<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/NCT03263897</url>
  </required_header>
  <id_info>
    <org_study_id>CI-IRB-20170814001</org_study_id>
    <nct_id>NCT03263897</nct_id>
  </id_info>
  <brief_title>Feasibility of Using a Mobile Device Controlled Micro-pressure Pulse Insufflator for Acute Migraine Relief</brief_title>
  <official_title>Feasibility of Using a Mobile Device Controlled Micro-pressure Pulse Insufflator for Acute Migraine Relief</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Caps Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Caps Research Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the feasibility of using a mobile interface to control the insufflator device&#xD;
      administering treatment for aborting (stopping) an acute episode of migraine. The patient,&#xD;
      under clinical supervision, will use the mobile interface to &quot;self administer&quot; the treatment&#xD;
      when experiencing an acute episode of migraine. The supervising clinician will monitor the&#xD;
      patient and the device to make sure that no harm could come to the patient and will be ready&#xD;
      to intervene if any adverse effects were suspected to or in the process of happening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing the consent form and being enrolled in the study, the subject will be asked to&#xD;
      answer an enrollment questionnaire on the general characteristics of the migraine attacks he&#xD;
      or she is suffering. Then, the subject will be instructed to call 1-800 number to notify the&#xD;
      clinic that they have a migraine.&#xD;
&#xD;
      Upon presentation with an acute migraine attack, the patient will be randomly assigned to two&#xD;
      groups: an active comparator and a sham comparator. During the first session, the active&#xD;
      group will receive the actual treatment whereas the placebo group will receive a sham&#xD;
      treatment (using an exact replica of the device with the same software and hardware controls&#xD;
      that delivers a simulated treatment with no actual pressure delivered - only a simulation of&#xD;
      mechanical functions and sounds to simulate an actual treatment). During the second&#xD;
      treatment, both groups will receive the actual treatment.&#xD;
&#xD;
      During either session, upon presentation with an acute migraine attack, the subject will be&#xD;
      assessed by taking blood pressure, pulse, temperature, subjective pain score on a scale of&#xD;
      0-10 (similar to the scales used in the device's interface) and on a scale from 0 to 3&#xD;
      (typically used in headache studies to establish the pain level) as well as subjective&#xD;
      associated symptoms scores on the same 0-10 scale. Bilateral otoscopic examination will be&#xD;
      used to confirm intact tympanic membranes to ensure that subjects can safely receive the&#xD;
      treatment. Also, subjects will receive bilateral hearing screening and their ability to&#xD;
      maintain balance will be assessed. Then the subjects will be attached to a comfortable heart&#xD;
      rate variability (HRV) monitor and asked to lie down quietly for 5 min so as to obtain a&#xD;
      baseline HRV recording. Soft silicone ear plugs will be inserted in the subject's ears. These&#xD;
      plugs are attached to the automated insufflator device (active or sham, depending on the&#xD;
      group the subject is assigned to). The subject will control the device using a mobile app: an&#xD;
      easy to use interface will allow the subject to provide the device all the information needed&#xD;
      for the automatic selection of the treatment protocol most appropriate for the subject. Once&#xD;
      selected, the treatment will last 30 minutes. The subjects heart rate, HRV, and pulse&#xD;
      oxygenation will be monitored throughout the insufflation procedure to measure physiologic&#xD;
      response to the procedure as well as to bolster the safety of the procedure. The heart rate&#xD;
      and pulse Ox values will be recorded every minute (heart rate and pulse ox) on the vitals&#xD;
      form, the HRV will be a continuous recording for the entire duration of the treatment. After&#xD;
      10 and 20min of treatment, the subject will be asked the corresponding pain score on a scale&#xD;
      of 0-10. Vitals will be taken again at the end of the treatment. The subject will then be&#xD;
      asked to lie again quietly for 5 mins as a final HRV recording is obtained for comparison&#xD;
      against the pre-evaluation one. Bilateral hearing and ability to maintain balance will also&#xD;
      be screened again at the end of the treatment and compared with the pre-treatment measures to&#xD;
      see if they were affected by the treatment.&#xD;
&#xD;
      Subjective pain and symptom scores will be obtained immediately after the 30min treatment,&#xD;
      and at the 2 hour post and 24 hour post treatment end points. Each user will receive only a&#xD;
