<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/NCT04429048</url>
  </required_header>
  <id_info>
    <org_study_id>202002094RIND</org_study_id>
    <nct_id>NCT04429048</nct_id>
  </id_info>
  <brief_title>Effect of Acupressure in Migraine: Single-blinded, Randomized, Controlled Clinical Trial</brief_title>
  <official_title>Effect of Acupressure at PC6 on Headache in Patients With Migraine: Single-blinded, Randomized, Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Medical University, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background :&#xD;
&#xD;
      Migraine is one of the most complex, prevalent, debilitating neurologic disorder in the&#xD;
      world. In clinical experience, there are limitation over western medicine for migraine,&#xD;
      especially some extra adverse effects. In traditional Chinese medicine(TCM), there are some&#xD;
      reviews and clinical practice point out acupressure at PC6 could relieve nausea/ vomiting and&#xD;
      pain while migraine. Recent researches also mention Calcitonin gene-related peptide (CGRP)&#xD;
      and Neurokinin A (NKA) in some degree correlated with the mechanism of migraine.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      CGRP and NKA play vital roles of migraine. In comparison with oral medication only and PC6&#xD;
      acupressure via oral medication, if there were better effect for migraine control. In&#xD;
      addition, investigators evaluate the plasma CGRP and NKA level before and after study to&#xD;
      figure out if any positive value and any correlation with acupressure.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      By single-blinded, randomized, controlled clinical trial, total of 56 patients with migraine&#xD;
      were divided equally into acupressure group (modern routing standard therapy plus PC6&#xD;
      acupressure) and control group (modern routing standard therapy). Before intervention, the&#xD;
      participants needed to finish the Migraine Disability Assessment (MIDAS) questionnaire&#xD;
      evaluation. After 6 weeks, investigators will evaluate the severity, frequencies of headaches&#xD;
      and pain-killer consumption as primary outcome. In addition, investigators will investigate&#xD;
      if there were change of serum CGRP/NKA level after 6 weeks and the score changes of MOS&#xD;
      36-Item Short-Form Health Survey as secondary outcome.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      The investigators predict that PC6 acupressure may not only reduce severity, frequencies and&#xD;
      duration of headaches but also reduce the dose of NSAIDs. In addition, the PC6 acupressure&#xD;
      also may reduce levels of serum CGRP and NKA, and improve the quality of life meanwhile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Migraine is one of the most complex, prevalent, debilitating neurologic disorder and the&#xD;
      prevalence higher in female group. In general, there are many kinds of therapy for migraine&#xD;
      nowadays including of acute abortion oral drugs such as triptan, ergotamine, non-steroid&#xD;
      anti-inflammatory drugs, acetaminophen and preventive agents such as calcium channel blocker&#xD;
      (Flunarizine), anti-epileptic drugs (valproic acid, Topiramate, Pregabalin), beta&#xD;
      adrenergic-blocker (Propranolol), Selective Serotonin Reuptake Inhibitors(SSRI), anti-emetic&#xD;
      agents (Prochlorperazine) and other injection therapy such as Onabotulinum Toxin A or CGRP&#xD;
      (Calcitonin gene-related peptide) antagonist etc. The CGRP plays an important role of&#xD;
      trigemino-vascular responses in migraine. The serum CGRP levels elevated while migraine&#xD;
      attack and chronic migraine, therefore, CGRP is a potential biomarker. In recent studies,&#xD;
      higher plasma CGRP level during interictal phase of migraine or chronic migraine is indicated&#xD;
      the better response for Onabotulinum Toxin A and reduced plasma CGRP level can relieve the&#xD;
      discomfort of migraine. Neurokinin A (NKA) levels of venous blood are significantly higher in&#xD;
      responders than these nonresponse before the rizatriptan treatment, whereas reduced the&#xD;
      levels of both CGRP and NKA one hours after the treatment . The headache is associated with&#xD;
      nausea in about 80% of episodes, vomiting in about 30% in patients with migraine.&#xD;
&#xD;
      PC6 is belong to pericardium meridian locates the anterior aspect of forearm between the&#xD;
