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临床试验/NCT03791983
NCT03791983Unknown不适用

Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease -The Evaluation of Scalp Acupuncture for Parkinson's Disease

Taipei Veterans General Hospital, Taiwan0 个研究点目标入组 200 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
Unified Parkinson's Disease Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed as Idiopathic Parkinsonism by Neurologist
  • Have taken first line drugs more than three months
  • Did not take any acupuncture or rehabilitation

排除标准

  • 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

研究组 & 干预措施

Therapy Group

Experimental

干预措施: Scalp Acupuncture (Other)

Control Group

Other

干预措施: Body Acupenture (Other)

结局指标

主要结局

Unified Parkinson's Disease Rating Scale

时间窗: 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.

SPECT

时间窗: 2 Months

A type of nuclear imaging test that shows how blood flows to tissues and organs.

Micro Vibration Scan

时间窗: 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.

PET/MRI

时间窗: 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.

次要结局

  • Constitution in Chinese Medicine Questionnaire (CCMQ)(2 Months)
  • Sphygmograph(2 Months)

研究者

申办方类型
Other Gov
责任方
Sponsor

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