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Trial record 1 of 1 for:    NCT03801382
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Psychometric Properties of IntelliSpace Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801382
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Research America Inc
Qserve
Factory CRO
Information provided by (Responsible Party):
Philips Electronics Nederland B.V. acting through Philips CTO organization

Brief Summary:
This study aims to validate the tests that are on the IntelliSpace Cognition platform and to establish normative data for these tests.

Condition or disease Intervention/treatment Phase
Cognitive Functioning of Healthy Individuals Device: IntelliSpace Cognition (ISC) Diagnostic Test: Paper-Pencil Tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 549 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study to Establish the Psychometric Properties of the Digital Cognitive Tests on the Philips IntelliSpace Cognition Platform
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : August 26, 2019
Actual Study Completion Date : August 26, 2019

Arm Intervention/treatment
Digital / Paper
Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
Device: 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.

Diagnostic Test: 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.

Paper / Digital
Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.
Device: 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.

Diagnostic Test: 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.

Digital / Digital
Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.
Device: 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.

Paper / Paper
Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
Diagnostic Test: 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.

Digital
Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A
Device: 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.




Primary Outcome Measures :
  1. Scores digital (ISC) tests [ Time Frame: 1.5 hours ]
    Scores retrieved from all cognitive tests on the ISC platform

  2. Scores paper-pencil tests [ Time Frame: 1.5 hours ]
    Scores retrieved from all paper-based cognitive tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Examinee's primary language (language most often spoken) must be English.
  • If examinee has vision impairment or hearing loss, must be corrected to normal.
  • Must have normal fine and gross motor ability
  • Must have use of fingers, hands, and arms to be able to use a pencil to write symbols.
  • Must be able to understand subtest instructions and participate fully in testing.

Exclusion Criteria:

  • Evidence of current cognitive impairment.
  • Disruptive behavior or insufficient compliance with testing to ensure a valid assessment.
  • Examinee must not be currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
  • Examinee must not be diagnosed with a neurological disorder or disease (e.g., Parkinson's, brain tumor, stroke, TBI, epilepsy [if # seizures ≤ 2 and not receiving ongoing treatment for seizures, and not currently seeking medical evaluation or attention related to seizures, examinee can be accepted], encephalitis, dementia, language disorder (expressive or mixed receptive/expressive excluded; articulation disorder is ok), learning disorder.
  • Must not have been unconscious related to traumatic brain injury or "medical condition" > 20 minutes (however, e.g., heat stroke, medication induced are ok) or any head-injury resulting in an overnight hospital stay.
  • Any history of a medical event requiring resuscitation in which examinee was non-responsive for > 15 minutes.
  • Must not have current or recent functional change (ability to carry out usual duties at work, in school, IADLs [driving, shopping, managing money], etc.) due to cognitive change.
  • Examinee must not be receiving chemotherapy treatment, or have received chemotherapy treatment in the past 2 months.
  • Examinee must not have a history of ECT or radiation to the CNS.
  • Examinee must not be (currently or in the past) diagnosed with a psychotic disorder, or currently diagnosed with a mood disorder (however, Major Depressive Disorder in remission or with no current episode, and Dysthymic and Adjustment Disorders, are acceptable) or an anxiety disorder with symptoms significant enough to interfere with optimal test performance.
  • Autoimmune disorder (e.g., LUPUS, Multiple Sclerosis)
  • Examinee must not be currently diagnosed with substance abuse or dependence, or have carried any substance abuse or dependence diagnosis in the past year (> 1 year in remission diagnoses are ok). Long term alcohol abusers are excluded as well (e.g., abused substance for more than 10 years).
  • Any history of Autism Spectrum Disorder or Intellectual Disability.
  • The examinee must not be currently taking medication that might impact test performance (e.g., anti-convulsants, antipsychotics, benzodiazepines, psychostimulants, opiods, tricyclic antidepressants, some norepinephrine reuptake inhibitors). Most antihypertensive medications and statins are acceptable.
  • If previously diagnosed with any physical condition or illness that might depress test performance, illness must not interfere with normal cognitive functioning at work, school, ADLs, etc. Diabetes, hypothyroidism, and hypertension are acceptable if controlled.
  • Exclude primarily nonverbal or uncommunicative. Must not have a diagnosis of aphasia.
  • Examinees should not have received neuropsychological testing although previous MMSE testing is allowed if more than 6 months prior
  • Examinee must not be seeking medical diagnostic procedures for cognitive difficulties from a medical professional.
  • Non-valid health insurance in USA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801382


Locations
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United States, Pennsylvania
Research America Inc.
Philadelphia, Pennsylvania, United States, 19073
Sponsors and Collaborators
Philips Electronics Nederland B.V. acting through Philips CTO organization
Research America Inc
Qserve
Factory CRO
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Responsible Party: Philips Electronics Nederland B.V. acting through Philips CTO organization
ClinicalTrials.gov Identifier: NCT03801382    
Other Study ID Numbers: ICBE-2-28674
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Philips Electronics Nederland B.V. acting through Philips CTO organization:
cognitive model
cognitive assessment
digital cognitive tests
automated scoring
algorithms