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/NCT05978830</url>
    </required_header>
    <id_info>
      <org_study_id>Diagnosis and prognosis of AD</org_study_id>
      <nct_id>NCT05978830</nct_id>
    </id_info>
    <brief_title>Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.</brief_title>
    <official_title>The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Zhejiang University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Developing and validating an early digitalized recognition device and multimodal warning&#xD;
        model for Alzheimer's disease, and establishing a precision transcranial ultrasound&#xD;
        stimulation intervention system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Establishment of early digitalized recognition devices and multimodal warning models for&#xD;
             AD: Participants undergo clinical assessments, and if they meet the inclusion criteria,&#xD;
             their gender, age, MMSE, MoCA, CDR, GDS scores, as well as EEG ERP and MR data are&#xD;
             collected. Eye-tracking analysis based on human-computer interaction perception&#xD;
             technology, limb movement detection, and laser radar depth sensor fusion cognitive&#xD;
             assessment are also performed simultaneously. After enrollment, follow-up assessments&#xD;
             using scales (MMSE, MoCA, CDR, GDS, ADAS-cog, etc.) are conducted every six months, and&#xD;
             EEG ERP and MR data are collected annually.&#xD;
  &#xD;
          2. Construction of a precision transcranial ultrasound stimulation intervention system:&#xD;
             Participants were randomly divided into true stimulation group and false stimulation&#xD;
             group: true/false stimulation for 2 weeks, washout for 2 weeks, false/true stimulation&#xD;
             for 2 weeks. After treatment, behavioral scale assessment, EEG ERP and multimodal MRI&#xD;
             were performed to evaluate the therapeutic effect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Cognitive assessment was performed by neuropsychological professionals before and after each treatment, and treatment was performed with real and fake stimuli Multimodal MRI was performed again 2 days later. (1) Subjects in one group received Active Transcranial ultrasound stimulation for 2 weeks ; The other group received Sham Transcranial ultrasound stimulation for 2 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>The study is double-blinded, meaning both participant and Investigator are unaware of the treatment received by the patients.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Power spectrum</measure>
      <time_frame>6 months</time_frame>
      <description>The investigators collected EEG data of participants in resting state and listening to music and the absolute power spectral density values (alpha,beta,theta,delta bands dB/Hz) will be calculated using spectral analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of microstate</measure>
      <time_frame>6 months</time_frame>
      <description>The investigators refined the microstate method to accurately estimate topographical differences. The calculations were performed for measures of duration (ms). The duration of each microstate were utilized to predict disease classification and prognosis evaluation for patients with Alzheimer's disease.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of microstate</measure>
      <time_frame>6 months</time_frame>
      <description>The investigators refined the microstate analysis. The calculations were performed for measures of occurrence (times per minute). The occurrence of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>6 months</time_frame>
      <description>MMSE includes a series of questions and tasks to assess the individual's memory, attention, calculation, language, spatial, and executive functions. The test items include recalling instructions, reproducing patterns, performing mathematical calculations, naming objects, writing sentences, etc. Each item has different scoring criteria, and scores are assigned based on the participant's responses and performance. The total score is 30, with higher scores indicating better cognitive functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>6 months</time_frame>
      <description>MoCA is a standardized assessment tool used to evaluate cognitive function, particularly for early cognitive impairment and mild cognitive impairment. It consists of a series of questions and tasks that cover areas such as memory, attention, executive functions, language, and spatial abilities. Test items include naming animals, drawing a clock, recalling a sequence, task guidance, etc., and each item is assigned a different score. The score range is from 0 to 30, with higher scores indicating better cognitive function.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Alzheimer's Disease</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial ultrasound stimulation</intervention_name>
      <description>In each active/sham-ultrasound stimulation experiment, subjects first underwent two baseline motor evoked potential (MEP) tests, with an interval of 15 minutes between the two baseline tests. After 15 minutes of true/pseudo-transcranial ultrasound stimulation, subjects immediately underwent a MEP test, and then 15 minutes later, subjects underwent another MEP test. The MEP was tested again 15 minutes later.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with MCI / AD&#xD;
  &#xD;
            2. Between the ages of 55 and 80&#xD;
  &#xD;
            3. No history of mental illness such as schizophrenia, severe anxiety and depression&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Consistent with Parkinson's disease, frontotemporal dementia, dementia with lewy&#xD;
               bodies Or Huntington's disease diagnostic criteria&#xD;
  &#xD;
            2. Dementia due to other causes (e.g. cerebrovascular disease, central nervous system&#xD;
               trauma, tumors, infections, Metabolic diseases, normal stress hydrocephalus, folic&#xD;
               acid or vitamin B12 deficiency, hypothyroidism, etc.)&#xD;
  &#xD;
            3. Have aphasia,Disorders that affect cognitive assessment, such as disorders of&#xD;
               consciousness&#xD;
  &#xD;
            4. Have a history of epilepsy or take antiepileptic drugs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>benyan luo, Pro</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yi Ling, Dr</last_name>
      <phone>15168236137</phone>
      <email>12118458@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fangping He</last_name>
      <phone>13819114225</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yi Ling</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yi Ling</last_name>
        <phone>15168236137</phone>
        <email>lywenzhoumc@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>EEG</keyword>
    <keyword>MRI</keyword>
    <keyword>Digital intelligence equipment</keyword>
    <keyword>Machine learning</keyword>
    <keyword>microstate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05978830
  org study id: Diagnosis and prognosis of AD
  nct id: NCT05978830
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Developing and validating an early digitalized recognition device and multimodal warning
        model for Alzheimer's disease, and establishing a precision transcranial ultrasound
        stimulation intervention system.
