Clinical trial NCT04729257: Norms Expansion and Validation for IntelliSpace Cognition
Official title: Norms Expansion and Validation for IntelliSpace Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Functioning of Healthy Individuals
Keywords: Cognitive model
Cognitive assessment
Digital cognitive tests
Automated scoring
Algorithms
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
Collaborators: name: Research America Inc.
name: Qserve
First posted: 2021-01-28
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: 1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform.
timeFrame: 1.5 hours
measure: or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests
timeFrame: 0.75 h or 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newtown Square
country: United States
facility: Research America Inc.
state: Pennsylvania
Study officials:
References: