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 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: Scalp Acupuncture Other: Body Acupenture||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|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 :||February 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
|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).
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).
- Unified Parkinson's Disease Rating Scale [ Time Frame: 2 Months ]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 [ Time Frame: 2 Months ]
- 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 [ Time Frame: 2 Months ]A type of nuclear imaging test that shows how blood flows to tissues and organs.
- 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.
- 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.
- Sphygmograph [ Time Frame: 2 Months ]Diagnoses patient's pulse change
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
|Contact: Fang-Pei Chen, MDfirstname.lastname@example.org|
|Study Chair:||Fang-Pei Chen, MD||Taipei Veterans General Hospital, Taiwan|