      tendons of the palmaris longus and the flexor carpi radialis, 2 cun proximal to the wrist&#xD;
      transverse stripes just on the median nerve . The antiemetic is lower for preventing&#xD;
      postoperative nausea and vomiting in the combination PC6 acupoint stimulation than these&#xD;
      patients with antiemetic only. Acupuncture at the PC6 is an effective alternative treatment&#xD;
      to conventional pharmacological treatment and resulted in almost immediate cessation of&#xD;
      intraoperative nausea and vomiting. Therefore, acupressure at PC6 is an effective and safety&#xD;
      method for nausea and vomiting. In addition, stimulation at PC6 can activate hypothalamic&#xD;
      orexin neurons, and that release orexins to induce analgesia. Taken together, PC6 stimulation&#xD;
      can produce effect of both analgesia and antiemetic effects. The present study suppose&#xD;
      stimulation at PC6 is beneficial for the treatment of migraine.&#xD;
&#xD;
      Therefore, the investigators designed a single-blinded, randomized, controlled trial to&#xD;
      evaluate the effect of acupressure at PC6 on headache in patients with migraine.&#xD;
&#xD;
      Method and study design:&#xD;
&#xD;
      (A) Participants The patients with migraine were enrolled from the outdoor patients (OPD) of&#xD;
      neurological department, Yunlin branch of National Taiwan University hospital. The basic&#xD;
      laboratory data including peripheral blood cells, Na/K/Ca/Mg, alanine aminotransferase (ALT),&#xD;
      creatinine, iron/total iron-binding capacity (TIBC)/ferritin to exclude extremely abnormal&#xD;
      metabolic disturbance or liver/renal functional impairment which may cause secondary&#xD;
      headache; and the awake electroencephalography (EEG) and brain image including computer&#xD;
      tomography (C-T) or magnetic resonance image (MRI) also were done to rule out any&#xD;
      intracranial structure lesion prior to the trial.&#xD;
&#xD;
      The migraine was diagnosed according to clinical manifestation and criteria from beta version&#xD;
      of the third edition of the International Classification of Headache Disorders (ICHD-3). In&#xD;
      addition, non-steroid anti-inflammatory drugs (NSAIDs) are used as episodic way while&#xD;
      migraine attack and Propranolol (Inderal R) is used as preventive way no matter when migraine&#xD;
      attack. In addition, the participants needed to finish the Migraine Disability Assessment&#xD;
      (MIDAS) questionnaire evaluation of 6 weeks.&#xD;
&#xD;
      (B) Study design: Single-blinded, randomized, controlled clinical trial. (C) Assessment time:&#xD;
      before PC6 acupressure (V1), two weeks after acupressure (V2), four weeks after acupressure&#xD;
      (V3) and six weeks after acupressure (D) Statistical analysis : Categorical data will be&#xD;
      displayed in numbers and percentages, whereas continuous variables will be given as means ±&#xD;
      standard deviations or median (Q1, Q3). Differences in categorical variables will be tested&#xD;
      using the chi-square test or Fisher exact test and differences in continuous variables will&#xD;
      be tested using the two sample independent t test or Mann-Whitney test between groups. The&#xD;
      generalized estimating equations (GEE) will be used to compare the change of primary outcomes&#xD;
      over time (the four time points (V1-V4)) between two groups. A p value of less than 0.05 will&#xD;
      be considered statistically significant. All statistical analyses will be performed using&#xD;
      SPSS Statistics 24or R version 3.4.4 .&#xD;
&#xD;
      Outcome :&#xD;
&#xD;
      The study of the present study predicts that PC6 acupressure may reduce severity of&#xD;
      headaches, the frequency of headache attacks and duration of headache, and also reduce the&#xD;
      dose of NSAID. In addition, the PC6 acupressure also may reduce levels of serum CGRP and NKA,&#xD;
      and also may improve the quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2020</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 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>
    <masking_description>single blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Headache duration</measure>
    <time_frame>After 6 weeks , evaluate how many episodes of lesser duration(&lt;4hours) of the two groups</time_frame>
    <description>duration (if attack less than 4hours which means better response)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache severity</measure>
    <time_frame>After 6 weeks, evaluate the headache severity (VAS score) if any decreased</time_frame>
