Norms and Validation for IntelliSpace Cognition Spanish Version

NCT05210777 | Completed FDA Device

• 1 other identifier: ICBE-S-000633
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cognitive Functioning of Healthy Individuals; Hispanic

Keywords

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

Outcome Measures

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.

  Two months

Interventions

observation DEVICE

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead
• suAzio N.V.: collaborator

Study Sites (2)

suAzio

Hollywood, California, 90028, United States

Location

suAzio

Hollywood, Florida, 33020, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 31, 2022
• Primary Completion: April 15, 2022
• Study Completion: May 19, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)