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CompletedNCT03801382Updated Jun 22, 2023Results posted

Psychometric Properties of IntelliSpace Cognition

An interventional study of IntelliSpace Cognition (ISC) and Paper-Pencil Tests in Cognitive Functioning of Healthy Individuals, sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Philips Electronics Nederland B.V. acting through Philips CTO organization · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

This study aims to validate the tests that are on the IntelliSpace Cognition platform and to establish normative data for these tests.

02

Conditions studied

  • Cognitive Functioning of Healthy Individuals

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
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Examinee's primary language (language most often spoken) must be English.
  • If examinee has vision impairment or hearing loss, must be corrected to normal.
  • Must have normal fine and gross motor ability
  • Must have use of fingers, hands, and arms to be able to use a pencil to write symbols.
  • Must be able to understand subtest instructions and participate fully in testing.

Exclusion criteria

Exclusion Criteria:

  • Evidence of current cognitive impairment.
  • Disruptive behavior or insufficient compliance with testing to ensure a valid assessment.
  • Examinee must not be currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
  • Examinee must not be diagnosed with a neurological disorder or disease (e.g., Parkinson's, brain tumor, stroke, TBI, epilepsy [if # seizures ≤ 2 and not receiving ongoing treatment for seizures, and not currently seeking medical evaluation or attention related to seizures, examinee can be accepted], encephalitis, dementia, language disorder (expressive or mixed receptive/expressive excluded; articulation disorder is ok), learning disorder.
  • Must not have been unconscious related to traumatic brain injury or "medical condition" > 20 minutes (however, e.g., heat stroke, medication induced are ok) or any head-injury resulting in an overnight hospital stay.
  • Any history of a medical event requiring resuscitation in which examinee was non-responsive for > 15 minutes.
  • Must not have current or recent functional change (ability to carry out usual duties at work, in school, IADLs [driving, shopping, managing money], etc.) due to cognitive change.
  • Examinee must not be receiving chemotherapy treatment, or have received chemotherapy treatment in the past 2 months.
  • Examinee must not have a history of ECT or radiation to the CNS.
  • Examinee must not be (currently or in the past) diagnosed with a psychotic disorder, or currently diagnosed with a mood disorder (however, Major Depressive Disorder in remission or with no current episode, and Dysthymic and Adjustment Disorders, are acceptable) or an anxiety disorder with symptoms significant enough to interfere with optimal test performance.
  • Autoimmune disorder (e.g., LUPUS, Multiple Sclerosis)
  • Examinee must not be currently diagnosed with substance abuse or dependence, or have carried any substance abuse or dependence diagnosis in the past year (> 1 year in remission diagnoses are ok). Long term alcohol abusers are excluded as well (e.g., abused substance for more than 10 years).
  • Any history of Autism Spectrum Disorder or Intellectual Disability.
  • The examinee must not be currently taking medication that might impact test performance (e.g., anti-convulsants, antipsychotics, benzodiazepines, psychostimulants, opiods, tricyclic antidepressants, some norepinephrine reuptake inhibitors). Most antihypertensive medications and statins are acceptable.
  • If previously diagnosed with any physical condition or illness that might depress test performance, illness must not interfere with normal cognitive functioning at work, school, ADLs, etc. Diabetes, hypothyroidism, and hypertension are acceptable if controlled.
  • Exclude primarily nonverbal or uncommunicative. Must not have a diagnosis of aphasia.
  • Examinees should not have received neuropsychological testing although previous MMSE testing is allowed if more than 6 months prior
  • Examinee must not be seeking medical diagnostic procedures for cognitive difficulties from a medical professional.
  • Non-valid health insurance in USA.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
450 participants (actual)

Study arms

  • Other
    Digital / Paper

    Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.

    Device: IntelliSpace Cognition (ISC) · Diagnostic Test: Paper-Pencil Tests

  • Other
    Paper / Digital

    Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.

    Device: IntelliSpace Cognition (ISC) · Diagnostic Test: Paper-Pencil Tests

  • Other
    Digital / Digital

    Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.

    Device: IntelliSpace Cognition (ISC)

  • Other
    Paper / Paper

    Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.

    Diagnostic Test: Paper-Pencil Tests

  • Other
    Digital

    Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A

    Device: IntelliSpace Cognition (ISC)

Interventions

  • DeviceIntelliSpace Cognition (ISC)

    Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.

