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Cognitive Functioning of Healthy IndividualsNCT04729257

Norms Expansion and Validation for IntelliSpace Cognition

A study testing Philips IntelliSpace Cognition (ISC). and Paper-Pencil Tests. in people with Cognitive Functioning of Healthy Individuals, run by Philips Clinical & Medical Affairs Global at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 yearsHealthy volunteers can take part
What is being tested?
Philips IntelliSpace Cognition (ISC). and Paper-Pencil Tests.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
1 siteUnited States
Study dates
8 Mar 2021to 2 Jul 2021
Phase
Interventional
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 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.

Who cannot join

  • 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).
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  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Research America Inc.

    Newtown Square, Pennsylvania, 19073

Other trials in United States

About this study

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.

Being tested
Philips IntelliSpace Cognition (ISC)., Paper-Pencil Tests.
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.

  • Philips IntelliSpace Cognition (ISC).Device

    Philips ISC is a Class-II Medical Device in the US that aids in assessing cognition and helps inform the HealthCare Professional (HCP) to make a diagnosis and treatment plan. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.

  • Paper-Pencil Tests.Diagnostic test

    The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.

Study groups in NCT04729257
Study groupRoleWhat they receive
Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)OtherVisit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests.
Receives: Device: Philips IntelliSpace Cognition (ISC).; Diagnostic Test: Paper-Pencil Tests.
Group B (Validation, 18+)OtherVisit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests.
Receives: Device: Philips IntelliSpace Cognition (ISC).; Diagnostic Test: Paper-Pencil Tests.
Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years)OtherVisit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using digital tests.
Receives: Device: Philips IntelliSpace Cognition (ISC).
Group D (Validation, 18+)OtherVisit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using paper-pencil tests.
Receives: Diagnostic Test: Paper-Pencil Tests.
Group E (Norms, 18-49 years)OtherVisit 1: Participants' cognition is measured using digital tests. Visit 2: N/A
Receives: Device: Philips IntelliSpace Cognition (ISC).
Group F (Norms, 80-95 years)OtherVisit 1: Participants' cognition is measured using digital tests. Visit 2: N/A
Receives: Device: Philips IntelliSpace Cognition (ISC).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform.

    Measured: 1.5 hours

  2. or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests

    Measured: 0.75 h or 1.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2021
  2. Study start8 Mar 2021
  3. Primary completion2 Jul 2021
  4. Study completion2 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04729257
Sponsor's protocol ID
ICBE-S-000233
Status last verified
Oct 2021
First submitted
25 Jan 2021
Last updated
12 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Philips IntelliSpace Cognition (ISC). and Paper-Pencil Tests. in people with Cognitive Functioning of Healthy Individuals, run by Philips Clinical & Medical Affairs Global at 1 site 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 18 inclusion and 34 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform. (time frame: 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729257.

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 12 Oct 2021.

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