Norms Expansion and Validation for IntelliSpace Cognition

• ClinicalTrials.gov Identifier: NCT04729257
• Recruitment Status: Completed
• First Posted: January 28, 2021
• Last Update Posted: October 12, 2021
• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Collaborators: Research America Inc; Qserve
• Information provided by (Responsible Party): Philips Electronics Nederland B.V. acting through Philips CTO organization

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cognitive Functioning of Healthy Individuals	Device: Philips IntelliSpace Cognition (ISC).; Diagnostic Test: Paper-Pencil Tests.	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 508 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Norms Expansion and Validation for IntelliSpace Cognition
• Actual Study Start Date: March 8, 2021
• Actual Primary Completion Date: July 2, 2021
• Actual Study Completion Date: July 2, 2021

Arms and Interventions

Arm	Intervention/treatment
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.
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.
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.
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.
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.
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.

Outcome Measures

Primary Outcome Measures :

1. 1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform. [ Time Frame: 1.5 hours ]
2. or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests [ Time Frame: 0.75 h or 1.5 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

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.

Contacts and Locations

Locations

United States, Pennsylvania

Research America Inc.

Newtown Square, Pennsylvania, United States, 19073

Sponsors and Collaborators

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

Research America Inc

Qserve

More Information

• Responsible Party: Philips Electronics Nederland B.V. acting through Philips CTO organization
• ClinicalTrials.gov Identifier: NCT04729257
• Other Study ID Numbers: ICBE-S-000233
• First Posted: January 28, 2021
• Last Update Posted: October 12, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Philips Electronics Nederland B.V. acting through Philips CTO organization:

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