<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/NCT01686516</url>
  </required_header>
  <id_info>
    <org_study_id>C10-58</org_study_id>
    <secondary_id>2011-A00034-37</secondary_id>
    <nct_id>NCT01686516</nct_id>
  </id_info>
  <brief_title>Synaptic Plasticity Imaging With Diffusion MRI</brief_title>
  <official_title>Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diffusion MRI employed in functional imaging has the potential to probe directly brain&#xD;
      activation instead of blood changes like the BOLD technique. The researchers investigated&#xD;
      these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion&#xD;
      functional MRI as well as anatomical (venography, tractography by diffusion) features in&#xD;
      young and aged subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging&#xD;
      (DWI) of the brain :&#xD;
&#xD;
        -  functional imaging using DWI and BOLD&#xD;
&#xD;
        -  anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue&#xD;
           microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used&#xD;
           anatomical imaging like T1 maps and susceptibility-based maps.&#xD;
&#xD;
      First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was&#xD;
      explored to obtain activation of brain following visual stimulations. These modality was&#xD;
      compared to BOLD and anatomical venography.&#xD;
&#xD;
      The DWI exams for anatomical (tractography) used both high angular resolution directional&#xD;
      diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain&#xD;
      precise knowledge about tissue microstructure.&#xD;
&#xD;
      Study was approved by the National French Institute of Health and by french organism for&#xD;
      biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for&#xD;
      eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to&#xD;
      aged healthy people (60-80 years).&#xD;
&#xD;
      Then, anatomical studies are devoted to obtain microstructures information about brain areas&#xD;
      that are changed with age, and to validate fully the feasibility of the DfMRI approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2011</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">35</enrollment>
  <condition>&quot;Brain Aging&quot;</condition>
  <eligibility>
    <study_pop>
      <textblock>
        population free of any psychological or organic troubles, with no metal inclusions for MRI&#xD;
        convenience.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 20-30 years&#xD;
&#xD;
          -  60-80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychological or organic trouble&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Renaud NICOLAS, PhD</last_name>
    <phone>(+33)7 77 05 76 75</phone>
    <email>rnd.nicolas@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Inserm U 825</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renaud NICOLAS, PhD</last_name>
      <phone>(+33)7 77 05 76 75</phone>
      <email>rnd.nicolas@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>age</keyword>
  <keyword>microstructure</keyword>
  <keyword>diffusion MRI</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/NCT01686516
org study id: C10-58
secondary id: 2011-A00034-37
nct id: NCT01686516
lead sponsor: 
has dmc: No
Diffusion MRI employed in functional imaging has the potential to probe directly brain
      activation instead of blood changes like the BOLD technique. The researchers investigated
      these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion
      functional MRI as well as anatomical (venography, tractography by diffusion) features in
      young and aged subjects.
This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging
      (DWI) of the brain :

        -  functional imaging using DWI and BOLD

        -  anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue
           microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used
           anatomical imaging like T1 maps and susceptibility-based maps.

      First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was
      explored to obtain activation of brain following visual stimulations. These modality was
      compared to BOLD and anatomical venography.

      The DWI exams for anatomical (tractography) used both high angular resolution directional
      diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain
      precise knowledge about tissue microstructure.

      Study was approved by the National French Institute of Health and by french organism for
      biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for
      eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to
      aged healthy people (60-80 years).

      Then, anatomical studies are devoted to obtain microstructures information about brain areas
      that are changed with age, and to validate fully the feasibility of the DfMRI approach.
observational model: Case-Crossover
time perspective: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Renaud NICOLAS, PhD
phone: (+33)7 77 05 76 75
email: rnd.nicolas@gmail.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor