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/NCT06005038</url>
    </required_header>
    <id_info>
      <org_study_id>71235</org_study_id>
      <nct_id>NCT06005038</nct_id>
    </id_info>
    <brief_title>CogT pSOPT Intervention Study</brief_title>
    <official_title>Personalized Engine for Speed of Information Processing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</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>
        (JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727)&#xD;
        was focused on intervention development; R33 stage will focus on pilot testing the effect of&#xD;
        the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be&#xD;
        considered a NIH defined clinical trial)&#xD;
  &#xD;
        The purpose is to develop and test the effect of a &quot;personalized&quot; computer-based cognitive&#xD;
        training program. The personalized program tailors the difficulty of the training tasks using&#xD;
        a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a&#xD;
        personalization will ensure that the participant can perform at his/her ideal training&#xD;
        capacity. Participants will be randomized into one of 2 groups and each group will play a&#xD;
        different version of computerized training game and have ECG collected to allow subject&#xD;
        blinding.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
    <phase>Phase 1</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>composite cognitive measure</measure>
      <time_frame>Baseline, Week 7, and 3-month</time_frame>
      <description>a composite score of episodic memory and executive function. Episodic memory will be assessed using the Rey Auditory Verbal Learning and Brief Visuospatial Memory tests. We will use alternative forms of the tests to reduce practice effects.The Z-transform scores across all assessment points within each test will be developed first to derive 2 composite scores (learning and delayed recall). Executive function will be measured using the EXAMINER, a computerized test package designed for RCTs. It includes 8 tests and calculates 4 sub-domain composite scores on working memory (Dot counting and N-back), inhibition (Flanker, Continuous Performance Test, and Anti-saccades), cognitive control (Dimensional Set Shifting), and Fluency (Phonemic Fluency and Category Fluency), and an overall composite score for executive function. A composite score synthesizing EXAMINER composite score, learning, and delayed recall will be created; higher indicates better performance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>central autonomic network (CAN) functional integrity</measure>
      <time_frame>Baseline, Week 7, and 3-month</time_frame>
      <description>BOLD during resting-state will be collected using a gradient echo-planar imaging sequence. The functional scans will be acquired using simultaneous multi-slice at sub-second TRs. An in-scanner camera will be used to ensure compliance. Identification of CAN involved networks for the study: We will utilize a functional network template along with 268 ROIs described previously. In this functional template, we will focus on CAN related networks, including SN, DMN, subcortical network, and frontoparietal networks, along with ACC subregions. The data will be analyzed using the FSL software packages. fMRI preprocessing will consist of motion correction, slice-timing correction, normalization, and Gaussian spatial smoothing (FWHM 8mm). To calculate resting-state and task-related fMRI, the correlation coefficient between ROI pair across the time course will be Fisher Z-transformed and averaged to derive summary scores for network strength; higher indicates stronger network strength.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Subjective Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>pSOPT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>personalized cognitive training with a close-loop parasympathetic nervous system monitored component</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MLA</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>computerized mental leisure activities</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>pSOPT</intervention_name>
      <description>computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)</description>
      <arm_group_label>pSOPT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MLA</intervention_name>
      <description>computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.</description>
      <arm_group_label>MLA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. criteria related to defining &quot;mild cognitive impairment&quot;: a. Presence of memory&#xD;
               complaint; b. Rey Auditory Verbal Learning Test delayed recall (for memory) &lt; 59% of&#xD;
               age-adjusted norm; c. Montreal Cognitive Assessment (for global cognition) ranged 18&#xD;
               and 27; d. Functional Assessment Questionnaire (for activities of daily living) &lt; 20.&#xD;
  &#xD;
            2. intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).&#xD;
  &#xD;
            3. if a participant is on AD medication (i.e., memantine, cholinesterase inhibitors,&#xD;
               amyloid antibodies), antidepressants, anxiolytics, or vascular risk or diseases&#xD;
               related medications (e.g., beta-blocker), the dose should be stable for 3 months prior&#xD;
               to recruitment.&#xD;
  &#xD;
            4. age 60+,&#xD;
  &#xD;
            5. read and understand English&#xD;
  &#xD;
            6. adequate visual and hearing acuity for testing by self-report,&#xD;
