<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/NCT03010943</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01139-42</org_study_id>
    <nct_id>NCT03010943</nct_id>
  </id_info>
  <brief_title>Brain Awake Surgery Using Virtual Reality Headset</brief_title>
  <acronym>CERVO1</acronym>
  <official_title>Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      Feasibility and tolerance study of virtual reality headset for brain mapping during brain&#xD;
      awake surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Actual">April 24, 2020</completion_date>
  <primary_completion_date type="Actual">April 24, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.</measure>
    <time_frame>During awake surgery</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Brain Tumor</condition>
  <condition>Virtual Reality</condition>
  <arm_group>
    <arm_group_label>Brain surgery with virtual reality headset</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual reality headset</intervention_name>
    <description>Feasibility and tolerance</description>
    <arm_group_label>Brain surgery with virtual reality headset</arm_group_label>
    <other_name>awake craniotomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent&#xD;
             area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency&#xD;
&#xD;
          -  Any contra-indication to awake brain surgery&#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>Philippe MENEI, MDPHD</last_name>
    <role>Study Director</role>
    <affiliation>University hospital of Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Mazerand E, Le Renard M, Hue S, Lemee JM, Klinger E, Menei P. Intraoperative Subcortical Electrical Mapping of the Optic Tract in Awake Surgery Using a Virtual Reality Headset. World Neurosurg. 2017 Jan;97:424-430. doi: 10.1016/j.wneu.2016.10.031. Epub 2016 Oct 15.</citation>
    <PMID>27756671</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>glioma surgery</keyword>
  <keyword>awake craniotomy</keyword>
  <keyword>brain tumor</keyword>
  <keyword>glioma</keyword>
  <keyword>neurosurgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</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/NCT03010943
org study id: 2016-A01139-42
nct id: NCT03010943
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Feasibility and tolerance study of virtual reality headset for brain mapping during brain
      awake surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.
time frame: During awake surgery
arm group label: Brain surgery with virtual reality headset
arm group type: Experimental
intervention type: Device
intervention name: Virtual reality headset
description: Feasibility and tolerance
arm group label: Brain surgery with virtual reality headset
other name: awake craniotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe MENEI, MDPHD
role: Study Director
affiliation: University hospital of Angers
facility: 
country: France
citation: Mazerand E, Le Renard M, Hue S, Lemee JM, Klinger E, Menei P. Intraoperative Subcortical Electrical Mapping of the Optic Tract in Awake Surgery Using a Virtual Reality Headset. World Neurosurg. 2017 Jan;97:424-430. doi: 10.1016/j.wneu.2016.10.031. Epub 2016 Oct 15.
PMID: 27756671
responsible party type: Sponsor
mesh term: Brain Neoplasms