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/NCT05967390</url>
    </required_header>
    <id_info>
      <org_study_id>2018.077</org_study_id>
      <secondary_id>2018.077</secondary_id>
      <nct_id>NCT05967390</nct_id>
    </id_info>
    <brief_title>Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE)</brief_title>
    <acronym>LANDSCAPE</acronym>
    <official_title>Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE): A Project of MRI-informed Computational Head Model</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has&#xD;
        been highlighted in the guidelines of non-invasive brain stimulation. However, in the context&#xD;
        of age-related brain changes, the region-specific SCD and its impact on stimulation-induced&#xD;
        electric field in different types of neurodegenerative diseases remain unclear.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: This study aimed to investigate the region-specific SCD and its relationship with&#xD;
        morphometric features and cognitive function in age- and disease-specific populations.&#xD;
        Methods: The SCD and cortical thickness (CT) of left primary motor cortex (M1) and&#xD;
        dorsolateral prefrontal cortex (DLPFC) were measured in cognitively normal adults and&#xD;
        dementia patients. CT-adjusted SCD was used to control the influence of CT on SCD. Head model&#xD;
        was developed to simulate the impact of SCD on the electric field induced by transcranial&#xD;
        electrical stimulation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">June 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 14, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Scalp-to-cortex distance will be measured using geometric brain model</measure>
      <time_frame>Baseline</time_frame>
      <description>Scalp-to-cortex distance (SCD), as a geometric feature, will measured in the Brainsight TMS neuronavigation system.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">488</enrollment>
    <condition>Aging</condition>
    <condition>Dementia Alzheimers</condition>
    <condition>Parkinson Disease</condition>
    <condition>Dementia Frontotemporal</condition>
    <condition>Depression in Old Age</condition>
    <arm_group>
      <arm_group_label>Neurocognitive disorder (NCD)</arm_group_label>
      <description>The NCD patients are defined with a chronological age over 60 years and a Montreal Cognitive Assessment (MoCA) total score between 22 and 26.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
      <description>One time for each day, lasting for three weeks.</description>
      <arm_group_label>Neurocognitive disorder (NCD)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy normal ageing adults and adults with neurocognitive disorders&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Right-handed as assessed by the Edinburgh Inventory&#xD;
  &#xD;
            -  Able to attend TMS interventions&#xD;
  &#xD;
            -  Consent&#xD;
  &#xD;
            -  Independent in daily life activities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncorrected visual or auditive deficits not allowing the realization of the test&#xD;
  &#xD;
            -  Evolutive disease (such as cancer)&#xD;
  &#xD;
            -  Neurological or psychiatric antecedent&#xD;
  &#xD;
            -  Counter-indication to MRI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hanna LU, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hanna LU, PhD</last_name>
      <phone>28314305</phone>
      <phone_ext>852</phone_ext>
      <email>hannalu@cuhk.edu.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shu Yang</last_name>
      <phone>28314305</phone>
      <phone_ext>852</phone_ext>
      <email>nataliesyang@cuhk.edu.hk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tai Po Hospital</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Candy Wong</last_name>
        <phone>85226076063</phone>
        <email>candy.wong@cuhk.edu.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>LU Hanna</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Aging</keyword>
    <keyword>Scalp-to-cortex distance</keyword>
    <keyword>Transcranial brain stimulation</keyword>
    <keyword>Parkinson disease</keyword>
    <keyword>Simulation</keyword>
    <keyword>Predictor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Aphasia, Primary Progressive</mesh_term>
      <mesh_term>Pick Disease of the Brain</mesh_term>
      <mesh_term>Frontotemporal Dementia</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/NCT05967390
  org study id: 2018.077
  secondary id: 2018.077
  nct id: NCT05967390
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has
        been highlighted in the guidelines of non-invasive brain stimulation. However, in the context
        of age-related brain changes, the region-specific SCD and its impact on stimulation-induced
        electric field in different types of neurodegenerative diseases remain unclear.
  Objective: This study aimed to investigate the region-specific SCD and its relationship with
        morphometric features and cognitive function in age- and disease-specific populations.
        Methods: The SCD and cortical thickness (CT) of left primary motor cortex (M1) and
        dorsolateral prefrontal cortex (DLPFC) were measured in cognitively normal adults and
        dementia patients. CT-adjusted SCD was used to control the influence of CT on SCD. Head model
        was developed to simulate the impact of SCD on the electric field induced by transcranial
        electrical stimulation.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Scalp-to-cortex distance will be measured using geometric brain model
  time frame: Baseline
  description: Scalp-to-cortex distance (SCD), as a geometric feature, will measured in the Brainsight TMS neuronavigation system.
  arm group label: Neurocognitive disorder (NCD)
  description: The NCD patients are defined with a chronological age over 60 years and a Montreal Cognitive Assessment (MoCA) total score between 22 and 26.
  intervention type: Device
  intervention name: Transcranial Magnetic Stimulation
  description: One time for each day, lasting for three weeks.
  arm group label: Neurocognitive disorder (NCD)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 95 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hanna LU, PhD
  role: Principal Investigator
  affiliation: Chinese University of Hong Kong
  last name: Hanna LU, PhD
  phone: 28314305
  phone ext: 852
  email: hannalu@cuhk.edu.hk
  last name: Shu Yang
  phone: 28314305
  phone ext: 852
  email: nataliesyang@cuhk.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: LU Hanna
  investigator title: Assistant Professor
  mesh term: Parkinson Disease
  mesh term: Dementia
  mesh term: Alzheimer Disease
  mesh term: Aphasia, Primary Progressive
  mesh term: Pick Disease of the Brain
  mesh term: Frontotemporal Dementia
  sharing ipd: Undecided