NCT03791983

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable parkinson-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

January 1, 2019

Last Update Submit

January 22, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

  • 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

  • Micro Vibration Scan

    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.

    2 Months

  • SPECT

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

    2 Months

  • 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 Outcomes (2)

  • Constitution in Chinese Medicine Questionnaire (CCMQ)

    2 Months

  • Sphygmograph

    2 Months

Study Arms (2)

Therapy Group

EXPERIMENTAL
Other: Scalp Acupuncture

Control Group

OTHER
Other: Body Acupenture

Interventions

Scalp AcupunctureOTHER

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).

Therapy Group
Body AcupentureOTHER

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).

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Fang-Pei Chen, MD

    Taipei Veterans General Hospital, Taiwan

    STUDY CHAIR

Central Study Contacts

Fang-Pei Chen, MD

CONTACT

0228757454fpchen@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 3, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 24, 2019

Record last verified: 2019-01