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Norms Expansion and Validation for IntelliSpace Cognition

NCT04729257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2021-10-12

No results posted yet for this study

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

Interventions

DEVICE

Philips 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_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.

Sponsors & Collaborators

  • Research America Inc.

    collaborator INDUSTRY

  • Qserve

    collaborator INDUSTRY

  • Philips Electronics Nederland B.V. acting through Philips CTO organization

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-07-02
Completion
2021-07-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729257 on ClinicalTrials.gov