    <description>Severity by visual analog scale (0~10), if VAS score decreased 2 points which means better results</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache frequency</measure>
    <time_frame>evaluate total headache episodes after 6 weeks</time_frame>
    <description>how many times headache occurred (if attack &lt; 8 times which means effective)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>dosage of pain killers</measure>
    <time_frame>evaluation total amount of pain-killer consumption after 6 weeks</time_frame>
    <description>how many dosage of pain kill taken (if pain killer taken less than 20 pills which means effective therapy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calcitonin gene-related peptide (CGRP) level</measure>
    <time_frame>1st time: 1 day of sign informed consent ; 2nd time: through study completion, an average of 6 weeks</time_frame>
    <description>Check serum CGRP level to evaluate the correlation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurokinin A (NKA) level</measure>
    <time_frame>1st time: 1 day of sign informed consent ; 2nd time: through study completion, an average of 6 weeks</time_frame>
    <description>Check NKA level to realize any discrepancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score of 36-Item Short Form Health Survey (SF-36)</measure>
    <time_frame>through study completion, an average of 6 weeks</time_frame>
    <description>Complete form for quality evaluation (score: 0~100, worse to better)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Migraine; Status</condition>
  <arm_group>
    <arm_group_label>acupressure group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants received modern routing standard therapy accompanied with the round plastic studs of sea-band were placed just on the skin surface of bilateral PC6 acupoints , and then keep the persistent compressive state for 3 minutes per time and three times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The participants received modern routing standard therapy only with general elastic band without bud over PC6 acupoints.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupressure elastic band (Sea-Band)</intervention_name>
    <description>The PC6 acupressure was done via Sea-Band in persistent compressive state for 3 minutes per time and three times a day , then at least 5 days in one week for 6 weeks continuously except modern routine standard therapy</description>
    <arm_group_label>acupressure group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>General elastic band (no bud)</intervention_name>
    <description>general elastic band was put over bilateral PC6 acupoints</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        A. Inclusion criteria&#xD;
&#xD;
          1. Age ranged from 20 to 50-year-old (inclusion)&#xD;
&#xD;
          2. Female or male.&#xD;
&#xD;
          3. Neurological examination was within normal limit.&#xD;
&#xD;
          4. Neither epileptiform discharge from EEG nor abnormality of neuroimage&#xD;
&#xD;
        B. Exclusion criteria&#xD;
&#xD;
          1. Headache was results from adverse effects for NSAIDs and Propranolol.&#xD;
&#xD;
          2. Active skin lesion or oozing wound over PC6 acupoints.&#xD;
&#xD;
          3. Pregnancy or lactation.&#xD;
&#xD;
          4. Recent traumatic brain injury or brain tumor.&#xD;
&#xD;
          5. Secondary headache&#xD;
&#xD;
          6. Brain surgical history.&#xD;
&#xD;
          7. Refuse sign informed consent.&#xD;
&#xD;
          8. Extremely abnormal metabolic disturbance (such as iron deficiency anemia,&#xD;
             hypo/hypernatremia, hypo/hyperkalemia, hypo/hypercalcemia, hypo/ hypermagnesemia) and&#xD;
             liver/renal dysfunction ALT &gt; 3x normal upper limits; creatinine &gt;1.4)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chih-hung Tsai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital Yunlin Branch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital Yunlin Branch</name>
      <address>
        <city>Douliu</city>
        <state>Yunlin County</state>
        <zip>64041</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 11, 2022</last_update_submitted>
  <last_update_submitted_qc>July 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine ,acupressure,CGRP,neurokinin A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04429048
org study id: 202002094RIND
nct id: NCT04429048
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background :