      single treatment, administered in the clinic setting. 2 hour and 24 hour end point&#xD;
      assessments will be obtained telephonically.&#xD;
&#xD;
      The second visit will follow the identical procedure with the exception that all subjects&#xD;
      will receive an actual treatment at this stage.&#xD;
&#xD;
      Independently whether they come back for the second visit, subjects will be questioned by&#xD;
      telephone one calendar month after their first treatment as to the number, type and intensity&#xD;
      of migraines experienced in the period between the first treatment and the 1-month follow up&#xD;
      phone call.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Manufacturer's decision&#xD;
  </why_stopped>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Changes in Symptoms severity scale</measure>
    <time_frame>Baseline, immediately post-treatment</time_frame>
    <description>Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and immediately post treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in pain level</measure>
    <time_frame>Baseline, immediately post-treatment</time_frame>
    <description>Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and immediately post treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Symptoms severity scale at 2 hours</measure>
    <time_frame>Baseline, 2 hours post-treatment</time_frame>
    <description>Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 2h post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Symptoms severity scale at 24 hours</measure>
    <time_frame>Baseline, 24 hours post-treatment</time_frame>
    <description>Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 24h post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain level at 2 hours</measure>
    <time_frame>Baseline, 2 hours post-treatment</time_frame>
    <description>Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and 2h post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain level at 24 hours</measure>
    <time_frame>Baseline, 24 hours post-treatment</time_frame>
    <description>Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and 24h post treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving insufflation during an acute episode of migraine in both visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Receiving placebo insufflation during an acute episode of migraine in the first visit and receiving insufflation during an acute episode in the second visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>insufflation</intervention_name>
    <description>mobile interface driven insufflation of the ear canal</description>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>placebo insufflation</intervention_name>
    <description>mobile interface driven placebo insufflation of the ear canal</description>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult subjects suffering from acute migraine episodes&#xD;
&#xD;
          -  Possibly located in the Phoenix, AZ area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant/nursing women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M George, DC</last_name>
    <role>Principal Investigator</role>
    <affiliation>GBS Ventures</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>YRMC: Physiatry, Neurosurgery, Neurology Clinic</name>
      <address>
        <city>Prescott</city>
        <state>Arizona</state>
        <zip>86301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FNOR Clinic Scottsdale</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>D.M. George, G. Pagnacco, K.E. Willey, J.P. Claude, E. Oggero &quot;SAFETY AND USABILITY FACTORS IN DEVELOPMENT OF A NOVEL, AUTOMATED TREATMENT DEVICE FOR ACUTE MIGRAINE&quot;, Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 398-403.</citation>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abortive effect</keyword>
  <keyword>mobile interface</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03263897
org study id: CI-IRB-20170814001
nct id: NCT03263897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Evaluate the feasibility of using a mobile interface to control the insufflator device
      administering treatment for aborting (stopping) an acute episode of migraine. The patient,
      under clinical supervision, will use the mobile interface to "self administer" the treatment
      when experiencing an acute episode of migraine. The supervising clinician will monitor the
      patient and the device to make sure that no harm could come to the patient and will be ready
      to intervene if any adverse effects were suspected to or in the process of happening.
After signing the consent form and being enrolled in the study, the subject will be asked to
      answer an enrollment questionnaire on the general characteristics of the migraine attacks he
      or she is suffering. Then, the subject will be instructed to call 1-800 number to notify the
      clinic that they have a migraine.

