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CompletedNCT05210777Updated Jul 18, 2022

Norms and Validation for IntelliSpace Cognition Spanish Version

An observational study in Cognitive Functioning of Healthy Individuals and Hispanic, sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
99
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to validate and provide applicable norms for the United States (US) Spanish versions of the IntelliSpace Cognition (ISC) neuropsychological tests.

Read the detailed description

The study will collect test scores from the Spanish speaking Hispanic US population for Spanish translations/adaptations of the ISC tests with the aim to assess how the Spanish language version of ISC tests compare to the English language version of ISC tests, and to create norms for the Spanish language version of the tests.

02

Conditions studied

  • Cognitive Functioning of Healthy Individuals
  • Hispanic

Keywords

  • Cognitive model
  • Cognitive assessment
  • Digital cognitive tests
  • Automated scoring
  • Algorithms
03

In context

Lead sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study population is healthy Spanish-speaking adult participants from the US Hispanic subpopulation, with various sex, age, and education levels. All participants will be aged 18 years or older.

Inclusion criteria

  • Self-reported:
  • Participant is 18 years or older.
  • Participant considers herself or himself to be Hispanic/Latino.
  • Participant has Spanish as their primary and dominant language, or reports speaking Spanish as equally as good as she or he speaks English.
  • Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).
  • Participant is able to hear well (naturally or 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.

Investigator observed:

  • 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

Exclusion Criteria:

  • Self-reported:
  • Participant has participated in previous studies where IntelliSpace Cognition was used (PJ-011726: "Study to establish the psychometric properties of the digital cognitive tests on the Philips IntelliSpace Cognition Platform" conducted during 2019 or ICBE-S-000233: "Norms Expansion and Validation for IntelliSpace Cognition" conducted during 2021).
  • 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, encephalitis, dementia).

Admissible: Epilepsy with no more than 2 seizures and not currently receiving epilepsy treatment and not currently seeking medical attention related to seizures.

  • Participant is diagnosed with a language disorder or aphasia (expressive or mixed receptive/expressive).

Admissible: Articulation disorder.

  • 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. Admissible: Major Depressive Disorder in remission / Major Depressive Disorder with no current episode / Dysthymic Disorder / Adjustment Disorder
  • Participant is diagnosed with a severe anxiety disorder. Admissible: Phobia / Anxiety disorders with symptoms not significant enough to interfere with test performance.
  • 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. Admissible: In remission for at least 1 year.
  • 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.

Admissible: Medication-induced or due to heat stroke.

  • 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.

Admissible: Diabetes, hypothyroidism, hypertension if controlled.

  • Participant is currently taking anti-convulsants (e.g. Depakote, Lamictal or Lyrica, Gabapentin, Keppra, Topamax, Divalproex Sodium, Valproate Sodium, Levetiracetam, Lamotrigine, Pregabalin, Topiramate).
  • Participant is currently taking anti-psychotics (e.g. Abilify, Rexulti, Zyprexa, Clozaril, Clozapine, Latuda, Seroquel, Risperdal, Risperidone, Aripipazle, Bexipiprazole, Olanzapine, Lurasidone HCL, Quetiapine).
  • Participant is currently taking benzodiazepines (e.g. Diazepams, Valium, Klonopin, Ativan, Xanax, Lorazepam, Alprazolam, Clonazepam).
  • Participant is currently taking psychostimulants (e.g. Amphetamines, Adderall, Ritalin, Methamphetamines, Dextroamphetamine, Methylphenidate HCL).

Admissible: Coffee.

  • Participant is currently taking opioids (e.g. Oxycontin, Tramadol, Codeine, Dilaudid, Suboxone, Oxycodone, Percocet, Buprenorhine, Naloxone).
  • Participant is currently taking antidepressants (e.g. Amitriptyline, Elavil, Pamelor, Tofranil, Vivactil, Imipramine, Protriptyline HCL).

Admissible: Antidepressants that are not tricyclic.

  • 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. Admissible: Previous MMSE (-2) or MoCA testing more than 6 months prior.

Investigator observed:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
99 participants (actual)
Patient registry
No

Interventions

  • Deviceobservation

    no intervention

06

What researchers measure

Primary outcomes

  1. Validate the ISC Scores for Spanish Speaking population in US

    To collect test scores from Spanish speaking Hispanic US population for Spanish translations/adaptations of the ISC tests with the aim to assess how the Spanish language version of ISC tests compare to the English language version of ISC tests, and to create norms for the Spanish language version of the tests.

    Time frame: Two months

07

Study locations

2 sites
  • suAzio
    Hollywood, California 90028, United States
  • suAzio
    Hollywood, Florida 33020, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05210777
Lead sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
suAzio N.V.
Responsible party
Sponsor
First posted
Jan 27, 2022
Start date
Jan 31, 2022
Primary completion
Apr 15, 2022
Completion
May 19, 2022
Last update
Jul 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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