Psychometric Properties of IntelliSpace Cognition

Cognitive Functioning of Healthy Individuals Clinical Trial

Official title:

Study to Establish the Psychometric Properties of the Digital Cognitive Tests on the Philips IntelliSpace Cognition Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801382
• Other study ID #: ICBE-2-28674
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: August 26, 2019

Study information

• Verified date: May 2023
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.
• 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.
• Exclude primarily nonverbal or uncommunicative. Must not have a diagnosis of aphasia.
• Examinees should not have received neuropsychological testing although previous MMSE testing is allowed if more than 6 months prior
• Examinee must not be seeking medical diagnostic procedures for cognitive difficulties from a medical professional.
• Non-valid health insurance in USA.

Related Conditions & MeSH terms

• Cognitive Functioning of Healthy Individuals

Intervention

Device:
• IntelliSpace Cognition (ISC)
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.

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.

Locations

Country	Name	City	State
United States	Research America Inc.	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization	Factory CRO, Qserve, Research America Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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