<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/NCT01718249</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0126</org_study_id>
    <secondary_id>2011-A00300-41</secondary_id>
    <nct_id>NCT01718249</nct_id>
  </id_info>
  <brief_title>Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness</brief_title>
  <acronym>Post-coma DBS</acronym>
  <official_title>Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation de l'Avenir</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest&#xD;
      that deep brain stimulation of the thalamic-tegmental reticular system could improve&#xD;
      consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this&#xD;
      protocol is to study the effects of deep brain stimulation on conscious behavior, using a&#xD;
      patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised&#xD;
      (CRS-R) as clinical assessment criterion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total length of inclusion for a patient: 10 months (2 months before electrodes implantation,&#xD;
      8 months after).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CRS-R scores (Coma Recovery Scale-Revised)</measure>
    <time_frame>after 2 months and after 7 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>signs of awakening at night</measure>
    <time_frame>during the 10 months of the study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>zerit burden interview</measure>
    <time_frame>at 1 month and at 10 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)</condition>
  <arm_group>
    <arm_group_label>deep brain stimulation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Implantable neurostimulation system</intervention_name>
    <arm_group_label>deep brain stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients stably in Vegetative state or Minimally conscious state, since at least 6&#xD;
             months after cerebrovascular accident and 1 year after traumatic brain injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebral death, Locked-In Syndrome, blindness, deafness&#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>Jean-Jacques LEMAIRE</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>November 2017</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Deep Brain Stimulation (DBS)</keyword>
  <keyword>Post-coma</keyword>
  <keyword>Consciousness</keyword>
  <keyword>Vegetative state</keyword>
  <keyword>Minimally conscious state</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
    <mesh_term>Coma</mesh_term>
    <mesh_term>Persistent Vegetative State</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/NCT01718249
org study id: CHU-0126
secondary id: 2011-A00300-41
nct id: NCT01718249
lead sponsor: 
collaborator: 
collaborator: 
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest
      that deep brain stimulation of the thalamic-tegmental reticular system could improve
      consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this
      protocol is to study the effects of deep brain stimulation on conscious behavior, using a
      patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised
      (CRS-R) as clinical assessment criterion.
Total length of inclusion for a patient: 10 months (2 months before electrodes implantation,
      8 months after).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: CRS-R scores (Coma Recovery Scale-Revised)
time frame: after 2 months and after 7 months
measure: signs of awakening at night
time frame: during the 10 months of the study
measure: zerit burden interview
time frame: at 1 month and at 10 months
arm group label: deep brain stimulation
arm group type: Other
intervention type: Other
intervention name: Implantable neurostimulation system
arm group label: deep brain stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Jacques LEMAIRE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Consciousness Disorders
mesh term: Coma
mesh term: Persistent Vegetative State