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
About this trial
This is an interventional treatment trial for Parkinson Disease
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
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
NCT ID
NCT03791983
First Posted
January 1, 2019
Last Updated
January 22, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
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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