Norms Expansion and Validation for IntelliSpace Cognition

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Functioning of Healthy Individuals
• Intervention / Treatment: Device: Philips IntelliSpace Cognition (ISC).; Diagnostic test: Paper-Pencil Tests.

• Study Type: Interventional
• Enrollment (Actual): 508
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Newtown Square, Pennsylvania, United States, 19073
      • Research America Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

• 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).
• Participant is diagnosed with a severe mood disorder [if Major Depressive Disorder in remission or with no current episode or Dysthymic Disorder or Adjustment Disorder, participant can be accepted].
• Participant is diagnosed with a severe anxiety disorder [if Phobia or Anxiety disorders with symptoms not significant enough to interfere with test performance, participant can be accepted].
• Participant is or was diagnosed with current or past Autism Spectrum Disorder or Intellectual Disability.
• Participant is diagnosed with a current substance abuse or dependence [if in remission ≥ 1 year, participant can be accepted].
• Participant has carried a substance abuse or dependence diagnosis for more than 10 years at any point in their life.
• Participant has an average alcohol consumption of 4 or more units per day.
• Participant uses medical marijuana.
• Participant uses recreational marijuana more than once a week.
• Participant uses recreational drugs other than alcohol and marijuana in the last 6 months (e.g., cocaine, ecstasy, LSD).
• Participant has been unconscious related to traumatic brain injury or 'medical condition' for more than 20 minutes [if medication-induced or due to heat stroke, participant can be accepted].
• Participant has stayed in a hospital overnight due to a head injury.
• Participant has had a medical event requiring resuscitation in which they were non-responsive for more than 15 minutes.
• Participant has received chemotherapy treatment in the past 2 months.
• Participant has received electroconvulsive therapy (ECT).
• Participant has received radiation to the central nervous system.
• Participant experiences a physical condition or illness that interferes with normal cognitive functioning at work, school, Instrumental Activities of Daily Living (IADLs) etc. [if diabetes or hypothyroidism or hypertension and if controlled, participant can be accepted].
• Participant is currently taking anti-convulsants (Depakote, Lamictal or Lyrica, Gabapentin, Keppra, Topamax, Divalproex Sodium, Valproate Sodium, Levetiracetam, Lamotrigine, Pregabalin, Topiramate).
• Participant is currently taking anti-psychotics (Abilify, Rexulti, Zyprexa, Clozaril, Clozapine, Latuda, Seroquel, Risperdal, Risperidone, Aripipazle, Bexipiprazole, Olanzapine, Lurasidone HCL, Quetiapine).
• Participant is currently taking benzodiazepines (Diazepams, Valium, Klonopin, Ativan, Xanax, Lorazepam, Alprazolam, Clonazepam).
• Participant is currently taking psychostimulants (Amphetamines, Adderall, Ritalin, Methamphetamines, Dextroamphetamine, Methylphenidate HCL). [if coffee, participant can be accepted].
• Participant is currently taking opioids (Oxycontin, Tramadol, Codeine, Dilaudid, Suboxone, Oxycodone, Percocet, Buprenorhine, Naloxone).
• Participant is currently taking antidepressants (Amitriptyline, Elavil, Pamelor, Tofranil, Vivactil, Imipramine, Protriptyline HCL). [if antidepressant that are not tricyclic, participant can be accepted].
• Participant is currently taking oxybutynin (Ditropan).
• Participant is currently seeking medical diagnostic procedures for cognitive difficulties from a medical professional.
• Participant has received neuropsychological testing before. [if previous MMSE(-2) or MoCA testing more than 6 months prior, participant can be accepted].
• Participant shows evidence of current cognitive impairment.
• Participant displays disruptive behavior or insufficient compliance with testing to ensure a valid assessment.
• Participant is primarily nonverbal or uncommunicative.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years); Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests.	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.
Other: Group B (Validation, 18+); Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests.	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.
Other: Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years); Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using digital tests.	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.
Other: Group D (Validation, 18+); 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.; 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.
Other: Group E (Norms, 18-49 years); Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A	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.
Other: Group F (Norms, 80-95 years); Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 tests	0.75 h or 1.5 hours

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Collaborators: Research America Inc; Qserve

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Algorithms; Cognitive assessment; Cognitive model; Digital cognitive tests; Automated scoring
• Other Study ID Numbers: ICBE-S-000233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No