  1. Establishment of early digitalized recognition devices and multimodal warning models for
             AD: Participants undergo clinical assessments, and if they meet the inclusion criteria,
             their gender, age, MMSE, MoCA, CDR, GDS scores, as well as EEG ERP and MR data are
             collected. Eye-tracking analysis based on human-computer interaction perception
             technology, limb movement detection, and laser radar depth sensor fusion cognitive
             assessment are also performed simultaneously. After enrollment, follow-up assessments
             using scales (MMSE, MoCA, CDR, GDS, ADAS-cog, etc.) are conducted every six months, and
             EEG ERP and MR data are collected annually.
  
          2. Construction of a precision transcranial ultrasound stimulation intervention system:
             Participants were randomly divided into true stimulation group and false stimulation
             group: true/false stimulation for 2 weeks, washout for 2 weeks, false/true stimulation
             for 2 weeks. After treatment, behavioral scale assessment, EEG ERP and multimodal MRI
             were performed to evaluate the therapeutic effect.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Cognitive assessment was performed by neuropsychological professionals before and after each treatment, and treatment was performed with real and fake stimuli Multimodal MRI was performed again 2 days later. (1) Subjects in one group received Active Transcranial ultrasound stimulation for 2 weeks ; The other group received Sham Transcranial ultrasound stimulation for 2 weeks.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: The study is double-blinded, meaning both participant and Investigator are unaware of the treatment received by the patients.
  measure: Power spectrum
  time frame: 6 months
  description: The investigators collected EEG data of participants in resting state and listening to music and the absolute power spectral density values (alpha,beta,theta,delta bands dB/Hz) will be calculated using spectral analysis.
  measure: Duration of microstate
  time frame: 6 months
  description: The investigators refined the microstate method to accurately estimate topographical differences. The calculations were performed for measures of duration (ms). The duration of each microstate were utilized to predict disease classification and prognosis evaluation for patients with Alzheimer's disease.
  measure: Occurrence of microstate
  time frame: 6 months
  description: The investigators refined the microstate analysis. The calculations were performed for measures of occurrence (times per minute). The occurrence of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.
  measure: Mini-Mental State Examination (MMSE)
  time frame: 6 months
  description: MMSE includes a series of questions and tasks to assess the individual's memory, attention, calculation, language, spatial, and executive functions. The test items include recalling instructions, reproducing patterns, performing mathematical calculations, naming objects, writing sentences, etc. Each item has different scoring criteria, and scores are assigned based on the participant's responses and performance. The total score is 30, with higher scores indicating better cognitive functioning.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: 6 months
  description: MoCA is a standardized assessment tool used to evaluate cognitive function, particularly for early cognitive impairment and mild cognitive impairment. It consists of a series of questions and tasks that cover areas such as memory, attention, executive functions, language, and spatial abilities. Test items include naming animals, drawing a clock, recalling a sequence, task guidance, etc., and each item is assigned a different score. The score range is from 0 to 30, with higher scores indicating better cognitive function.
  arm group label: Group 1
  arm group type: Experimental
  description: The group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks
  arm group label: Group 2
  arm group type: Sham Comparator
  description: The group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks
  intervention type: Device
  intervention name: Transcranial ultrasound stimulation
  description: In each active/sham-ultrasound stimulation experiment, subjects first underwent two baseline motor evoked potential (MEP) tests, with an interval of 15 minutes between the two baseline tests. After 15 minutes of true/pseudo-transcranial ultrasound stimulation, subjects immediately underwent a MEP test, and then 15 minutes later, subjects underwent another MEP test. The MEP was tested again 15 minutes later.
  arm group label: Group 1
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: benyan luo, Pro
  role: Study Chair
  affiliation: Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University
  last name: Yi Ling, Dr
  phone: 15168236137
  email: 12118458@zju.edu.cn
  last name: Fangping He
  phone: 13819114225
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  sharing ipd: No