<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/NCT03286686</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0341</org_study_id>
    <secondary_id>2017-A02562-51</secondary_id>
    <nct_id>NCT03286686</nct_id>
  </id_info>
  <brief_title>Sensori-motor and Perceptual Functions of the PPC.</brief_title>
  <acronym>PPCfonctions</acronym>
  <official_title>Sensori-motor and Perceptual Functions of the Posterior Parietal Cortex (PPC) in Patients With Optic Ataxia (AO) and Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      To produce hand's movement directed towards a target, the investigator must combine several&#xD;
      sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is&#xD;
      a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a&#xD;
      visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.&#xD;
&#xD;
      The aim of the study is to understand the different functions of the PPC and especially how&#xD;
      the processes of spatial coding of the sensory information influences perception and motor&#xD;
      planning.&#xD;
&#xD;
      In this study, the investigator want to explore the sensory motor and the perceptual&#xD;
      performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral&#xD;
      tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2018</start_date>
  <completion_date type="Anticipated">February 22, 2029</completion_date>
  <primary_completion_date type="Anticipated">February 22, 2029</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response error - number of pointing error</measure>
    <time_frame>Day 0 after each stimulation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>response error -measure of reaction times</measure>
    <time_frame>Day 0 after each stimulation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>response error - percentage of right responses</measure>
    <time_frame>Day 0 after each stimulation</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Optic Ataxia</condition>
  <arm_group>
    <arm_group_label>Experience 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experience 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experience 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experience 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experience 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experience 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>point targets</intervention_name>
    <description>In the experiences 1 and 2, the participant needs to point different visual targets (LED) in the dark.</description>
    <arm_group_label>Experience 1</arm_group_label>
    <arm_group_label>Experience 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>tactile stimulation</intervention_name>
    <description>In the experience 3, a tactile stimulation is applied to the middle finger of the 2 hands. The participant needs to indicate into a microphone when he feels the stimulation.</description>
    <arm_group_label>Experience 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>visual images</intervention_name>
    <description>Target dots or visual images are presented on a computer screen. The participant is required to point to the targets or to react as soon as possible by pressing a response button when they are detected.</description>
    <arm_group_label>Experience 4</arm_group_label>
    <arm_group_label>Experience 5</arm_group_label>
    <arm_group_label>Experience 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients and healthy subjects:&#xD;
&#xD;
          -  male and female, age from 18 to 75 years included&#xD;
&#xD;
          -  normal vision or corrected vision&#xD;
&#xD;
          -  covered by social security&#xD;
&#xD;
          -  signed written informed consent&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  neurological injury in posterior parietal cortex supported by a cerebral MRI&#xD;
&#xD;
          -  present optic ataxia symptoms Healthy subjects&#xD;
&#xD;
          -  no known neurological injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - unable to comply with the tasks (neurological, psychiatric, sensory or motor troubles)&#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>Laure PISELLA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM U1028 - Impact - CRNL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laure PISELLA, PhD</last_name>
    <phone>4 72 91 34 05</phone>
    <phone_ext>+33</phone_ext>
    <email>laure.pisella@inserm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>U1028 INSERM - CNRS UMR 5292 Equipe ImpAct</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laure Pisella, PhD</last_name>
      <phone>4 72 91 34 05</phone>
      <phone_ext>+33</phone_ext>
      <email>laure.pisella@inserm.fr</email>
    </contact>
    <investigator>
      <last_name>Laure Pisella, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophie JACQUIN-COURTOIS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>optic ataxia</keyword>
  <keyword>posterior parietal cortex functions</keyword>
  <keyword>multisensory integration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ataxia</mesh_term>
    <mesh_term>Cerebellar Ataxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03286686
org study id: 69HCL17_0341
secondary id: 2017-A02562-51
nct id: NCT03286686
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To produce hand's movement directed towards a target, the investigator must combine several
      sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is
      a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a
      visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.

      The aim of the study is to understand the different functions of the PPC and especially how
      the processes of spatial coding of the sensory information influences perception and motor
      planning.

      In this study, the investigator want to explore the sensory motor and the perceptual
      performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral
      tests.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: response error - number of pointing error
time frame: Day 0 after each stimulation
measure: response error -measure of reaction times
time frame: Day 0 after each stimulation
measure: response error - percentage of right responses
time frame: Day 0 after each stimulation
arm group label: Experience 1
arm group type: Experimental
arm group label: Experience 2
arm group type: Experimental
arm group label: Experience 3
arm group type: Experimental
arm group label: Experience 4
arm group type: Experimental
arm group label: Experience 5
arm group type: Experimental
arm group label: Experience 6
arm group type: Experimental
intervention type: Behavioral
intervention name: point targets
description: In the experiences 1 and 2, the participant needs to point different visual targets (LED) in the dark.
arm group label: Experience 1
arm group label: Experience 2
intervention type: Behavioral
intervention name: tactile stimulation
description: In the experience 3, a tactile stimulation is applied to the middle finger of the 2 hands. The participant needs to indicate into a microphone when he feels the stimulation.
arm group label: Experience 3
intervention type: Behavioral
intervention name: visual images
description: Target dots or visual images are presented on a computer screen. The participant is required to point to the targets or to react as soon as possible by pressing a response button when they are detected.
arm group label: Experience 4
arm group label: Experience 5
arm group label: Experience 6
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laure PISELLA, PhD
role: Principal Investigator
affiliation: INSERM U1028 - Impact - CRNL
last name: Laure PISELLA, PhD
phone: 4 72 91 34 05
phone ext: +33
email: laure.pisella@inserm.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Ataxia
mesh term: Cerebellar Ataxia
sharing ipd: Undecided