Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03791983
• Other study ID #: 2018-10-002B
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Fang-Pei Chen, MD
• Phone: 0228757454
• Email: fpchen[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 Months
Primary	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.	2 Months
Primary	SPECT	A type of nuclear imaging test that shows how blood flows to tissues and organs.	2 Months
Primary	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.	2 Months
Secondary	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.	2 Months
Secondary	Sphygmograph	Diagnoses patient's pulse change	2 Months