<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/NCT03295864</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/36</org_study_id>
    <nct_id>NCT03295864</nct_id>
  </id_info>
  <brief_title>Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment</brief_title>
  <acronym>MCoto</acronym>
  <official_title>Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the value of multifrequency tympanometry between patients&#xD;
      with surgical indication of treatment for a Chiari type I malformation and healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevalence of Chiari type I malformation in population is between 0.1% and 0.5%. Chiari type&#xD;
      I malformation is responsive in perturbation of the cerebro spinal fluid flow at the&#xD;
      cranio-cervical junction. Those perturbations caused headaches, and various otological&#xD;
      symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis…). The surgical treatment&#xD;
      consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the&#xD;
      cranio-cervical junction. Symptoms are due to increasing of the pressure in the cerebellar&#xD;
      fossa. 81% of the patients with Chiari type 1 malformation suffer of sub clinical otological&#xD;
      perturbations especially alteration of the vestibular test.&#xD;
&#xD;
      In the literature, hearing performance could be normalized after posterior fossa&#xD;
      decompression. Furthermore, the multifrequency tympanometry measurement and particularly the&#xD;
      width of conductance tympanograms at 2 kHz shows that variations of the cerebro spinal fluid&#xD;
      pressure have consequences on the pressure of the perilymph.&#xD;
&#xD;
      Investigator's hypothesis is that tympanometry (conductance) could be an effective test to&#xD;
      show the variation of the cerebro spinal fluid pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">February 17, 2020</completion_date>
  <primary_completion_date type="Actual">February 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Width of conductance tympanograms at 2 kHz measurement</measure>
    <time_frame>Inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multifrequency tympanometry</measure>
    <time_frame>Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resonance frequency</measure>
    <time_frame>Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Audiometric parameters</measure>
    <time_frame>Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Otological symptoms</measure>
    <time_frame>Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measurement with Headache Impact Test</measure>
    <time_frame>Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebro spinal fluid pressure of the cranio cervical junction</measure>
    <time_frame>Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Arnold-Chiari Malformation, Type 1</condition>
  <arm_group>
    <arm_group_label>Patients with Chiari type 1 malformation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tympanometry measurement at inclusion and 6 months after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Multifrequency tympanometry at Inclusion</intervention_name>
    <description>Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with Chiari type 1 malformation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Multifrequency tympanometry 6 month after surgery</intervention_name>
    <description>Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient</description>
    <arm_group_label>Patients with Chiari type 1 malformation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Chiari type I malformation proved at MRI or CT-scan with an indication of cranio&#xD;
             cervical decompression.&#xD;
&#xD;
          -  Patients between 18 and 60 years old.&#xD;
&#xD;
          -  Patient should benefit of the national health care system&#xD;
&#xD;
          -  Agreement of the patient&#xD;
&#xD;
        Inclusion criteria for healthy volunteers:&#xD;
&#xD;
          -  Between 18 and 60 years old.&#xD;
&#xD;
          -  Free of otologic pathology&#xD;
&#xD;
          -  Benefit of the national health care system&#xD;
&#xD;
          -  Agreement of the volunteers&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Acute hydrocephaly&#xD;
&#xD;
          -  Other type of Chiari disease (induced…)&#xD;
&#xD;
          -  Medical history of neurosurgery&#xD;
&#xD;
          -  Contraindication for MRI&#xD;
&#xD;
          -  Cophosis&#xD;
&#xD;
          -  Chronic otitis&#xD;
&#xD;
          -  Medical history of ontological surgery&#xD;
&#xD;
          -  Tympanic perforation&#xD;
&#xD;
          -  Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with&#xD;
             abolition of stapedial reflex&#xD;
&#xD;
          -  Pregnant women or nursing women&#xD;
&#xD;
          -  Protected adults by French laws&#xD;
&#xD;
        Exclusion criteria for healthy volunteers:&#xD;
&#xD;
          -  Medical history of neurosurgery&#xD;
&#xD;
          -  Cophosis&#xD;
&#xD;
          -  Chronic otitis&#xD;
&#xD;
          -  Medical history of ontological surgery&#xD;
&#xD;
          -  Tympanic perforation&#xD;
&#xD;
          -  Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with&#xD;
             abolition of stapedial reflex&#xD;
&#xD;
          -  Pregnant women or nursing women&#xD;
&#xD;
          -  Medical history of Chiari malformation&#xD;
&#xD;
          -  Chronic headaches or neck pain&#xD;
&#xD;
          -  Protected adults by French laws&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine BENARD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>USMR - CHU de Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arnold-Chiari Malformation, Type 1</keyword>
  <keyword>Multifrequency tympanometry</keyword>
  <keyword>Inner ear pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arnold-Chiari Malformation</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT03295864
org study id: CHUBX 2016/36
nct id: NCT03295864
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the value of multifrequency tympanometry between patients
      with surgical indication of treatment for a Chiari type I malformation and healthy
      volunteers.
Prevalence of Chiari type I malformation in population is between 0.1% and 0.5%. Chiari type
      I malformation is responsive in perturbation of the cerebro spinal fluid flow at the
      cranio-cervical junction. Those perturbations caused headaches, and various otological
      symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis…). The surgical treatment
      consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the
      cranio-cervical junction. Symptoms are due to increasing of the pressure in the cerebellar
      fossa. 81% of the patients with Chiari type 1 malformation suffer of sub clinical otological
      perturbations especially alteration of the vestibular test.

      In the literature, hearing performance could be normalized after posterior fossa
      decompression. Furthermore, the multifrequency tympanometry measurement and particularly the
      width of conductance tympanograms at 2 kHz shows that variations of the cerebro spinal fluid
      pressure have consequences on the pressure of the perilymph.

      Investigator's hypothesis is that tympanometry (conductance) could be an effective test to
      show the variation of the cerebro spinal fluid pressure.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Width of conductance tympanograms at 2 kHz measurement
time frame: Inclusion
measure: Multifrequency tympanometry
time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
measure: Resonance frequency
time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
measure: Audiometric parameters
time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
measure: Otological symptoms
time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
measure: Pain measurement with Headache Impact Test
time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
measure: Cerebro spinal fluid pressure of the cranio cervical junction
time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
arm group label: Patients with Chiari type 1 malformation
arm group type: Experimental
description: Tympanometry measurement at inclusion and 6 months after surgery
arm group label: Healthy volunteers
arm group type: Experimental
description: Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).
intervention type: Diagnostic Test
intervention name: Multifrequency tympanometry at Inclusion
description: Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion
arm group label: Healthy volunteers
arm group label: Patients with Chiari type 1 malformation
intervention type: Diagnostic Test
intervention name: Multifrequency tympanometry 6 month after surgery
description: Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient
arm group label: Patients with Chiari type 1 malformation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antoine BENARD, MD
role: Study Chair
affiliation: USMR - CHU de Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Arnold-Chiari Malformation
mesh term: Congenital Abnormalities