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/NCT05981755</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-20-1228</org_study_id>
      <secondary_id>R01NS133743</secondary_id>
      <nct_id>NCT05981755</nct_id>
    </id_info>
    <brief_title>Breathing Rescue for SUDEP Prevention</brief_title>
    <acronym>BreatheS</acronym>
    <official_title>Breathing Rescue for SUDEP Prevention (BreatheS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to precisely delineate human brain networks that modulate&#xD;
        respiration and identify specific brain areas and stimulation techniques that can be used to&#xD;
        prevent seizure-induced breathing failure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal</measure>
      <time_frame>baseline (before breathing task), at the time of the breathing task (about 8 minutes after start of baseline)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in presence of breathing nodes as assessed by EEG signal</measure>
      <time_frame>Baseline (before breathing task), at the time of the breathing task(about 8 minutes after start of baseline)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,</measure>
      <time_frame>Baseline, during the stimulation session (at least 2 hours after baseline)</time_frame>
      <description>Lower and higher frequencies up to 50 Hertz(Hz), current of 1-10 milli ampere (mA), pulse durations of 0.2 milli second (msec) and stimulation periods of 10 to 40 seconds will be used.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]</measure>
      <time_frame>Baseline, during the stimulation session (at least 2 hours after baseline)</time_frame>
      <description>Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry</measure>
      <time_frame>Baseline, during the stimulation session (at least 2 hours after baseline)</time_frame>
      <description>Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in end tidal carbon dioxide (CO2) during stimulation</measure>
      <time_frame>Baseline, during the stimulation session (at least 2 hours after baseline)</time_frame>
      <description>Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quantification of the breathing changes as assessed by the change in breathing rate</measure>
      <time_frame>baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)</time_frame>
      <description>Breathing rate is the number of breaths taken per minute. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of the breathing changes as assessed by the change in breathing depth</measure>
      <time_frame>baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)</time_frame>
      <description>Breathing depth, or tidal volume (TV), is the amount of air that normally enters the lungs during quiet breathing. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)</measure>
      <time_frame>baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)</time_frame>
      <description>Minute ventilation, also known as total ventilation, is a measurement of the amount of air that enters the lungs per minute. It is the product of respiratory rate and tidal volume. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Focal Epilepsy</condition>
    <arm_group>
      <arm_group_label>Breathing tasks and Brain mapping with stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breathing tasks</intervention_name>
      <description>Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.</description>
      <arm_group_label>Breathing tasks and Brain mapping with stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Brain mapping with stimulation</intervention_name>
      <description>Electrical stimulation will be used to find specific areas of the brain involved in breathing function. Stimulation will be applied using a Nihon Kohden MEE-1000A neural function measuring system with the MS-120BK extension unit for brain stimulation.</description>
      <arm_group_label>Breathing tasks and Brain mapping with stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of intractable focal epilepsy&#xD;
  &#xD;
            -  admitted to the Epilepsy Monitoring Unit (EMU) at Memorial Hermann-Texas Medical&#xD;
               Center for intracranial subdural strips, grids, or depth electrode placement study&#xD;
               (invasive video-EEG)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  respiratory, cardiac or cerebrovascular disease&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  prisoners&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nuria L Lecumberri, MD,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nuria L Lecumberri, MD,PhD</last_name>
      <phone>713-500-7785</phone>
      <email>Nuria.Lacuey@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jaison Hampson</last_name>
      <phone>713-500-7754</phone>
      <email>Jaison.S.Hampson@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nuria L Lecumberri, MD,PhD</last_name>
        <phone>713-500-7785</phone>
        <email>Nuria.Lacuey@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jaison Hampson</last_name>
        <phone>713-500-7754</phone>
        <email>Jaison.S.Hampson@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Nuria Lacuey Lecumberri</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epilepsies, Partial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05981755
  org study id: HSC-MS-20-1228
  secondary id: R01NS133743
  nct id: NCT05981755
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to precisely delineate human brain networks that modulate
        respiration and identify specific brain areas and stimulation techniques that can be used to
        prevent seizure-induced breathing failure.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
  time frame: baseline (before breathing task), at the time of the breathing task (about 8 minutes after start of baseline)
  measure: Change in presence of breathing nodes as assessed by EEG signal
  time frame: Baseline (before breathing task), at the time of the breathing task(about 8 minutes after start of baseline)
  measure: Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,
  time frame: Baseline, during the stimulation session (at least 2 hours after baseline)
  description: Lower and higher frequencies up to 50 Hertz(Hz), current of 1-10 milli ampere (mA), pulse durations of 0.2 milli second (msec) and stimulation periods of 10 to 40 seconds will be used.
  measure: Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]
  time frame: Baseline, during the stimulation session (at least 2 hours after baseline)
  description: Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.
  measure: Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry
  time frame: Baseline, during the stimulation session (at least 2 hours after baseline)
  description: Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.
  measure: Change in end tidal carbon dioxide (CO2) during stimulation
  time frame: Baseline, during the stimulation session (at least 2 hours after baseline)
  description: Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.
  measure: Quantification of the breathing changes as assessed by the change in breathing rate
  time frame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
  description: Breathing rate is the number of breaths taken per minute. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).
  measure: Quantification of the breathing changes as assessed by the change in breathing depth
  time frame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
  description: Breathing depth, or tidal volume (TV), is the amount of air that normally enters the lungs during quiet breathing. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).
  measure: Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)
  time frame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
  description: Minute ventilation, also known as total ventilation, is a measurement of the amount of air that enters the lungs per minute. It is the product of respiratory rate and tidal volume. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).
  arm group label: Breathing tasks and Brain mapping with stimulation
  arm group type: Experimental
  intervention type: Other
  intervention name: Breathing tasks
  description: Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.
  arm group label: Breathing tasks and Brain mapping with stimulation
  intervention type: Device
  intervention name: Brain mapping with stimulation
  description: Electrical stimulation will be used to find specific areas of the brain involved in breathing function. Stimulation will be applied using a Nihon Kohden MEE-1000A neural function measuring system with the MS-120BK extension unit for brain stimulation.
  arm group label: Breathing tasks and Brain mapping with stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nuria L Lecumberri, MD,PhD
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Nuria L Lecumberri, MD,PhD
  phone: 713-500-7785
  email: Nuria.Lacuey@uth.tmc.edu
  last name: Jaison Hampson
  phone: 713-500-7754
  email: Jaison.S.Hampson@uth.tmc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Nuria Lacuey Lecumberri
  investigator title: Assistant Professor
  mesh term: Epilepsies, Partial
  sharing ipd: No