<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/NCT02201927</url>
  </required_header>
  <id_info>
    <org_study_id>2013-A01243-42/1</org_study_id>
    <nct_id>NCT02201927</nct_id>
  </id_info>
  <brief_title>Stimulation Galvanique Vestibulaire</brief_title>
  <acronym>GVS</acronym>
  <official_title>Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Versailles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients&#xD;
      suffering right posterior parietal lesions fail to update their own position after a body&#xD;
      rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal&#xD;
      cortex and reduces symptoms of spatial neglect, another disability frequently encountered&#xD;
      after right posterior parietal lesion. The aims of this study are to confirm posterior&#xD;
      parietal involvement in automatic updating of body-centered spatial relationships and to&#xD;
      evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups&#xD;
      of adults are compared before and during galvanic vestibular stimulation on a pointing task:&#xD;
      a healthy control group, a brain-injured control group with stroke lesions sparing right&#xD;
      posterior parietal cortex and a group of stroke patients with right posterior parietal&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of performance&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>deviation from target score</measure>
    <time_frame>30 min</time_frame>
    <description>difference in degree between the actual and target score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>deviation from target &quot;straight ahead&quot;</measure>
    <time_frame>30min</time_frame>
    <description>difference in degree between the actual straight ahead and target score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>deviation rightward line bisection</measure>
    <time_frame>30min</time_frame>
    <description>percentage difference between actual and target score on test &quot;deviation right line bisection&quot;</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Hypertensive Hemorrhage of Right Parietal Lobe</condition>
  <arm_group>
    <arm_group_label>patient with right parietal lobe lesion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with right parietal lobe lesion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patient stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient with cerebral vascular accident</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>galvanic vestibular stimulation</intervention_name>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_label>patient stroke</arm_group_label>
    <arm_group_label>patient with right parietal lobe lesion</arm_group_label>
    <other_name>deviation from target score with and without galvanic vestibular stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with right posterieur parietal lobe lesion&#xD;
&#xD;
          -  patient with cerebral vascular stroke&#xD;
&#xD;
          -  healthy volonteers Age greater than or equal to 18 written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient's refusal to participate to the study&#xD;
&#xD;
          -  inability to cooperate&#xD;
&#xD;
          -  cognitive trouble&#xD;
&#xD;
          -  epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruet Alexis, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOPITAL RAYMOND POINCARE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Raymond Poincare Mpr</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>galvanic vestibular stimulation</keyword>
  <keyword>right parietal lobe lesion</keyword>
  <keyword>egocentric space</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02201927
org study id: 2013-A01243-42/1
nct id: NCT02201927
lead sponsor: 
collaborator: 
has dmc: Yes
Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients
      suffering right posterior parietal lesions fail to update their own position after a body
      rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal
      cortex and reduces symptoms of spatial neglect, another disability frequently encountered
      after right posterior parietal lesion. The aims of this study are to confirm posterior
      parietal involvement in automatic updating of body-centered spatial relationships and to
      evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups
      of adults are compared before and during galvanic vestibular stimulation on a pointing task:
      a healthy control group, a brain-injured control group with stroke lesions sparing right
      posterior parietal cortex and a group of stroke patients with right posterior parietal
      lesions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: deviation from target score
time frame: 30 min
description: difference in degree between the actual and target score
measure: deviation from target "straight ahead"
time frame: 30min
description: difference in degree between the actual straight ahead and target score
measure: deviation rightward line bisection
time frame: 30min
description: percentage difference between actual and target score on test "deviation right line bisection"
arm group label: patient with right parietal lobe lesion
arm group type: Experimental
description: Patient with right parietal lobe lesion
arm group label: patient stroke
arm group type: Experimental
description: patient with cerebral vascular accident
arm group label: healthy volunteers
arm group type: Experimental
description: healthy volunteers
intervention type: Device
intervention name: galvanic vestibular stimulation
arm group label: healthy volunteers
arm group label: patient stroke
arm group label: patient with right parietal lobe lesion
other name: deviation from target score with and without galvanic vestibular stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ruet Alexis, PHD
role: Principal Investigator
affiliation: HOPITAL RAYMOND POINCARE
facility: 
country: France
responsible party type: Sponsor
mesh term: Hemorrhage