Parkinson DiseaseNCT03791983
Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease
A study testing Scalp Acupuncture and Body Acupenture in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Scalp Acupuncture and Body Acupenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed as Idiopathic Parkinsonism by Neurologist
- Have taken first line drugs more than three months
- Did not take any acupuncture or rehabilitation
- Voluntary
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease -The Evaluation of Scalp Acupuncture for Parkinson's Disease
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.
Read the 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
- Being tested
- Scalp Acupuncture, Body Acupenture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Therapy Group | Experimental | Not described Receives: Other: Scalp Acupuncture |
| Control Group | Other | Not described Receives: Other: Body Acupenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Months
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.
Measured: 2 Months
SPECT
A type of nuclear imaging test that shows how blood flows to tissues and organs.
Measured: 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.
Measured: 2 Months
Secondary outcomes (2)
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.
Measured: 2 Months
Sphygmograph
Diagnoses patient's pulse change
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fang-Pei Chen, MD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791983
- Sponsor's protocol ID
- 2018-10-002B
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease -The Evaluation of Scalp Acupuncture for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03791983
- Acronym / sponsor ID
- 2018-10-002B
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Feb 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy Group | Experimental | Other: Scalp Acupuncture |
| Control Group | Other | Other: Body Acupenture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as Idiopathic Parkinsonism by Neurologist
- Have taken first line drugs more than three months
- Did not take any acupuncture or rehabilitation
- Voluntary
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp AcupunctureScalp 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 | Therapy Group |
| Body AcupentureAcupuncture 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). | Other | Control Group |
Primary outcome
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
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.
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.
2 secondary outcomes
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: 2 Months
Sphygmograph
Time frame: 2 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang-Pei Chen, MD study chair
Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Scalp Acupuncture and Body Acupenture in people with Parkinson Disease, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang-Pei Chen, MD (0228757454, fpchen@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (time frame: 2 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.