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03791983


Contacts
Contact: Fang-Pei Chen, MD 0228757454 fpchen@vghtpe.gov.tw

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Study Chair: Fang-Pei Chen, MD Taipei Veterans General Hospital, Taiwan

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03791983     History of Changes
Other Study ID Numbers: 2018-10-002B
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases