<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/NCT03040284</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-301</org_study_id>
    <secondary_id>2014-A01300-47</secondary_id>
    <nct_id>NCT03040284</nct_id>
  </id_info>
  <brief_title>Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage</brief_title>
  <acronym>HEMAPIC</acronym>
  <official_title>Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      In patients at risk of increased intracranial pressure (ICP), ICP measurements require&#xD;
      invasive transducers, usually with insertion of a catheter into the cranium, or through a&#xD;
      spinal tap. These invasive modalities involve risks and pain and they can be done only in&#xD;
      specialized care units, with a high associated cost.&#xD;
&#xD;
      A novel method for detecting changes in ICP has developed recently. The auditory hair cells&#xD;
      emit sounds and electric signals in response to sound, which can be easily detected and&#xD;
      measured non-invasively with the help of a microphone probe placed in the external ear canal&#xD;
      or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)&#xD;
      spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within&#xD;
      seconds.&#xD;
&#xD;
      The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically&#xD;
      used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical&#xD;
      signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with&#xD;
      a standard imaging method (TDM).&#xD;
&#xD;
      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another&#xD;
      disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes&#xD;
      patient clinical worsening and / or imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients at risk of increased intracranial pressure (ICP), ICP measurements require&#xD;
      invasive transducers, usually with insertion of a catheter into the cranium, or through a&#xD;
      spinal tap. These invasive modalities involve risks and pain and they can be done only in&#xD;
      specialized care units, with a high associated cost.&#xD;
&#xD;
      A novel method for detecting changes in ICP has developed recently. The auditory hair cells&#xD;
      emit sounds and electric signals in response to sound, which can be easily detected and&#xD;
      measured non-invasively with the help of a microphone probe placed in the external ear canal&#xD;
      or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)&#xD;
      spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within&#xD;
      seconds.&#xD;
&#xD;
      The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically&#xD;
      used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical&#xD;
      signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with&#xD;
      a standard imaging method (TDM).&#xD;
&#xD;
      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another&#xD;
      disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes&#xD;
      patient clinical worsening and / or imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of an intracranial pressure variation or increase</measure>
    <time_frame>at day 1</time_frame>
    <description>Presence of an intracranial pressure variation or increase when physician has diagnosed a clinical or imaging disorder of the cerebrospinal liquid flow with standard diagnose methods (composite outcome measure): clinical signs, TDM and assessment of bifrontal index.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of ICP before and after the development of disorder of the cerebrospinal liquid flow according to clinical sign and/or TDM.</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficiency of the measurement device on repetitive measurement during one year as evaluated by composite outcome measure: clinical signs, TDM.</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Aneurysmal Subarachnoid Hemorrhage, Familial</condition>
  <arm_group>
    <arm_group_label>aneurysmal subarachnoid hemorrhage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Echodia® hand-held equipment (ELIOS)</intervention_name>
    <arm_group_label>aneurysmal subarachnoid hemorrhage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients which had recently (few days) aneurysmal subarachnoid hemorrhage&#xD;
&#xD;
          -  Valid tympanometry test at least for one ear&#xD;
&#xD;
          -  Between 18 and 75 years of age&#xD;
&#xD;
          -  Cochlear response useful at least for an ear which has validate the tympanometry test&#xD;
&#xD;
          -  Written informed consent reviewed and signed by patient&#xD;
&#xD;
          -  Affiliation to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Invalid tympanometry test for the both ears&#xD;
&#xD;
          -  Collect of cochlear responses impossible for the ear or both ear which validate the&#xD;
             tympanometry test&#xD;
&#xD;
          -  Patient refusal after enlightened information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>0473751195</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-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Paul AVAN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>noninvasive monitoring</keyword>
  <keyword>intracranial pressure</keyword>
  <keyword>cochlear electrophysiology</keyword>
  <keyword>aneurysmal subarachnoid haemorrhage</keyword>
  <keyword>cerebrovascular disorders</keyword>
  <keyword>brain diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</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/NCT03040284
org study id: CHU-301
secondary id: 2014-A01300-47
nct id: NCT03040284
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In patients at risk of increased intracranial pressure (ICP), ICP measurements require
      invasive transducers, usually with insertion of a catheter into the cranium, or through a
      spinal tap. These invasive modalities involve risks and pain and they can be done only in
      specialized care units, with a high associated cost.

      A novel method for detecting changes in ICP has developed recently. The auditory hair cells
      emit sounds and electric signals in response to sound, which can be easily detected and
      measured non-invasively with the help of a microphone probe placed in the external ear canal
      or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)
      spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within
      seconds.

      The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically
      used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical
      signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with
      a standard imaging method (TDM).

      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another
      disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes
      patient clinical worsening and / or imaging.
In patients at risk of increased intracranial pressure (ICP), ICP measurements require
      invasive transducers, usually with insertion of a catheter into the cranium, or through a
      spinal tap. These invasive modalities involve risks and pain and they can be done only in
      specialized care units, with a high associated cost.

      A novel method for detecting changes in ICP has developed recently. The auditory hair cells
      emit sounds and electric signals in response to sound, which can be easily detected and
      measured non-invasively with the help of a microphone probe placed in the external ear canal
      or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)
      spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within
      seconds.

      The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically
      used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical
      signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with
      a standard imaging method (TDM).

      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another
      disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes
      patient clinical worsening and / or imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: open
measure: Presence of an intracranial pressure variation or increase
time frame: at day 1
description: Presence of an intracranial pressure variation or increase when physician has diagnosed a clinical or imaging disorder of the cerebrospinal liquid flow with standard diagnose methods (composite outcome measure): clinical signs, TDM and assessment of bifrontal index.
measure: Evolution of ICP before and after the development of disorder of the cerebrospinal liquid flow according to clinical sign and/or TDM.
time frame: at day 1
measure: Efficiency of the measurement device on repetitive measurement during one year as evaluated by composite outcome measure: clinical signs, TDM.
time frame: at day 1
arm group label: aneurysmal subarachnoid hemorrhage
arm group type: Experimental
intervention type: Device
intervention name: Echodia® hand-held equipment (ELIOS)
arm group label: aneurysmal subarachnoid hemorrhage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Patrick LACARIN
phone: 0473751195
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage