<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/NCT01685450</url>
  </required_header>
  <id_info>
    <org_study_id>CHU 0123</org_study_id>
    <secondary_id>2010-A00266-33</secondary_id>
    <nct_id>NCT01685450</nct_id>
  </id_info>
  <brief_title>NIMIP: Non Invasive Measurement of the Intracranial Pressure</brief_title>
  <acronym>MINIPIC</acronym>
  <official_title>Validation of a New Non Invasive Method of Indirect Measurement of the Intracranial Pressure Variations</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>
      The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal&#xD;
      fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases.&#xD;
      Continuous ICP monitoring has an important place in neuro-intensive care for patients with&#xD;
      severe head trauma and severe meningeal hemorrhage.&#xD;
&#xD;
      Until now the assessment of ICP requires invasive methods, with a pressure transducer either&#xD;
      within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is&#xD;
      performed in a neurosurgery department. These invasive methods have also disadvantages:&#xD;
      highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the&#xD;
      development of a non invasive method. The Biophysics Laboratory (School of Medicine of&#xD;
      Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional&#xD;
      activities of the outer hair cells in the cochlea.&#xD;
&#xD;
      Cochlear activities' recording is non-invasive and technically simple. A probe is gently&#xD;
      inserted into the outer portion of the external ear canal.&#xD;
&#xD;
      Anatomical studies showed communication between the subarachnoid spaces and the perilymphatic&#xD;
      compartment by the cochlear aqueduct. Thereby, increases in ICP are transferred to increases&#xD;
      in intra-cochlear pressure, which is detected as modifications in cochlear activities.&#xD;
&#xD;
      CSF dynamic tests, as constant flow infusion test, are conducted in patients in the diagnosis&#xD;
      of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through a lumbar&#xD;
      needle, into the CSF space at a constant rate, and the corresponding rise in ICP is&#xD;
      registered and analyzed.&#xD;
&#xD;
      The objective of this study is to assess prospectively the accuracy and the precision of a&#xD;
      new method for non invasive ICP measurement (using cochlear activities) compared with&#xD;
      invasive gold standard CSF pressure measurement during CSF dynamic tests.&#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;
      Patients, from the neurosurgery department, investigated for 'normal pressure' chronic&#xD;
      hydrocephalus are involved in CSF dynamic test. This complex protocol, including infusion&#xD;
      test and invasive CSF monitoring, is needed in order to confirm the diagnosis. CSF dynamic&#xD;
      tests, a socalled 'perfusion test', are performed in an operating theater, the patient had to&#xD;
      be awake but sedated. During perfusion test, electrophysiological cochlear activities are&#xD;
      measured with a gold tiptrode (Etymotic Research, Elk Grove Village, Ill) gently inserted&#xD;
      into the ear canal.&#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;
      Previously animal studies have shown that the phase of CM is sensitive to ICP changes and CM&#xD;
      phase shifts exhibit the same time course as those of otoacoustic emissions (DPOAEs).&#xD;
&#xD;
      The phase changes of CM can indeed be used as a non-invasive tool for monitoring&#xD;
      intralabyrinthine and intracranial pressures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2010</start_date>
  <completion_date type="Anticipated">September 2012</completion_date>
  <primary_completion_date type="Anticipated">September 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</measure>
    <time_frame>acquisition every minutes during &quot;Cerebrospinal Fluid Dynamic Test time(30-45min)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>IntraCranialPressure Variations</measure>
    <time_frame>every minutes during CerebroSpinal Fluid dynamic test time (30-45min)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Chronic Hydrocephalus</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 suspected chronic hydrocephalus, undergoing a CSF dynamic test&#xD;
             (perfusion test)&#xD;
&#xD;
          -  Age greater than 18&#xD;
&#xD;
          -  Subject provides written informed consent, or consent form signed by a close relative&#xD;
             (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 to sign a consent form&#xD;
&#xD;
               -  under otoscopy, presence of obstruction of the ear canal with wax (cerumen).&#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>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontefrrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2012</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>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</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 measurement</keyword>
  <keyword>intracranial pressure</keyword>
  <keyword>adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</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/NCT01685450
org study id: CHU 0123
secondary id: 2010-A00266-33
nct id: NCT01685450
lead sponsor: 
collaborator: 
The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal
      fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases.
      Continuous ICP monitoring has an important place in neuro-intensive care for patients with
      severe head trauma and severe meningeal hemorrhage.

      Until now the assessment of ICP requires invasive methods, with a pressure transducer either
      within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is
      performed in a neurosurgery department. These invasive methods have also disadvantages:
      highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the
      development of a non invasive method. The Biophysics Laboratory (School of Medicine of
      Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional
      activities of the outer hair cells in the cochlea.

      Cochlear activities' recording is non-invasive and technically simple. A probe is gently
      inserted into the outer portion of the external ear canal.

      Anatomical studies showed communication between the subarachnoid spaces and the perilymphatic
      compartment by the cochlear aqueduct. Thereby, increases in ICP are transferred to increases
      in intra-cochlear pressure, which is detected as modifications in cochlear activities.

      CSF dynamic tests, as constant flow infusion test, are conducted in patients in the diagnosis
      of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through a lumbar
      needle, into the CSF space at a constant rate, and the corresponding rise in ICP is
      registered and analyzed.

      The objective of this study is to assess prospectively the accuracy and the precision of a
      new method for non invasive ICP measurement (using cochlear activities) compared with
      invasive gold standard CSF pressure measurement during CSF dynamic tests.
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.

      Patients, from the neurosurgery department, investigated for 'normal pressure' chronic
      hydrocephalus are involved in CSF dynamic test. This complex protocol, including infusion
      test and invasive CSF monitoring, is needed in order to confirm the diagnosis. CSF dynamic
      tests, a socalled 'perfusion test', are performed in an operating theater, the patient had to
      be awake but sedated. During perfusion test, electrophysiological cochlear activities are
      measured with a gold tiptrode (Etymotic Research, Elk Grove Village, Ill) gently inserted
      into the ear canal.

      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.

      Previously animal studies have shown that the phase of CM is sensitive to ICP changes and CM
      phase shifts exhibit the same time course as those of otoacoustic emissions (DPOAEs).

      The phase changes of CM can indeed be used as a non-invasive tool for monitoring
      intralabyrinthine and intracranial pressures.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: Cochlear Microphonic Potential
time frame: acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)
measure: IntraCranialPressure Variations
time frame: every minutes during CerebroSpinal Fluid dynamic test time (30-45min)
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
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Hydrocephalus