<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03791983</url>
  </required_header>
  <id_info>
    <org_study_id>2018-10-002B</org_study_id>
    <nct_id>NCT03791983</nct_id>
  </id_info>
  <brief_title>Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease</brief_title>
  <official_title>Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease -The Evaluation of Scalp Acupuncture for Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study integrates traditional Chinese medicine syndromes and pulse diagnosis, and uses&#xD;
      laser vibration overlay and functional cerebral angiography to understand the efficacy of&#xD;
      scalp acupuncture against Parkinson's Disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditional Chinese medicine does not have the term &quot; Parkinson's disease&quot;. According to the&#xD;
      symptoms of the disease, it is closer to the &quot;Liver wind&quot;, &quot;Vibration&quot; and &quot;Chatter&quot; in&#xD;
      Chinese medicine. Scalp needle stimulation can increase the content of dopamine in the brain&#xD;
      and improve mitochondrial function and reduce the death of substantia nigra.&#xD;
&#xD;
      This study integrates TCM syndromes and pulse diagnosis, and uses laser vibration overlay and&#xD;
      functional brain image to understand the effect of scalp acupuncture on Parkinson's disease.&#xD;
      The project will be carried out in two phases: the first phase is the pilot study, and 200&#xD;
      patients with limb shakes were collected from the neurology clinic. After the laser vibration&#xD;
      overlay test, 20 patients with mild tremors and diagnosed as Parkinson's disease were&#xD;
      selected. , treated by Wen's scalp acupuncture. In the second phase, 80 Parkinson patients&#xD;
      were enrolled, randomized to the treatment group and the control group, and the changes in&#xD;
      TCM syndrome, pulse diagnosis and Parkinson scale were compared before and after treatment,&#xD;
      and the fMRI and vibration overlay ratios were evaluated after scalp acupuncture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale</measure>
    <time_frame>2 Months</time_frame>
    <description>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 &quot;evaluation of mentation, behavior, and mood&quot;, &quot;self-evaluation of the activities of daily life&quot;, &quot;clinician-scored monitored motor evaluation&quot;, &quot;complications of therapy&quot;, &quot;Hoehn and Yahr staging of severity of Parkinson's disease&quot; and &quot;Schwab and England ADL scale&quot;.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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Micro Vibration Scan</measure>
    <time_frame>2 Months</time_frame>
    <description>Discover early symptom before the onset.&#xD;
Recognize PD tremor pattern within 1 minute.&#xD;
Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SPECT</measure>
    <time_frame>2 Months</time_frame>
    <description>A type of nuclear imaging test that shows how blood flows to tissues and organs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PET/MRI</measure>
    <time_frame>2 Months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Constitution in Chinese Medicine Questionnaire (CCMQ)</measure>
    <time_frame>2 Months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sphygmograph</measure>
    <time_frame>2 Months</time_frame>
    <description>Diagnoses patient's pulse change</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scalp Acupuncture</intervention_name>
    <description>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).</description>
    <arm_group_label>Therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Body Acupenture</intervention_name>
    <description>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).</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed as Idiopathic Parkinsonism by Neurologist&#xD;
&#xD;
          2. Have taken first line drugs more than three months&#xD;
&#xD;
          3. Did not take any acupuncture or rehabilitation&#xD;
&#xD;
          4. Voluntary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Taking anticancer drug now or diagnosed as depression, psychosis or other mental&#xD;
             illnesses&#xD;
&#xD;
          2. Medical history of stroke or dementia&#xD;
&#xD;
          3. Taking anticoagulant now or having coagulation disorders&#xD;
&#xD;
          4. Scalp infection&#xD;
&#xD;
          5. Pregnant women&#xD;
&#xD;
          6. Patient with irregular heartbeat, implanted artificial cardiac pacemaker or implanted&#xD;
             cardioverter-defibrillator&#xD;
&#xD;
          7. Belonephobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fang-Pei Chen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fang-Pei Chen, MD</last_name>
    <phone>0228757454</phone>
    <email>fpchen@vghtpe.gov.tw</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03791983
org study id: 2018-10-002B
nct id: NCT03791983
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Unified Parkinson's Disease Rating Scale
time frame: 2 Months
description: 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.
measure: Micro Vibration Scan
time frame: 2 Months
description: 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.
measure: SPECT
time frame: 2 Months
description: A type of nuclear imaging test that shows how blood flows to tissues and organs.
measure: PET/MRI
time frame: 2 Months
description: 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.
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
time frame: 2 Months
description: 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.
measure: Sphygmograph
time frame: 2 Months
description: Diagnoses patient's pulse change
arm group label: Therapy Group
arm group type: Experimental
arm group label: Control Group
arm group type: Other
intervention type: Other
intervention name: Scalp Acupuncture
description: 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).
arm group label: Therapy Group
intervention type: Other
intervention name: Body Acupenture
description: 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).
arm group label: Control Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Fang-Pei Chen, MD
role: Study Chair
affiliation: Taipei Veterans General Hospital, Taiwan
last name: Fang-Pei Chen, MD
phone: 0228757454
email: fpchen@vghtpe.gov.tw
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided