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/NCT06041659</url>
    </required_header>
    <id_info>
      <org_study_id>2023022</org_study_id>
      <nct_id>NCT06041659</nct_id>
    </id_info>
    <brief_title>Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia</brief_title>
    <official_title>Functional Magnetic Resonance-Based Observations of Brain Networks and Cerebrovascular Reactivity in Patients With Moyamoya Disease Under Anesthetic Sedation, A Prospective Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Tiantan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Tiantan Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Moyamoya disease is characterized by progressive stenosis of the genesis of the distal&#xD;
        internal carotid arteries bilaterally and progressive generation of compensatory pathological&#xD;
        vascular networks at the basis cranii, and these pathological vasculature has poor vascular&#xD;
        reactivity. Perioperative circulatory management of patients with smoky vessels to ensure&#xD;
        perfusion of brain tissue and integrity of brain network during surgery to minimize&#xD;
        postoperative impairment of neurological functions, including motor, sensory, emotional and&#xD;
        cognitive functions, is the key point of perioperative circulatory management of moyamoya&#xD;
        disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various&#xD;
        cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network&#xD;
        connectivity. The purpose of this study is to observe the changes in cerebral blood flow,&#xD;
        cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network&#xD;
        connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas&#xD;
        under anesthesia to provide a basis for exploring anesthesia management to improve cognitive&#xD;
        function and cerebral network connectivity in these patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Changes of brain functional network</measure>
      <time_frame>Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative delirium</measure>
      <time_frame>Day1-5 after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Electroencephalogram changes</measure>
      <time_frame>Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Moyamoya Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          We plan to recruit consecutive patients with moyamoya disease who are to undergo direct or&#xD;
          indirect revascularization surgery from August 2023 to December 2025 at Beijing Tiantan&#xD;
          Hospital of Capital Medical University.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with ischemic moyamoya disease scheduled for direct or indirect intracranial&#xD;
               and extracranial revascularization surgery&#xD;
  &#xD;
            -  Age between 18-65 years&#xD;
  &#xD;
            -  Obtain written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to&#xD;
               understand and cooperate with the examination&#xD;
  &#xD;
            -  Preoperative cranial imaging suggesting cerebral infarction lesion diameter &gt;15mm&#xD;
  &#xD;
            -  Patients allergic to anesthetic drugs&#xD;
  &#xD;
            -  Metal implants in the body&#xD;
  &#xD;
            -  Undergoing other experimental drug or instrumentation trials&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shu Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Tiantan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shu Li</last_name>
      <phone>8613699223065</phone>
      <email>lishu@bjtth.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Tiantan Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100070</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
      <investigator_full_name>Yuming Peng</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Moyamoya Disease</keyword>
    <keyword>Cerebral Network</keyword>
    <keyword>Cognitive Function</keyword>
    <keyword>Anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Moyamoya Disease</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/NCT06041659
  org study id: 2023022
  nct id: NCT06041659
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Moyamoya disease is characterized by progressive stenosis of the genesis of the distal
        internal carotid arteries bilaterally and progressive generation of compensatory pathological
        vascular networks at the basis cranii, and these pathological vasculature has poor vascular
        reactivity. Perioperative circulatory management of patients with smoky vessels to ensure
        perfusion of brain tissue and integrity of brain network during surgery to minimize
        postoperative impairment of neurological functions, including motor, sensory, emotional and
        cognitive functions, is the key point of perioperative circulatory management of moyamoya
        disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various
        cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network
        connectivity. The purpose of this study is to observe the changes in cerebral blood flow,
        cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network
        connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas
        under anesthesia to provide a basis for exploring anesthesia management to improve cognitive
        function and cerebral network connectivity in these patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Changes of brain functional network
  time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
  measure: Postoperative delirium
  time frame: Day1-5 after surgery
  measure: Electroencephalogram changes
  time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Shu Li
  role: Principal Investigator
  affiliation: Beijing Tiantan Hospital
  last name: Shu Li
  phone: 8613699223065
  email: lishu@bjtth.org
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Beijing Tiantan Hospital
  investigator full name: Yuming Peng
  investigator title: Clinical Professor
  mesh term: Moyamoya Disease
  sharing ipd: Undecided