<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/NCT03801382</url>
  </required_header>
  <id_info>
    <org_study_id>ICBE-2-28674</org_study_id>
    <nct_id>NCT03801382</nct_id>
  </id_info>
  <brief_title>Psychometric Properties of IntelliSpace Cognition</brief_title>
  <official_title>Study to Establish the Psychometric Properties of the Digital Cognitive Tests on the Philips IntelliSpace Cognition Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Electronics Nederland B.V. acting through Philips CTO organization</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research America Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qserve</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Factory CRO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Philips Electronics Nederland B.V. acting through Philips CTO organization</source>
  <oversight_info>
    <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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to validate the tests that are on the IntelliSpace Cognition platform and to&#xD;
      establish normative data for these tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">August 26, 2019</completion_date>
  <primary_completion_date type="Actual">August 26, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scores Digital (ISC) Tests</measure>
    <time_frame>1.5 hours</time_frame>
    <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores Digital (ISC) Tests</measure>
    <time_frame>1.5 hours</time_frame>
    <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).&#xD;
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores From Paper Tests</measure>
    <time_frame>1.5 hours</time_frame>
    <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores From Paper Tests</measure>
    <time_frame>1.5 hours</time_frame>
    <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).&#xD;
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Cognitive Functioning of Healthy Individuals</condition>
  <arm_group>
    <arm_group_label>Digital / Paper</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paper / Digital</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Digital / Digital</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paper / Paper</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Digital</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IntelliSpace Cognition (ISC)</intervention_name>
    <description>Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
    <arm_group_label>Digital</arm_group_label>
    <arm_group_label>Digital / Digital</arm_group_label>
    <arm_group_label>Digital / Paper</arm_group_label>
    <arm_group_label>Paper / Digital</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Paper-Pencil Tests</intervention_name>
    <description>The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
    <arm_group_label>Digital / Paper</arm_group_label>
    <arm_group_label>Paper / Digital</arm_group_label>
    <arm_group_label>Paper / Paper</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Examinee's primary language (language most often spoken) must be English.&#xD;
&#xD;
          -  If examinee has vision impairment or hearing loss, must be corrected to normal.&#xD;
&#xD;
          -  Must have normal fine and gross motor ability&#xD;
&#xD;
          -  Must have use of fingers, hands, and arms to be able to use a pencil to write symbols.&#xD;
&#xD;
          -  Must be able to understand subtest instructions and participate fully in testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of current cognitive impairment.&#xD;
&#xD;
          -  Disruptive behavior or insufficient compliance with testing to ensure a valid&#xD;
             assessment.&#xD;
&#xD;
          -  Examinee must not be currently admitted to a hospital, assisted living, nursing home&#xD;
             or a psychiatric facility.&#xD;
&#xD;
          -  Examinee must not be diagnosed with a neurological disorder or disease (e.g.,&#xD;
             Parkinson's, brain tumor, stroke, TBI, epilepsy [if # seizures ≤ 2 and not receiving&#xD;
             ongoing treatment for seizures, and not currently seeking medical evaluation or&#xD;
             attention related to seizures, examinee can be accepted], encephalitis, dementia,&#xD;
             language disorder (expressive or mixed receptive/expressive excluded; articulation&#xD;
             disorder is ok), learning disorder.&#xD;
&#xD;
          -  Must not have been unconscious related to traumatic brain injury or &quot;medical&#xD;
             condition&quot; &gt; 20 minutes (however, e.g., heat stroke, medication induced are ok) or any&#xD;
             head-injury resulting in an overnight hospital stay.&#xD;
&#xD;
          -  Any history of a medical event requiring resuscitation in which examinee was&#xD;
             non-responsive for &gt; 15 minutes.&#xD;
&#xD;
          -  Must not have current or recent functional change (ability to carry out usual duties&#xD;
             at work, in school, IADLs [driving, shopping, managing money], etc.) due to cognitive&#xD;
             change.&#xD;
&#xD;
          -  Examinee must not be receiving chemotherapy treatment, or have received chemotherapy&#xD;
             treatment in the past 2 months.&#xD;
&#xD;
          -  Examinee must not have a history of ECT or radiation to the CNS.&#xD;
&#xD;
          -  Examinee must not be (currently or in the past) diagnosed with a psychotic disorder,&#xD;
             or currently diagnosed with a mood disorder (however, Major Depressive Disorder in&#xD;
             remission or with no current episode, and Dysthymic and Adjustment Disorders, are&#xD;
             acceptable) or an anxiety disorder with symptoms significant enough to interfere with&#xD;
             optimal test performance.&#xD;
&#xD;
          -  Autoimmune disorder (e.g., LUPUS, Multiple Sclerosis)&#xD;
&#xD;
          -  Examinee must not be currently diagnosed with substance abuse or dependence, or have&#xD;
             carried any substance abuse or dependence diagnosis in the past year (&gt; 1 year in&#xD;
             remission diagnoses are ok). Long term alcohol abusers are excluded as well (e.g.,&#xD;
             abused substance for more than 10 years).&#xD;
&#xD;
          -  Any history of Autism Spectrum Disorder or Intellectual Disability.&#xD;
&#xD;
          -  The examinee must not be currently taking medication that might impact test&#xD;
             performance (e.g., anti-convulsants, antipsychotics, benzodiazepines,&#xD;
             psychostimulants, opiods, tricyclic antidepressants, some norepinephrine reuptake&#xD;
             inhibitors). Most antihypertensive medications and statins are acceptable.&#xD;
&#xD;
          -  If previously diagnosed with any physical condition or illness that might depress test&#xD;
             performance, illness must not interfere with normal cognitive functioning at work,&#xD;
             school, ADLs, etc. Diabetes, hypothyroidism, and hypertension are acceptable if&#xD;
             controlled.&#xD;
&#xD;
          -  Exclude primarily nonverbal or uncommunicative. Must not have a diagnosis of aphasia.&#xD;
&#xD;
          -  Examinees should not have received neuropsychological testing although previous MMSE&#xD;
             testing is allowed if more than 6 months prior&#xD;
&#xD;
          -  Examinee must not be seeking medical diagnostic procedures for cognitive difficulties&#xD;
             from a medical professional.&#xD;
&#xD;
          -  Non-valid health insurance in USA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research America Inc.</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>January 24, 2023</results_first_submitted>
