Study to Establish the Psychometric Properties of the Digital Cognitive Tests on the Philips IntelliSpace Cognition Platform
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive Functioning of Healthy Individuals
- Sponsor
- Philips Electronics Nederland B.V. acting through Philips CTO organization
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Scores Digital (ISC) Tests
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study aims to validate the tests that are on the IntelliSpace Cognition platform and to establish normative data for these tests.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Scores Digital (ISC) Tests
Time Frame: 1.5 hours
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)
Scores From Paper Tests
Time Frame: 1.5 hours
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)