xml: <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/NCT05967832</url>
    </required_header>
    <id_info>
      <org_study_id>RCAPHM22_0378</org_study_id>
      <secondary_id>ID-RCB</secondary_id>
      <nct_id>NCT05967832</nct_id>
    </id_info>
    <brief_title>Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy</brief_title>
    <acronym>NARCO7T</acronym>
    <official_title>Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy: Pilot Study</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>
        This study is part of the research on type 1 narcolepsy, a neurological pathology affecting&#xD;
        mostly young subjects. The only biomarker currently available is the hypocretin assay, which&#xD;
        shows a level below 110 pg/mL. However, the interpretation of this biomarker has limitations:&#xD;
        the test is not widely available and it is rarely performed by practitioners. Even when&#xD;
        performed, the interpretation of the level may not be consistent with the phenotype&#xD;
        compatible with type 1 narcolepsy.&#xD;
  &#xD;
        This study therefore aims to develop new tools to reduce the diagnostic delay. This would be&#xD;
        the first study with 7T MRI that could achieve a level of spatial resolution sufficient to&#xD;
        highlight volume changes in small brain structures such as the lateral hypothalamus whose&#xD;
        narcolepsy-induced changes are not detected by lower resolution MRI.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">April 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 14, 2025</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>Hypothalamic morphological difference</measure>
      <time_frame>Month 0</time_frame>
      <description>Significant structural size difference between right and left lateral hypothalamus</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Microstructural abnormalities other than volume differences</measure>
      <time_frame>Month 0</time_frame>
      <description>Significant difference in Diffusion and T2* values in the lateral hypothalamus</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Structural changes in hypothalamic nuclei other than the lateral hypothalamus</measure>
      <time_frame>Month 0</time_frame>
      <description>Significant difference in volumes and T1 values in other regions of the posterior hypothalamus</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Narcolepsy Type 1</condition>
    <arm_group>
      <arm_group_label>Patients with type 1 narcolepsy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with type 1 narcolepsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>7T MRI</intervention_name>
      <description>Patients and healthy volunteers will have a 7T MRI</description>
      <arm_group_label>Healthy volunteers</arm_group_label>
      <arm_group_label>Patients with type 1 narcolepsy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for patients :&#xD;
  &#xD;
            1. Diagnosis of narcolepsy type 1 according to the diagnostic criteria of the&#xD;
               International Classification of sleep disorders version 3 (ICSD-3, American Academy of&#xD;
               Sleep Medicine, 2014) including a mean sleep latency of less than 8 minutes on the&#xD;
               iterative sleep latency test associated with at least two direct REM sleep onset and&#xD;
               the presence of cataplexy, and a cerebrospinal fluid hypocretin assay of less than 110&#xD;
               pg/ml performed by the reference radioimmunology (RIA) technique.&#xD;
  &#xD;
            2. Patient at least 18 years old&#xD;
  &#xD;
            3. Patient followed at the Narcolepsy and Rare Hypersomnias Competence Center, Timone&#xD;
               Hospital, Marseille&#xD;
  &#xD;
            4. Patient having signed an informed consent&#xD;
  &#xD;
            5. Patient who is a beneficiary of or affiliated to a social security system&#xD;
  &#xD;
          Exclusion Criteria for patient:&#xD;
  &#xD;
            1. Diagnosis of type 1 narcolepsy according to ICSD-3 criteria but without hypocretin&#xD;
               assay&#xD;
  &#xD;
            2. Narcolepsy secondary to another neurological pathology or presence of a comorbid&#xD;
               neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head&#xD;
               trauma, epilepsy)&#xD;
  &#xD;
            3. Protected patient: pregnant or breastfeeding woman, adult under guardianship or&#xD;
               curatorship&#xD;
  &#xD;
            4. Contraindication to the realization of a 7T MRI: patient wearing a pacemaker,&#xD;
               neurosurgical clips, artificial heart valve, surgical material or metal fragments in&#xD;
               the body, dental or hearing prostheses, insulin pump, patient wearing an IUD,&#xD;