  <results_first_submitted_qc>May 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2023</results_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive model</keyword>
  <keyword>cognitive assessment</keyword>
  <keyword>digital cognitive tests</keyword>
  <keyword>automated scoring</keyword>
  <keyword>algorithms</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03801382/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Digital / Paper</title>
          <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.&#xD;
Paper-Pencil Tests: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
        </group>
        <group group_id="P2">
          <title>Paper / Digital</title>
          <description>Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.&#xD;
Paper-Pencil Tests: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
        </group>
        <group group_id="P3">
          <title>Digital / Digital</title>
          <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
        </group>
        <group group_id="P4">
          <title>Paper / Paper</title>
          <description>Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.&#xD;
Paper-Pencil Tests: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
        </group>
        <group group_id="P5">
          <title>Digital</title>
          <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Digital / Paper</title>
          <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.&#xD;
Paper-Pencil Tests: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
        </group>
        <group group_id="B2">
          <title>Paper / Digital</title>
          <description>Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.&#xD;
Paper-Pencil Tests: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
        </group>
        <group group_id="B3">
          <title>Digital / Digital</title>
          <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
        </group>
        <group group_id="B4">
          <title>Paper / Paper</title>
          <description>Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.&#xD;
Paper-Pencil Tests: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.</description>
        </group>
        <group group_id="B5">
          <title>Digital</title>
          <description>Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A&#xD;
IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="99"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="53"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="148"/>
            <count group_id="B6" value="450"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.2" spread="7"/>
                    <measurement group_id="B2" value="66.3" spread="7.5"/>
                    <measurement group_id="B3" value="65.9" spread="7.4"/>
                    <measurement group_id="B4" value="65.7" spread="7.3"/>
                    <measurement group_id="B5" value="62" spread="8.9"/>
                    <measurement group_id="B6" value="64.9" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="79"/>
                    <measurement group_id="B6" value="238"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="69"/>
                    <measurement group_id="B6" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="134"/>
                    <measurement group_id="B6" value="410"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="148"/>
                    <measurement group_id="B6" value="450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MMSE</title>
          <description>Mini-Mental State Examination The MMSE has a scale that ranges from 0 to 30 with higher scores indicating a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.6" spread="1.9"/>
                    <measurement group_id="B2" value="27.6" spread="2.1"/>
                    <measurement group_id="B3" value="27.1" spread="1.9"/>
                    <measurement group_id="B4" value="27.9" spread="1.6"/>
                    <measurement group_id="B5" value="27.8" spread="1.7"/>
                    <measurement group_id="B6" value="27.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Scores Digital (ISC) Tests</title>
        <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
        <time_frame>1.5 hours</time_frame>
        <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Sample</title>
            <description>IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores Digital (ISC) Tests</title>
          <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
          <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rey Auditory Verbal Learning Test (score range 0-45, higher score indicates better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clock Test Drawing (on scale from 0-22, higher score indicates better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clock Test Copy (on scale from 0-22, higher score indicates better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey Osterrieth Complex Figure Test Copy (scale 0-36, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey Osterrieth Complex Figure Test Recall (scale 0-36, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Digit Span forward (number of items correct, range 0-12, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Digit Span backward (number of items correct, range 0-12, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Validity and test-retest reliability were explored</non_inferiority_desc>
            <p_value>&gt;.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.05</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>Validity and test-retest reliability were explored</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores Digital (ISC) Tests</title>
        <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
        <time_frame>1.5 hours</time_frame>
        <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Sample</title>
            <description>IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores Digital (ISC) Tests</title>
          <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
          <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trail Making Test A (in seconds)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trail Making Test B (in seconds)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.7" spread="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores Digital (ISC) Tests</title>
        <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).&#xD;
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)</description>
        <time_frame>1.5 hours</time_frame>
        <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Sample</title>
            <description>IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores Digital (ISC) Tests</title>
          <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).&#xD;
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)</description>
          <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
          <units>completion time/number correct words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".9" spread=".2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores Digital (ISC) Tests</title>
        <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
        <time_frame>1.5 hours</time_frame>
        <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Sample</title>
            <description>IntelliSpace Cognition (ISC): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores Digital (ISC) Tests</title>
          <description>Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
          <population>Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.</population>
