Norms Expansion and Validation for IntelliSpace Cognition

Cognitive Functioning of Healthy Individuals Clinical Trial

Official title:

Norms Expansion and Validation for IntelliSpace Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729257
• Other study ID #: ICBE-S-000233
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: October 2021
• 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 expand the normative dataset for Philips IntelliSpace Cognition to include ages 18-49 and 80+ and aims to validate two new digital tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Functioning of Healthy Individuals

Intervention

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.

Locations

Country	Name	City	State
United States	Research America Inc.	Newtown Square	Pennsylvania

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform.		1.5 hours
Primary	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