      Upon presentation with an acute migraine attack, the patient will be randomly assigned to two
      groups: an active comparator and a sham comparator. During the first session, the active
      group will receive the actual treatment whereas the placebo group will receive a sham
      treatment (using an exact replica of the device with the same software and hardware controls
      that delivers a simulated treatment with no actual pressure delivered - only a simulation of
      mechanical functions and sounds to simulate an actual treatment). During the second
      treatment, both groups will receive the actual treatment.

      During either session, upon presentation with an acute migraine attack, the subject will be
      assessed by taking blood pressure, pulse, temperature, subjective pain score on a scale of
      0-10 (similar to the scales used in the device's interface) and on a scale from 0 to 3
      (typically used in headache studies to establish the pain level) as well as subjective
      associated symptoms scores on the same 0-10 scale. Bilateral otoscopic examination will be
      used to confirm intact tympanic membranes to ensure that subjects can safely receive the
      treatment. Also, subjects will receive bilateral hearing screening and their ability to
      maintain balance will be assessed. Then the subjects will be attached to a comfortable heart
      rate variability (HRV) monitor and asked to lie down quietly for 5 min so as to obtain a
      baseline HRV recording. Soft silicone ear plugs will be inserted in the subject's ears. These
      plugs are attached to the automated insufflator device (active or sham, depending on the
      group the subject is assigned to). The subject will control the device using a mobile app: an
      easy to use interface will allow the subject to provide the device all the information needed
      for the automatic selection of the treatment protocol most appropriate for the subject. Once
      selected, the treatment will last 30 minutes. The subjects heart rate, HRV, and pulse
      oxygenation will be monitored throughout the insufflation procedure to measure physiologic
      response to the procedure as well as to bolster the safety of the procedure. The heart rate
      and pulse Ox values will be recorded every minute (heart rate and pulse ox) on the vitals
      form, the HRV will be a continuous recording for the entire duration of the treatment. After
      10 and 20min of treatment, the subject will be asked the corresponding pain score on a scale
      of 0-10. Vitals will be taken again at the end of the treatment. The subject will then be
      asked to lie again quietly for 5 mins as a final HRV recording is obtained for comparison
      against the pre-evaluation one. Bilateral hearing and ability to maintain balance will also
      be screened again at the end of the treatment and compared with the pre-treatment measures to
      see if they were affected by the treatment.

      Subjective pain and symptom scores will be obtained immediately after the 30min treatment,
      and at the 2 hour post and 24 hour post treatment end points. Each user will receive only a
      single treatment, administered in the clinic setting. 2 hour and 24 hour end point
      assessments will be obtained telephonically.

      The second visit will follow the identical procedure with the exception that all subjects
      will receive an actual treatment at this stage.

      Independently whether they come back for the second visit, subjects will be questioned by
      telephone one calendar month after their first treatment as to the number, type and intensity
      of migraines experienced in the period between the first treatment and the 1-month follow up
      phone call.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in Symptoms severity scale
time frame: Baseline, immediately post-treatment
description: Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and immediately post treatment
measure: Changes in pain level
time frame: Baseline, immediately post-treatment
description: Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and immediately post treatment
measure: Changes in Symptoms severity scale at 2 hours
time frame: Baseline, 2 hours post-treatment
description: Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 2h post treatment
measure: Changes in Symptoms severity scale at 24 hours
time frame: Baseline, 24 hours post-treatment
description: Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 24h post treatment
measure: Changes in pain level at 2 hours
time frame: Baseline, 2 hours post-treatment
description: Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and 2h post treatment
measure: Changes in pain level at 24 hours
time frame: Baseline, 24 hours post-treatment
description: Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and 24h post treatment
arm group label: Active
arm group type: Experimental
description: Receiving insufflation during an acute episode of migraine in both visits
arm group label: Sham
arm group type: Sham Comparator
description: Receiving placebo insufflation during an acute episode of migraine in the first visit and receiving insufflation during an acute episode in the second visit
intervention type: Device
intervention name: insufflation
description: mobile interface driven insufflation of the ear canal
arm group label: Active
arm group label: Sham
intervention type: Device
intervention name: placebo insufflation
description: mobile interface driven placebo insufflation of the ear canal
arm group label: Sham
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: David M George, DC
role: Principal Investigator
affiliation: GBS Ventures
facility: 
facility: 
country: United States
citation: D.M. George, G. Pagnacco, K.E. Willey, J.P. Claude, E. Oggero "SAFETY AND USABILITY FACTORS IN DEVELOPMENT OF A NOVEL, AUTOMATED TREATMENT DEVICE FOR ACUTE MIGRAINE", Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 398-403.
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: No