<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/NCT01685476</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0124</org_study_id>
    <secondary_id>2010-A00509-30</secondary_id>
    <nct_id>NCT01685476</nct_id>
  </id_info>
  <brief_title>NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit</brief_title>
  <acronym>MINIPIC REA</acronym>
  <official_title>Validation of a New Non Invasive Method for Intracranial Pressure Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Echodia SAS</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing&#xD;
      and treating several conditions. Physicians having to manage cases of head trauma, stroke and&#xD;
      hydrocephalus need to assess the time course of ICP, yet they are often unwilling to&#xD;
      implement invasive monitoring beyond the acute stage, on account of high septic risks.&#xD;
      Standard techniques include direct ventricular manometry or measurement in the parenchyma&#xD;
      with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods&#xD;
      for gaining access to pressure changes is an important challenge. Fluctuations of ICP are&#xD;
      transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The&#xD;
      Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the&#xD;
      intra-labyrinthic pressure modify the functional activities of the outer hair cells in the&#xD;
      cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure,&#xD;
      which is detected as modifications in cochlear activities. Cochlear activities' recording are&#xD;
      non-invasive and technically simple. A probe is gently inserted into the outer portion of the&#xD;
      external ear canal.&#xD;
&#xD;
      The objective of this study is to assess prospectively the accuracy and the precision of a&#xD;
      new method for ICP monitoring (using cochlear activities) compared with invasive gold&#xD;
      standard CSF pressure monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the evolution of the electrophysiological cochlear&#xD;
      activity (cochlear microphonic potential, CMP), with a non invasive method, during invasive&#xD;
      ICP monitoring. The data analysis will determine relationship between ICP variations and CMP&#xD;
      variations.&#xD;
&#xD;
      Continuous ICP monitoring has an important place in neuro-intensive care. ICP may be measured&#xD;
      either within the ventricular cerebrospinal fluid or within the brain parenchyma.&#xD;
&#xD;
      The purpose of this study is to assess prospectively the accuracy and the precision of a new&#xD;
      method for indirect ICP monitoring (using electrophysiological cochlear activity) compared&#xD;
      with an invasive gold standard ICP monitoring. The data analysis will determine relationship&#xD;
      between ICP variations and CMP variations.&#xD;
&#xD;
      Electrophysiological cochlear activities, so called electrocochleography (ECochG), are a non&#xD;
      invasive and totally passive method used in routine in ENT department. The response measured&#xD;
      in ECochG is the cochlear microphonic potential (CMP), generated by the outer hair cells&#xD;
      following by presenting tone burst at 1kHz. CMP is recorded with the help of an Echodia®&#xD;
      hand-held equipment.&#xD;
&#xD;
      Technically, a simple, non-invasive detection of ICP changes and ICP monitoring can be&#xD;
      afforded by CMP recordings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 4</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cochlear Microphonic Potential phase shift</measure>
    <time_frame>acquisition every 5minutes during 4hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>IntraCranialPressure variations</measure>
    <time_frame>every minutes during 4 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Intracranial Pressure</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Stroke</condition>
  <condition>Intracranial Hemorrhages</condition>
  <arm_group>
    <arm_group_label>Intracranial pressure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Echodia® hand-held equipment</intervention_name>
    <arm_group_label>Intracranial pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with intracranial pressure monitoring&#xD;
&#xD;
          -  Age greater than 18&#xD;
&#xD;
          -  consent form signed by a close relative (husband, wife, children, legal guardian),&#xD;
&#xD;
          -  Patient covered under French social security or being a beneficiary of such a regime&#xD;
             under the terms of the Act of August 9, 2004&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal by the close relative to sign a consent form&#xD;
&#xD;
          -  Impossibility of electrophysiological measurements (pathophysiological reason)&#xD;
&#xD;
          -  Technical troubles with the device&#xD;
&#xD;
          -  Patient uncovered under French social security&#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>Laurent SAKKA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cochlear microphonic potential</keyword>
  <keyword>non invasive method</keyword>
  <keyword>indirect monitoring</keyword>
  <keyword>intracranial pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Hemorrhage</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/NCT01685476
org study id: CHU-0124
secondary id: 2010-A00509-30
nct id: NCT01685476
lead sponsor: 
collaborator: 
In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing
      and treating several conditions. Physicians having to manage cases of head trauma, stroke and
      hydrocephalus need to assess the time course of ICP, yet they are often unwilling to
      implement invasive monitoring beyond the acute stage, on account of high septic risks.
      Standard techniques include direct ventricular manometry or measurement in the parenchyma
      with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods
      for gaining access to pressure changes is an important challenge. Fluctuations of ICP are
      transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The
      Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the
      intra-labyrinthic pressure modify the functional activities of the outer hair cells in the
      cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure,
      which is detected as modifications in cochlear activities. Cochlear activities' recording are
      non-invasive and technically simple. A probe is gently inserted into the outer portion of the
      external ear canal.

      The objective of this study is to assess prospectively the accuracy and the precision of a
      new method for ICP monitoring (using cochlear activities) compared with invasive gold
      standard CSF pressure monitoring.
The purpose of this study is to examine the evolution of the electrophysiological cochlear
      activity (cochlear microphonic potential, CMP), with a non invasive method, during invasive
      ICP monitoring. The data analysis will determine relationship between ICP variations and CMP
      variations.

      Continuous ICP monitoring has an important place in neuro-intensive care. ICP may be measured
      either within the ventricular cerebrospinal fluid or within the brain parenchyma.

      The purpose of this study is to assess prospectively the accuracy and the precision of a new
      method for indirect ICP monitoring (using electrophysiological cochlear activity) compared
      with an invasive gold standard ICP monitoring. The data analysis will determine relationship
      between ICP variations and CMP variations.

      Electrophysiological cochlear activities, so called electrocochleography (ECochG), are a non
      invasive and totally passive method used in routine in ENT department. The response measured
      in ECochG is the cochlear microphonic potential (CMP), generated by the outer hair cells
      following by presenting tone burst at 1kHz. CMP is recorded with the help of an Echodia®
      hand-held equipment.

      Technically, a simple, non-invasive detection of ICP changes and ICP monitoring can be
      afforded by CMP recordings.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: Cochlear Microphonic Potential phase shift
time frame: acquisition every 5minutes during 4hours
measure: IntraCranialPressure variations
time frame: every minutes during 4 hours
arm group label: Intracranial pressure
arm group type: Other
intervention type: Device
intervention name: Echodia® hand-held equipment
arm group label: Intracranial pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent SAKKA
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Intracranial Hemorrhages
mesh term: Hemorrhage