      Migraine is one of the most complex, prevalent, debilitating neurologic disorder in the
      world. In clinical experience, there are limitation over western medicine for migraine,
      especially some extra adverse effects. In traditional Chinese medicine(TCM), there are some
      reviews and clinical practice point out acupressure at PC6 could relieve nausea/ vomiting and
      pain while migraine. Recent researches also mention Calcitonin gene-related peptide (CGRP)
      and Neurokinin A (NKA) in some degree correlated with the mechanism of migraine.

      Objective:

      CGRP and NKA play vital roles of migraine. In comparison with oral medication only and PC6
      acupressure via oral medication, if there were better effect for migraine control. In
      addition, investigators evaluate the plasma CGRP and NKA level before and after study to
      figure out if any positive value and any correlation with acupressure.

      Method:

      By single-blinded, randomized, controlled clinical trial, total of 56 patients with migraine
      were divided equally into acupressure group (modern routing standard therapy plus PC6
      acupressure) and control group (modern routing standard therapy). Before intervention, the
      participants needed to finish the Migraine Disability Assessment (MIDAS) questionnaire
      evaluation. After 6 weeks, investigators will evaluate the severity, frequencies of headaches
      and pain-killer consumption as primary outcome. In addition, investigators will investigate
      if there were change of serum CGRP/NKA level after 6 weeks and the score changes of MOS
      36-Item Short-Form Health Survey as secondary outcome.

      Expected results:

      The investigators predict that PC6 acupressure may not only reduce severity, frequencies and
      duration of headaches but also reduce the dose of NSAIDs. In addition, the PC6 acupressure
      also may reduce levels of serum CGRP and NKA, and improve the quality of life meanwhile.
Introduction:

      Migraine is one of the most complex, prevalent, debilitating neurologic disorder and the
      prevalence higher in female group. In general, there are many kinds of therapy for migraine
      nowadays including of acute abortion oral drugs such as triptan, ergotamine, non-steroid
      anti-inflammatory drugs, acetaminophen and preventive agents such as calcium channel blocker
      (Flunarizine), anti-epileptic drugs (valproic acid, Topiramate, Pregabalin), beta
      adrenergic-blocker (Propranolol), Selective Serotonin Reuptake Inhibitors(SSRI), anti-emetic
      agents (Prochlorperazine) and other injection therapy such as Onabotulinum Toxin A or CGRP
      (Calcitonin gene-related peptide) antagonist etc. The CGRP plays an important role of
      trigemino-vascular responses in migraine. The serum CGRP levels elevated while migraine
      attack and chronic migraine, therefore, CGRP is a potential biomarker. In recent studies,
      higher plasma CGRP level during interictal phase of migraine or chronic migraine is indicated
      the better response for Onabotulinum Toxin A and reduced plasma CGRP level can relieve the
      discomfort of migraine. Neurokinin A (NKA) levels of venous blood are significantly higher in
      responders than these nonresponse before the rizatriptan treatment, whereas reduced the
      levels of both CGRP and NKA one hours after the treatment . The headache is associated with
      nausea in about 80% of episodes, vomiting in about 30% in patients with migraine.

      PC6 is belong to pericardium meridian locates the anterior aspect of forearm between the
      tendons of the palmaris longus and the flexor carpi radialis, 2 cun proximal to the wrist
      transverse stripes just on the median nerve . The antiemetic is lower for preventing
      postoperative nausea and vomiting in the combination PC6 acupoint stimulation than these
      patients with antiemetic only. Acupuncture at the PC6 is an effective alternative treatment
      to conventional pharmacological treatment and resulted in almost immediate cessation of
      intraoperative nausea and vomiting. Therefore, acupressure at PC6 is an effective and safety
      method for nausea and vomiting. In addition, stimulation at PC6 can activate hypothalamic
      orexin neurons, and that release orexins to induce analgesia. Taken together, PC6 stimulation
      can produce effect of both analgesia and antiemetic effects. The present study suppose
      stimulation at PC6 is beneficial for the treatment of migraine.

      Therefore, the investigators designed a single-blinded, randomized, controlled trial to
      evaluate the effect of acupressure at PC6 on headache in patients with migraine.

      Method and study design:

      (A) Participants The patients with migraine were enrolled from the outdoor patients (OPD) of
      neurological department, Yunlin branch of National Taiwan University hospital. The basic
      laboratory data including peripheral blood cells, Na/K/Ca/Mg, alanine aminotransferase (ALT),
      creatinine, iron/total iron-binding capacity (TIBC)/ferritin to exclude extremely abnormal
      metabolic disturbance or liver/renal functional impairment which may cause secondary
      headache; and the awake electroencephalography (EEG) and brain image including computer
      tomography (C-T) or magnetic resonance image (MRI) also were done to rule out any
      intracranial structure lesion prior to the trial.