               claustrophobic patient&#xD;
  &#xD;
            5. Patient unable to maintain decubitus position for the duration of the MRI (= 50&#xD;
               minutes)&#xD;
  &#xD;
          Inclusion criteria for healthy volunteers:&#xD;
  &#xD;
            1. Subject 18 years of age or older&#xD;
  &#xD;
            2. Subject free of general illness, psychiatric disorders, and infectious, inflammatory,&#xD;
               tumor, vascular, degenerative, or traumatic pathology of the central nervous system as&#xD;
               determined during the medical interview.&#xD;
  &#xD;
            3. Subject who has signed an informed consent ;&#xD;
  &#xD;
            4. Subjects who are beneficiaries of or affiliated with a social security plan&#xD;
  &#xD;
          Exclusion criteria for healthy volunteers:&#xD;
  &#xD;
            1. Protected subject: pregnant or breastfeeding woman, adult under guardianship or&#xD;
               curatorship&#xD;
  &#xD;
            2. Subjects presenting a contraindication to the realization of a 7T MRI: patient with a&#xD;
               pacemaker, neurosurgical clips, artificial heart valve, surgical material or metal&#xD;
               fragments in the body, dental or auditory prostheses, insulin pump, patient with an&#xD;
               IUD, claustrophobic patient&#xD;
  &#xD;
            3. Subject unable to maintain a decubitus position for the duration of the MRI (= 50&#xD;
               minutes)&#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>François Crémieux</last_name>
      <role>Study Director</role>
      <affiliation>AP-HM</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Isabelle LAMBERT, MD, PhD</last_name>
      <phone>04 91 38 47 76</phone>
      <phone_ext>33</phone_ext>
      <email>isabelle.lambert@ap-hm.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil</name>
        <address>
          <city>Marseille</city>
          <zip>13005</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Isabell Lambert, MD,PhD</last_name>
        <phone>04 91 38 47 76</phone>
        <phone_ext>33</phone_ext>
        <email>isabelle.lambert@ap-hm.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>narcolepsy</keyword>
    <keyword>7T MRI</keyword>
    <keyword>hypothalamus</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Narcolepsy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967832
  org study id: RCAPHM22_0378
  secondary id: ID-RCB
  nct id: NCT05967832
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is part of the research on type 1 narcolepsy, a neurological pathology affecting
        mostly young subjects. The only biomarker currently available is the hypocretin assay, which
        shows a level below 110 pg/mL. However, the interpretation of this biomarker has limitations:
        the test is not widely available and it is rarely performed by practitioners. Even when
        performed, the interpretation of the level may not be consistent with the phenotype
        compatible with type 1 narcolepsy.
  
        This study therefore aims to develop new tools to reduce the diagnostic delay. This would be
        the first study with 7T MRI that could achieve a level of spatial resolution sufficient to
        highlight volume changes in small brain structures such as the lateral hypothalamus whose
        narcolepsy-induced changes are not detected by lower resolution MRI.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Hypothalamic morphological difference
  time frame: Month 0
  description: Significant structural size difference between right and left lateral hypothalamus
  measure: Microstructural abnormalities other than volume differences
  time frame: Month 0
  description: Significant difference in Diffusion and T2* values in the lateral hypothalamus
  measure: Structural changes in hypothalamic nuclei other than the lateral hypothalamus
  time frame: Month 0
  description: Significant difference in volumes and T1 values in other regions of the posterior hypothalamus
  arm group label: Patients with type 1 narcolepsy
  arm group type: Experimental
  description: Patients with type 1 narcolepsy
  arm group label: Healthy volunteers
  arm group type: Active Comparator
  intervention type: Other
  intervention name: 7T MRI
  description: Patients and healthy volunteers will have a 7T MRI
  arm group label: Healthy volunteers
  arm group label: Patients with type 1 narcolepsy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: François Crémieux
  role: Study Director
  affiliation: AP-HM
  last name: Isabelle LAMBERT, MD, PhD
  phone: 04 91 38 47 76
  phone ext: 33
  email: isabelle.lambert@ap-hm.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Narcolepsy
  sharing ipd: Undecided