Norms Expansion and Validation for IntelliSpace Cognition

NCT04729257 | Completed FDA Device

• 1 other identifier: ICBE-S-000233
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to expand the normative dataset for Philips IntelliSpace Cognition to include ages 18-49 and 80+ and aims to validate two new digital tests.

Conditions

Cognitive Functioning of Healthy Individuals

Keywords

Cognitive model; Cognitive assessment; Digital cognitive tests; Automated scoring; Algorithms

Outcome Measures

Primary Outcomes (2)

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

  1.5 hours

• or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests

  0.75 h or 1.5 hours

Study Arms (6)

Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)

OTHER

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

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

Group B (Validation, 18+)

OTHER

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

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

Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years)

OTHER

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

Device: Philips IntelliSpace Cognition (ISC).

Group D (Validation, 18+)

OTHER

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

Diagnostic Test: Paper-Pencil Tests.

Group E (Norms, 18-49 years)

OTHER

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

Device: Philips IntelliSpace Cognition (ISC).

Group F (Norms, 80-95 years)

OTHER

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

Device: Philips IntelliSpace Cognition (ISC).

Interventions

Philips IntelliSpace Cognition (ISC). DEVICE

Philips ISC is a Class-II Medical Device in the US that aids in assessing cognition and helps inform the HealthCare Professional (HCP) to make a diagnosis and treatment plan. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.

Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years); Group B (Validation, 18+); Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years); Group E (Norms, 18-49 years); Group F (Norms, 80-95 years)

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.

Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years); Group B (Validation, 18+); Group D (Validation, 18+)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 18 years or older.
• Participant's primary language (language most often spoken) must be American English.
• Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).
• Participant is able to hear well (naturally of corrected by means of a hearing aid).
• Participant is able to use their fingers, hands and arms to write symbols.
• Participant has valid health insurance in USA.
• Participant is able to give informed consent.
• Participant is able to understand test instructions and participate fully in testing.
• Participant has normal fine and gross motor ability.

You may not qualify if:

• Participant is 18 years or older.
• Participant's primary language (language most often spoken) must be American English.
• Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).
• Participant is able to hear well (naturally of corrected by means of a hearing aid).
• Participant is able to use their fingers, hands and arms to write symbols.
• Participant has valid health insurance in USA.
• Participant is able to give informed consent.
• Participant is able to understand test instructions and participate fully in testing.
• Participant has normal fine and gross motor ability.
• Participant is currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
• Participant is diagnosed with a neurological disorder or disease that may affect cognitive functioning (e.g., Parkinson's, brain tumor, stroke, Traumatic Brain Injury (TBI), epilepsy \[if # seizures ≤ 2 and not receiving ongoing treatment for seizures, and not currently seeking medical evaluation or attention related to seizures, participant can be accepted\], encephalitis, dementia).
• Participant is diagnosed with a language disorder or aphasia (expressive or mixed receptive/expressive) \[if articulation disorder, participant can be accepted\].
• Participant is diagnosed with a learning disorder.
• Participant is diagnosed with an autoimmune disorder that may affect cognitive functioning (e.g., LUPUS, Multiple Sclerosis).
• Participant is or was diagnosed with a current or past psychotic disorder (e.g., schizophrenia).

Sponsors & Collaborators

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

Study Sites (1)

Research America Inc.

Newtown Square, Pennsylvania, 19073, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: March 8, 2021
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)