<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/NCT03039166</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01785-46</org_study_id>
    <secondary_id>2016-46</secondary_id>
    <nct_id>NCT03039166</nct_id>
  </id_info>
  <brief_title>Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI</brief_title>
  <official_title>Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as&#xD;
      well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on&#xD;
      functional dysfunction not directly related to each disease, but that could induce common&#xD;
      syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.&#xD;
&#xD;
      The objective here is to test this hypothesis and provides better understandings on&#xD;
      pathophysiological processes affecting those highly connected regions in 'diffuse' and&#xD;
      'focal' neurological diseases.&#xD;
&#xD;
      The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS,&#xD;
      cognitive rehabilitation ...).&#xD;
&#xD;
      Practically, the investigators will explore 200 patients classified in 5 cohorts of 40&#xD;
      patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to&#xD;
      assess structural and functional brain connectivity implemented on the human 7T MR scanner&#xD;
      equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).&#xD;
&#xD;
      In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium)&#xD;
      mapping will complement the MR protocol to characterize the pathophysiological processes of&#xD;
      hub injury. Sixty healthy controls will also be explored wih the same protocol for normal&#xD;
      database.&#xD;
&#xD;
      The proposal aims at characterizing and comparing from a morphological-functional point of&#xD;
      view, the hub regions of patients suffering from these five diseases, to demonstrate the&#xD;
      pertinence to preserve hub integrity as a major therapeutic target whatever the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 2017</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Index of reorganization of the structural hubs (ks-Degree)</measure>
    <time_frame>5years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentrations of sodium within hubs</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations of Glutamate/Glutamine within hubs</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cortical Thicknesses within hubs</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron accumulation within hubs</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Diffuse Diseases</condition>
  <arm_group>
    <arm_group_label>parkinson</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>partial epilepsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>alzheimer disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>multiple sclerosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>amyotrophic lateral sclerosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI 7T</intervention_name>
    <arm_group_label>alzheimer disease</arm_group_label>
    <arm_group_label>amyotrophic lateral sclerosis</arm_group_label>
    <arm_group_label>healthy control patients</arm_group_label>
    <arm_group_label>multiple sclerosis</arm_group_label>
    <arm_group_label>parkinson</arm_group_label>
    <arm_group_label>partial epilepsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI 3 T</intervention_name>
    <arm_group_label>alzheimer disease</arm_group_label>
    <arm_group_label>amyotrophic lateral sclerosis</arm_group_label>
    <arm_group_label>healthy control patients</arm_group_label>
    <arm_group_label>multiple sclerosis</arm_group_label>
    <arm_group_label>parkinson</arm_group_label>
    <arm_group_label>partial epilepsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <arm_group_label>multiple sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person female or male, more than 18-year-old,&#xD;
&#xD;
          -  Person presenting unchecked general disease such as severe cancer, autoimmune disease,&#xD;
             hepatic insufficiency, severe or untreated, shady arterial high blood pressure of the&#xD;
             conduction or the disorder of the rhythm&#xD;
&#xD;
          -  Person presenting chronic psychiatric disease, insane syndrome.&#xD;
&#xD;
          -  Person presenting contraindication to the realization of an examination by MRI&#xD;
             (metallic claustrophobia, foreign body, pacemakers),&#xD;
&#xD;
          -  Person benefiting from a social security cover,&#xD;
&#xD;
          -  Person having read, understood and signed an informed consent after information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Claustrophobia,&#xD;
&#xD;
          -  Metallic foreign bodies,&#xD;
&#xD;
          -  Pacemakers,&#xD;
&#xD;
          -  Severe renal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine GEINDRE</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>maxime GUYE</last_name>
    <email>maxime.guye@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiatnce Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>ALEXANDRA GIULIANI</last_name>
      <email>drci@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>MAXIME GUYE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03039166
org study id: 2016-A01785-46
secondary id: 2016-46
nct id: NCT03039166
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as
      well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on
      functional dysfunction not directly related to each disease, but that could induce common
      syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.

      The objective here is to test this hypothesis and provides better understandings on
      pathophysiological processes affecting those highly connected regions in 'diffuse' and
      'focal' neurological diseases.

      The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS,
      cognitive rehabilitation ...).

      Practically, the investigators will explore 200 patients classified in 5 cohorts of 40
      patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to
      assess structural and functional brain connectivity implemented on the human 7T MR scanner
      equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).

      In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium)
      mapping will complement the MR protocol to characterize the pathophysiological processes of
      hub injury. Sixty healthy controls will also be explored wih the same protocol for normal
      database.

      The proposal aims at characterizing and comparing from a morphological-functional point of
      view, the hub regions of patients suffering from these five diseases, to demonstrate the
      pertinence to preserve hub integrity as a major therapeutic target whatever the disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Index of reorganization of the structural hubs (ks-Degree)
time frame: 5years
measure: Concentrations of sodium within hubs
time frame: 5 years
measure: Concentrations of Glutamate/Glutamine within hubs
time frame: 5 years
measure: cortical Thicknesses within hubs
time frame: 5 years
measure: Iron accumulation within hubs
time frame: 5 years
arm group label: parkinson
arm group type: Experimental
arm group label: partial epilepsy
arm group type: Experimental
arm group label: alzheimer disease
arm group type: Experimental
arm group label: multiple sclerosis
arm group type: Experimental
arm group label: amyotrophic lateral sclerosis
arm group type: Experimental
arm group label: healthy control patients
arm group type: Active Comparator
intervention type: Device
intervention name: MRI 7T
arm group label: alzheimer disease
arm group label: amyotrophic lateral sclerosis
arm group label: healthy control patients
arm group label: multiple sclerosis
arm group label: parkinson
arm group label: partial epilepsy
intervention type: Device
intervention name: MRI 3 T
arm group label: alzheimer disease
arm group label: amyotrophic lateral sclerosis
arm group label: healthy control patients
arm group label: multiple sclerosis
arm group label: parkinson
arm group label: partial epilepsy
intervention type: Biological
intervention name: blood sample
arm group label: multiple sclerosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine GEINDRE
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
last name: maxime GUYE
email: maxime.guye@ap-hm.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Nervous System Diseases
sharing ipd: No