          <units>number of words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Letter Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores From Paper Tests</title>
        <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
        <time_frame>1.5 hours</time_frame>
        <population>Descriptives</population>
        <group_list>
          <group group_id="O1">
            <title>Paper-pencil Group</title>
            <description>All groups combined that have received the paper-pencil cognitive tests. Only visit 1 performance is reported.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores From Paper Tests</title>
          <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
          <population>Descriptives</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rey Auditory Verbal Learning Test (range 0-45, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clock Test Drawing (range 0-12, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clock Test Copy (range 0-12, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread=".7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey Osterrieth Complex Figure Test Copy (range 0-36, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rey Osterrieth Complex Figure Test Recall (range 0-36, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Digit Span forward (number of correct items, range 0-12, higher indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Digit Span backward (number of correct items, range 0-12, higher indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores From Paper Tests</title>
        <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
        <time_frame>1.5 hours</time_frame>
        <population>Descriptives</population>
        <group_list>
          <group group_id="O1">
            <title>Paper-pencil Group</title>
            <description>All groups combined that have received the paper-pencil cognitive tests. Only visit 1 performance is reported.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores From Paper Tests</title>
          <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
          <population>Descriptives</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trail Making Test A (in seconds, higher indicating worse outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.9" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trail Making Test B (in seconds, higher indicating worse outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores From Paper Tests</title>
        <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).&#xD;
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)</description>
        <time_frame>1.5 hours</time_frame>
        <population>Descriptives</population>
        <group_list>
          <group group_id="O1">
            <title>Paper-pencil Group</title>
            <description>All groups combined that have received the paper-pencil cognitive tests. Only visit 1 performance is reported.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores From Paper Tests</title>
          <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).&#xD;
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)</description>
          <population>Descriptives</population>
          <units>completion time/number correct words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".8" spread=".3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scores From Paper Tests</title>
        <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
        <time_frame>1.5 hours</time_frame>
        <population>Descriptives</population>
        <group_list>
          <group group_id="O1">
            <title>Paper-pencil Group</title>
            <description>All groups combined that have received the paper-pencil cognitive tests. Only visit 1 performance is reported.</description>
          </group>
        </group_list>
        <measure>
          <title>Scores From Paper Tests</title>
          <description>Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).</description>
          <population>Descriptives</population>
          <units>number of words</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Letter Fluency Test (sum of correct words during 3 trials, higher indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For each participant, an assessment took approximately 1.5 hours. Any adverse events during this time period were recorded and reported within 24 hours.</time_frame>
      <desc>There were no serious adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Digital / Paper</title>
          <description>Participants in this arm first received the digital tests and then the paper tests.</description>
        </group>
        <group group_id="E2">
          <title>Paper / Digital</title>
          <description>Participants in this arm first received the paper tests and then the digital tests.</description>
        </group>
        <group group_id="E3">
          <title>Digital / Digital</title>
          <description>Participants in this arm received the digital tests during both assessments.</description>
        </group>
        <group group_id="E4">
          <title>Paper / Paper</title>
          <description>Participants in this arm received the paper tests during both assessments.</description>
        </group>
        <group group_id="E5">
          <title>Digital</title>
          <description>Participants in this arm received only one (digital) assessment.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical product lead</name_or_title>
      <organization>Philips Research</organization>
      <phone>+31646802217</phone>
      <email>daisy.van.minde@philips.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03801382
org study id: ICBE-2-28674
nct id: NCT03801382
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study aims to validate the tests that are on the IntelliSpace Cognition platform and to
      establish normative data for these tests.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Scores Digital (ISC) Tests
time frame: 1.5 hours
description: Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).
measure: Scores Digital (ISC) Tests
time frame: 1.5 hours
description: Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)
measure: Scores From Paper Tests
time frame: 1.5 hours
description: Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).
measure: Scores From Paper Tests
time frame: 1.5 hours
description: Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).
Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)
arm group label: Digital / Paper
arm group type: Other
description: Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
arm group label: Paper / Digital
arm group type: Other
description: Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.
arm group label: Digital / Digital
arm group type: Other
description: Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.
arm group label: Paper / Paper
arm group type: Other
description: Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
arm group label: Digital
arm group type: Other
description: Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A
intervention type: Device
intervention name: IntelliSpace Cognition (ISC)
description: Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.
arm group label: Digital
arm group label: Digital / Digital
arm group label: Digital / Paper
arm group label: Paper / Digital
intervention type: Diagnostic Test
intervention name: Paper-Pencil Tests
description: The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.
arm group label: Digital / Paper
arm group label: Paper / Digital
arm group label: Paper / Paper
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 