<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/NCT02189460</url>
  </required_header>
  <id_info>
    <org_study_id>2014-AZ00569-38</org_study_id>
    <nct_id>NCT02189460</nct_id>
  </id_info>
  <brief_title>Effect of Normal Aging on Language Processing</brief_title>
  <acronym>SEMVIE</acronym>
  <official_title>Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand the effect of age on language abilities. The&#xD;
      investigators aim at investigating the cerebral modifications that take place in normal&#xD;
      aging, at the functional an anatomical level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough subjects&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Oxygen Level Dependent functional MRI</measure>
    <time_frame>There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.</time_frame>
    <description>We use 3 functional tasks using block paradigm: Object naming, Verbal generation and semantic judgment, to elicit BOLD response using fMRI in order to compare functional activation patterns between subjects.&#xD;
We also use hypercapnic challenge to elicit BOLD response in order to obtain Cerebral Vascular Reactivity properties of subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomical MRI</measure>
    <time_frame>There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.</time_frame>
    <description>We use Voxel Based Morphometry to compare cortical volume (grey matter) between subjects.&#xD;
We also use tractography Diffusion Tensor Imaging to compare white matter properties between subjects.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">33</enrollment>
  <condition>Cognition</condition>
  <arm_group>
    <arm_group_label>Healthy adults</arm_group_label>
    <description>20 young adults aged between 30 and 50 years old. 20 middle aged adults aged between 50 and 70 years old. 20 older adults of 70 years old and more.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        60 healthy adults will participate to the study. There will be 3 age groups: 30-50, 50-70,&#xD;
        &gt; 70 years. Ech group will contain 20 volunteers.&#xD;
&#xD;
        The volunteers are recruited by means of ads on Laboratory websites and Universities.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 30 years and above&#xD;
&#xD;
          -  Right handed&#xD;
&#xD;
          -  French native speakers&#xD;
&#xD;
          -  Affiliation to French social security (Sécurité Sociale)&#xD;
&#xD;
          -  Medical interview&#xD;
&#xD;
          -  Consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebral or respiratory pathologies&#xD;
&#xD;
          -  Any MRI contrindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Krainik, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Monica Baciu, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRMaGe facility</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognition</keyword>
  <!-- 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/NCT02189460
org study id: 2014-AZ00569-38
nct id: NCT02189460
lead sponsor: 
has dmc: Yes
The purpose of this study is to understand the effect of age on language abilities. The
      investigators aim at investigating the cerebral modifications that take place in normal
      aging, at the functional an anatomical level.
observational model: Other
time perspective: Prospective
measure: Blood Oxygen Level Dependent functional MRI
time frame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.
description: We use 3 functional tasks using block paradigm: Object naming, Verbal generation and semantic judgment, to elicit BOLD response using fMRI in order to compare functional activation patterns between subjects.
We also use hypercapnic challenge to elicit BOLD response in order to obtain Cerebral Vascular Reactivity properties of subjects.
measure: Anatomical MRI
time frame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.
description: We use Voxel Based Morphometry to compare cortical volume (grey matter) between subjects.
We also use tractography Diffusion Tensor Imaging to compare white matter properties between subjects.
arm group label: Healthy adults
description: 20 young adults aged between 30 and 50 years old. 20 middle aged adults aged between 50 and 70 years old. 20 older adults of 70 years old and more.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandre Krainik, Professor
role: Principal Investigator
affiliation: Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.
last name: Monica Baciu, Professor
role: Study Director
affiliation: Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.
facility: 
country: France
responsible party type: Sponsor