  &#xD;
            7. community-dwelling (including independent living).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. current enrollment in another cognitive improvement study;&#xD;
  &#xD;
            2. uncontrollable major depression;&#xD;
  &#xD;
            3. major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure,&#xD;
               pacemaker, prior myocardial infarction);&#xD;
  &#xD;
            4. having an active legal guardian (indicating impaired capacity for decision making);&#xD;
  &#xD;
            5. currently pregnant&#xD;
  &#xD;
            6. 3T MRI contraindication&#xD;
  &#xD;
            7. Neurological conditions: Neurodegenerative disease diagnosis such as Parkinson's,&#xD;
               Alzheimers, dementia, multiple sclerosis. Of note, other neurological&#xD;
               conditions/injury such as stroke, seizures, traumatic brain injury, will be evaluated&#xD;
               for inclusion/exclusion on a case-by-case basis based on event recency, severity, and&#xD;
               recovery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Feng Lin</last_name>
      <phone>6082156005</phone>
      <email>vankee_lin@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarah Therrien</last_name>
      <phone>(650) 497-8434</phone>
      <email>cogtlab_stanford@stanford.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Feng Lin</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</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/NCT06005038
  org study id: 71235
  nct id: NCT06005038
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  (JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727)
        was focused on intervention development; R33 stage will focus on pilot testing the effect of
        the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be
        considered a NIH defined clinical trial)
  
        The purpose is to develop and test the effect of a "personalized" computer-based cognitive
        training program. The personalized program tailors the difficulty of the training tasks using
        a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a
        personalization will ensure that the participant can perform at his/her ideal training
        capacity. Participants will be randomized into one of 2 groups and each group will play a
        different version of computerized training game and have ECG collected to allow subject
        blinding.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: composite cognitive measure
  time frame: Baseline, Week 7, and 3-month
  description: a composite score of episodic memory and executive function. Episodic memory will be assessed using the Rey Auditory Verbal Learning and Brief Visuospatial Memory tests. We will use alternative forms of the tests to reduce practice effects.The Z-transform scores across all assessment points within each test will be developed first to derive 2 composite scores (learning and delayed recall). Executive function will be measured using the EXAMINER, a computerized test package designed for RCTs. It includes 8 tests and calculates 4 sub-domain composite scores on working memory (Dot counting and N-back), inhibition (Flanker, Continuous Performance Test, and Anti-saccades), cognitive control (Dimensional Set Shifting), and Fluency (Phonemic Fluency and Category Fluency), and an overall composite score for executive function. A composite score synthesizing EXAMINER composite score, learning, and delayed recall will be created; higher indicates better performance.
  measure: central autonomic network (CAN) functional integrity
  time frame: Baseline, Week 7, and 3-month
  description: BOLD during resting-state will be collected using a gradient echo-planar imaging sequence. The functional scans will be acquired using simultaneous multi-slice at sub-second TRs. An in-scanner camera will be used to ensure compliance. Identification of CAN involved networks for the study: We will utilize a functional network template along with 268 ROIs described previously. In this functional template, we will focus on CAN related networks, including SN, DMN, subcortical network, and frontoparietal networks, along with ACC subregions. The data will be analyzed using the FSL software packages. fMRI preprocessing will consist of motion correction, slice-timing correction, normalization, and Gaussian spatial smoothing (FWHM 8mm). To calculate resting-state and task-related fMRI, the correlation coefficient between ROI pair across the time course will be Fisher Z-transformed and averaged to derive summary scores for network strength; higher indicates stronger network strength.
  arm group label: pSOPT
  arm group type: Experimental
  description: personalized cognitive training with a close-loop parasympathetic nervous system monitored component
  arm group label: MLA
  arm group type: Placebo Comparator
  description: computerized mental leisure activities
  intervention type: Behavioral
  intervention name: pSOPT
  description: computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
  arm group label: pSOPT
  intervention type: Behavioral
  intervention name: MLA
  description: computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.
  arm group label: MLA
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Feng Lin
  phone: 6082156005
  email: vankee_lin@stanford.edu
  last name: Sarah Therrien
  phone: (650) 497-8434
  email: cogtlab_stanford@stanford.edu
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Feng Lin
  investigator title: Clinical Professor
  mesh term: Cognitive Dysfunction
  sharing ipd: No