xml: <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/NCT06001593</url>
    </required_header>
    <id_info>
      <org_study_id>2304-098-1425</org_study_id>
      <nct_id>NCT06001593</nct_id>
    </id_info>
    <brief_title>Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation</brief_title>
    <official_title>Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</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 is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To&#xD;
        explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid&#xD;
        behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's&#xD;
        disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 7, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)</measure>
      <time_frame>0,2,4,8,12 weeks during electrical stimulation</time_frame>
      <description>Verifying therapeutic effect of electrical stimulation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)</measure>
      <time_frame>0,4,8,12 weeks during electrical stimulation</time_frame>
      <description>Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Valuation of hearing threshold with pure tone audiometry(Efficacy)</measure>
      <time_frame>0,4,8,12 weeks during electrical stimulation</time_frame>
      <description>Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>electroencephalography(Efficacy)</measure>
      <time_frame>0,1,4,8,12 weeks during electrical stimulation</time_frame>
      <description>Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Meniere's Disease</condition>
    <arm_group>
      <arm_group_label>electircal stimulation + betahistine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>sham electircal stimulation + betahistine</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>betahistine</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>YPS-201b</intervention_name>
      <description>electrical stimulation device.</description>
      <arm_group_label>electircal stimulation + betahistine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>betahistine</intervention_name>
      <description>Relieve symptoms of balance disorders or dizziness</description>
      <arm_group_label>betahistine</arm_group_label>
      <arm_group_label>electircal stimulation + betahistine</arm_group_label>
      <arm_group_label>sham electircal stimulation + betahistine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>YPS-201b</intervention_name>
      <description>sham electrical stimulation device.</description>
      <arm_group_label>sham electircal stimulation + betahistine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with dizziness (Meniere's) only, who understand the nature of the study and&#xD;
               are willing to participate voluntarily.&#xD;
  &#xD;
            -  The frequency of the hearing loss is between 250 kHz and 1 kHz.&#xD;
  &#xD;
            -  Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65 dB&#xD;
               HL&#xD;
  &#xD;
            -  Patients who have received conventional pharmacotherapy for other dizziness conditions&#xD;
               with a washout period of 2 months.&#xD;
  &#xD;
            -  To be eligible for subjects in the active phase of the disease, there must be at least&#xD;
               1 vertigo attack in the 6 months before study entry.&#xD;
  &#xD;
            -  If tests for renal function, electrolytes, etc. are performed and no problems are&#xD;
               found&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media,&#xD;
               profound hearing loss, hyperacusis, etc.).&#xD;
  &#xD;
            -  Patients' conditions that may affect EEG measurements, such as a stroke, brain&#xD;
               hemorrhage, or brain tumor.&#xD;
  &#xD;
            -  Patients with kidney disease&#xD;
  &#xD;
            -  Patients Have or have had a serious medical condition, such as cancer (including&#xD;
               leukemia, blood cancers, epilepsy, and neuropsychiatric conditions).&#xD;
  &#xD;
            -  Patients with an artificial implant in the body (cochlear implant, hip joint,&#xD;
               pacemaker, etc.)&#xD;
  &#xD;
            -  Women of childbearing potential, pregnant women, or nursing mothers&#xD;
  &#xD;
            -  Patients who can have Injuries or dermatologic abnormalities at the site of&#xD;
               application of the equipment.&#xD;
  &#xD;
            -  Patients with coronary artery disease, uncontrolled high blood pressure, or other&#xD;
               serious medical conditions (including kidney disease).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Myung-Whan Suh</last_name>
      <phone>+821039490330</phone>
      <email>drmung@naver.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dong-min Kang</last_name>
      <email>dongmin_4@naver.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Myung-Whan Suh</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Electrical stimulation</keyword>
    <keyword>Electroceutical</keyword>
    <keyword>Meniere's disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vertigo</mesh_term>
      <mesh_term>Meniere Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Betahistine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001593
  org study id: 2304-098-1425
  nct id: NCT06001593
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To
        explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid
        behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's
        disease.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
  time frame: 0,2,4,8,12 weeks during electrical stimulation
  description: Verifying therapeutic effect of electrical stimulation
  measure: Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)
  time frame: 0,4,8,12 weeks during electrical stimulation
  description: Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.
  measure: Valuation of hearing threshold with pure tone audiometry(Efficacy)
  time frame: 0,4,8,12 weeks during electrical stimulation
  description: Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
  measure: electroencephalography(Efficacy)
  time frame: 0,1,4,8,12 weeks during electrical stimulation
  description: Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.
  arm group label: electircal stimulation + betahistine
  arm group type: Experimental
  arm group label: sham electircal stimulation + betahistine
  arm group type: Sham Comparator
  arm group label: betahistine
  arm group type: Other
  description: control group
  intervention type: Device
  intervention name: YPS-201b
  description: electrical stimulation device.
  arm group label: electircal stimulation + betahistine
  intervention type: Drug
  intervention name: betahistine
  description: Relieve symptoms of balance disorders or dizziness
  arm group label: betahistine
  arm group label: electircal stimulation + betahistine
  arm group label: sham electircal stimulation + betahistine
  intervention type: Device
  intervention name: YPS-201b
  description: sham electrical stimulation device.
  arm group label: sham electircal stimulation + betahistine
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Myung-Whan Suh
  phone: +821039490330
  email: drmung@naver.com
  last name: Dong-min Kang
  email: dongmin_4@naver.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Vertigo
  mesh term: Meniere Disease
  mesh term: Betahistine