Norms Expansion and Validation for IntelliSpace Cognition

Philips

Status: Completed

Conditions: Cognitive Functioning of Healthy Individuals

Treatments: Device: Philips IntelliSpace Cognition (ISC).; Diagnostic Test: Paper-Pencil Tests.

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04729257

ICBE-S-000233

Details and patient eligibility

About

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.

Enrollment: 508 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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508 participants in 6 patient groups

Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)

Other group

Description:

Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests.

Treatment:

Diagnostic Test: Paper-Pencil Tests.

Device: Philips IntelliSpace Cognition (ISC).

Group B (Validation, 18+)

Other group

Description:

Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests.

Treatment:

Diagnostic Test: Paper-Pencil Tests.

Device: Philips IntelliSpace Cognition (ISC).

Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years)

Other group

Description:

Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using digital tests.

Treatment:

Device: Philips IntelliSpace Cognition (ISC).

Group D (Validation, 18+)

Other group

Description:

Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using paper-pencil tests.

Treatment:

Diagnostic Test: Paper-Pencil Tests.

Group E (Norms, 18-49 years)

Other group

Description:

Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A

Treatment:

Device: Philips IntelliSpace Cognition (ISC).

Group F (Norms, 80-95 years)

Other group

Description:

Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A

Treatment:

Device: Philips IntelliSpace Cognition (ISC).