Psychometric Properties of IntelliSpace Cognition

NCT03801382 | Completed Results FDA Device

• 1 other identifier: ICBE-2-28674
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Functioning of Healthy Individuals

Keywords

cognitive model; cognitive assessment; digital cognitive tests; automated scoring; algorithms

Outcome Measures

Primary Outcomes (4)

• Scores Digital (ISC) Tests

  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).

  1.5 hours

• Scores Digital (ISC) Tests

  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)

  1.5 hours

• Scores From Paper Tests

  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).

  1.5 hours

• Scores From Paper Tests

  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)

  1.5 hours

Study Arms (5)

Digital / Paper

OTHER

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

Device: IntelliSpace Cognition (ISC); Diagnostic Test: Paper-Pencil Tests

Paper / Digital

OTHER

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

Device: IntelliSpace Cognition (ISC); Diagnostic Test: Paper-Pencil Tests

Digital / Digital

OTHER

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

Device: IntelliSpace Cognition (ISC)

Paper / Paper

OTHER

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

Digital

OTHER

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

Device: IntelliSpace Cognition (ISC)

Interventions

IntelliSpace Cognition (ISC) DEVICE

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.

Digital; Digital / Digital; Digital / Paper; Paper / Digital

Paper-Pencil Tests DIAGNOSTIC_TEST

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 / Paper; Paper / Digital; Paper / Paper

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead
• Research America Inc.: collaborator
• Qserve: collaborator
• Factory CRO: collaborator

Study Sites (1)

Research America Inc.

Philadelphia, Pennsylvania, 19073, United States

Location

Results Point of Contact

• Title: Clinical product lead
• Organization: Philips Research

daisy.van.minde@philips.com

+31646802217

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: April 15, 2019
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Locations

US (1)