      The migraine was diagnosed according to clinical manifestation and criteria from beta version
      of the third edition of the International Classification of Headache Disorders (ICHD-3). In
      addition, non-steroid anti-inflammatory drugs (NSAIDs) are used as episodic way while
      migraine attack and Propranolol (Inderal R) is used as preventive way no matter when migraine
      attack. In addition, the participants needed to finish the Migraine Disability Assessment
      (MIDAS) questionnaire evaluation of 6 weeks.

      (B) Study design: Single-blinded, randomized, controlled clinical trial. (C) Assessment time:
      before PC6 acupressure (V1), two weeks after acupressure (V2), four weeks after acupressure
      (V3) and six weeks after acupressure (D) Statistical analysis : Categorical data will be
      displayed in numbers and percentages, whereas continuous variables will be given as means ±
      standard deviations or median (Q1, Q3). Differences in categorical variables will be tested
      using the chi-square test or Fisher exact test and differences in continuous variables will
      be tested using the two sample independent t test or Mann-Whitney test between groups. The
      generalized estimating equations (GEE) will be used to compare the change of primary outcomes
      over time (the four time points (V1-V4)) between two groups. A p value of less than 0.05 will
      be considered statistically significant. All statistical analyses will be performed using
      SPSS Statistics 24or R version 3.4.4 .

      Outcome :

      The study of the present study predicts that PC6 acupressure may reduce severity of
      headaches, the frequency of headache attacks and duration of headache, and also reduce the
      dose of NSAID. In addition, the PC6 acupressure also may reduce levels of serum CGRP and NKA,
      and also may improve the quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: single blind
measure: Headache duration
time frame: After 6 weeks , evaluate how many episodes of lesser duration(<4hours) of the two groups
description: duration (if attack less than 4hours which means better response)
measure: Headache severity
time frame: After 6 weeks, evaluate the headache severity (VAS score) if any decreased
description: Severity by visual analog scale (0~10), if VAS score decreased 2 points which means better results
measure: Headache frequency
time frame: evaluate total headache episodes after 6 weeks
description: how many times headache occurred (if attack < 8 times which means effective)
measure: dosage of pain killers
time frame: evaluation total amount of pain-killer consumption after 6 weeks
description: how many dosage of pain kill taken (if pain killer taken less than 20 pills which means effective therapy)
measure: Calcitonin gene-related peptide (CGRP) level
time frame: 1st time: 1 day of sign informed consent ; 2nd time: through study completion, an average of 6 weeks
description: Check serum CGRP level to evaluate the correlation
measure: Neurokinin A (NKA) level
time frame: 1st time: 1 day of sign informed consent ; 2nd time: through study completion, an average of 6 weeks
description: Check NKA level to realize any discrepancy
measure: the score of 36-Item Short Form Health Survey (SF-36)
time frame: through study completion, an average of 6 weeks
description: Complete form for quality evaluation (score: 0~100, worse to better)
arm group label: acupressure group
arm group type: Experimental
description: The participants received modern routing standard therapy accompanied with the round plastic studs of sea-band were placed just on the skin surface of bilateral PC6 acupoints , and then keep the persistent compressive state for 3 minutes per time and three times a day.
arm group label: control group
arm group type: Sham Comparator
description: The participants received modern routing standard therapy only with general elastic band without bud over PC6 acupoints.
intervention type: Device
intervention name: Acupressure elastic band (Sea-Band)
description: The PC6 acupressure was done via Sea-Band in persistent compressive state for 3 minutes per time and three times a day , then at least 5 days in one week for 6 weeks continuously except modern routine standard therapy
arm group label: acupressure group
intervention type: Device
intervention name: General elastic band (no bud)
description: general elastic band was put over bilateral PC6 acupoints
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Chih-hung Tsai, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital Yunlin Branch
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Migraine Disorders