Cognitive Functioning of Healthy IndividualsNCT05210777
Norms and Validation for IntelliSpace Cognition Spanish Version
An observational study of Cognitive Functioning of Healthy Individuals and Hispanic, run by Philips Clinical & Medical Affairs Global at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Functioning of Healthy Individuals, Hispanic
- What is being tested?
- observation
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2022to 19 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
suAzio
Hollywood, California, 90028
suAzio
Hollywood, Florida, 33020
About this study
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.
- Being tested
- observation
- Keywords
- Cognitive model, Cognitive assessment, Digital cognitive tests, Automated scoring, Algorithms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationDevice
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start31 Jan 2022
- Primary completion15 Apr 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Functioning of Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- suAzio N.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210777
- Sponsor's protocol ID
- ICBE-S-000633
- Status last verified
- Jul 2022
- First submitted
- 14 Jan 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norms and Validation for IntelliSpace Cognition Spanish Version
- ClinicalTrials.gov ID
- NCT05210777
- Acronym / sponsor ID
- ICBE-S-000633
- Keywords
- Cognitive model, Cognitive assessment, Digital cognitive tests, Automated scoring, Algorithms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- suAzio N.V.
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to validate and provide applicable norms for the United States (US) Spanish versions of the IntelliSpace Cognition (ISC) neuropsychological tests.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (43 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationno intervention | Device | – |
Primary outcome
Validate the ISC Scores for Spanish Speaking population in US
Time frame: Two months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Functioning of Healthy Individuals and Hispanic, run by Philips Clinical & Medical Affairs Global at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the ISC Scores for Spanish Speaking population in US (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022; AzTrials last refreshed its copy on 2 Nov 2026.