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Norms Expansion and Validation for IntelliSpace Cognition

Norms Expansion and Validation for IntelliSpace Cognition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04729257
Enrollment
508
Registered
2021-01-28
Start date
2021-03-08
Completion date
2021-07-02
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Functioning of Healthy Individuals

Keywords

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

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.

Interventions

DEVICEPhilips IntelliSpace Cognition (ISC).

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.

DIAGNOSTIC_TESTPaper-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.

Sponsors

Research America Inc.
CollaboratorINDUSTRY
Qserve
CollaboratorINDUSTRY
Philips Electronics Nederland B.V. acting through Philips CTO organization
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

Inclusion Criteria: * 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.

Design outcomes

Primary

MeasureTime frame
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 tests0.75 h or 1.5 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026