Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease

NCT ID: NCT03791983

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2021-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapy Group

Group Type: EXPERIMENTAL

Scalp Acupuncture

Intervention Type: OTHER

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

Group Type: OTHER

Body Acupenture

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang-Pei Chen, MD

Role: STUDY_CHAIR

Taipei Veterans General Hospital, Taiwan

Central Contacts

Fang-Pei Chen, MD

Role: CONTACT

fpchen@vghtpe.gov.tw

0228757454

Other Identifiers

2018-10-002B

Identifier Type: -

Identifier Source: org_study_id