  • Diagnostic testPaper-Pencil Tests

    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.

06

What researchers measure

Primary outcomes

  1. Scores Digital (ISC) Tests

    Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

    Time frame: 1.5 hours

  2. Scores Digital (ISC) Tests

    Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT). Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)

    Time frame: 1.5 hours

  3. Scores From Paper Tests

    Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

    Time frame: 1.5 hours

  4. Scores From Paper Tests

    Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT). Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)

    Time frame: 1.5 hours

07

Results

Posted Jun 22, 2023

Participant flow

First Assessment
Participant flow — First Assessment
MilestoneDigital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigital
Started991015349148
Completed991015349148
Not completed00000
Second Assessment
Participant flow — Second Assessment
MilestoneDigital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigital
Started9910153490
Completed9910153490
Not completed00000

Outcome measures

PrimaryScores Digital (ISC) Tests

Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

Time frame:
1.5 hours
Reported as:
Mean · units on a scale
Scores Digital (ISC) Tests
units on a scaleTotal Sample
Rey Auditory Verbal Learning Test (score range 0-45, higher score indicates better outcome)41.3 ± 9.5
Clock Test Drawing (on scale from 0-22, higher score indicates better outcome)17.9 ± 3.9
Clock Test Copy (on scale from 0-22, higher score indicates better outcome)19.3 ± 2.3
Rey Osterrieth Complex Figure Test Copy (scale 0-36, higher score indicating better outcome)29.1 ± 6.6
Rey Osterrieth Complex Figure Test Recall (scale 0-36, higher score indicating better outcome)9.5 ± 6.3
Digit Span forward (number of items correct, range 0-12, higher score indicating better outcome)7.8 ± 2.2
Digit Span backward (number of items correct, range 0-12, higher score indicating better outcome)6.5 ± 2.5
Statistical analysis
  • Total Sample · t-test, 2 sided · p = >.05 · Mean difference (final values): .05
PrimaryScores Digital (ISC) Tests

Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

Time frame:
1.5 hours
Reported as:
Mean · seconds
Scores Digital (ISC) Tests
secondsTotal Sample
Trail Making Test A (in seconds)40.9 ± 12.4
Trail Making Test B (in seconds)104.7 ± 55
PrimaryScores Digital (ISC) Tests

Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT). Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)

Time frame:
1.5 hours
Reported as:
Mean · completion time/number correct words
Scores Digital (ISC) Tests
completion time/number correct wordsTotal Sample
Scores Digital (ISC) Tests.9 ± .2
PrimaryScores Digital (ISC) Tests

Scores retrieved from all cognitive tests on the ISC platform The cognitive tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

Time frame:
1.5 hours
Reported as:
Mean · number of words
Scores Digital (ISC) Tests
number of wordsTotal Sample
Letter Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome)38.7 ± 11
Category Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome)45.9 ± 9.5
PrimaryScores From Paper Tests

Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

Time frame:
1.5 hours
Reported as:
Mean · units on a scale
Scores From Paper Tests
units on a scalePaper-pencil Group
Rey Auditory Verbal Learning Test (range 0-45, higher score indicating better outcome)41.3 ± 8.1
Clock Test Drawing (range 0-12, higher score indicating better outcome)8.1 ± 2.4
Clock Test Copy (range 0-12, higher score indicating better outcome)9.6 ± .7
Rey Osterrieth Complex Figure Test Copy (range 0-36, higher score indicating better outcome)27.2 ± 6.8
Rey Osterrieth Complex Figure Test Recall (range 0-36, higher score indicating better outcome)11.2 ± 6.1
Digit Span forward (number of correct items, range 0-12, higher indicating better outcome)8 ± 2.1
Digit Span backward (number of correct items, range 0-12, higher indicating better outcome)6.2 ± 2
PrimaryScores From Paper Tests

Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

Time frame:
1.5 hours
Reported as:
Mean · seconds
Scores From Paper Tests
secondsPaper-pencil Group
Trail Making Test A (in seconds, higher indicating worse outcome)33.9 ± 10.7
Trail Making Test B (in seconds, higher indicating worse outcome)85 ± 48.6
PrimaryScores From Paper Tests

Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT). Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)

Time frame:
1.5 hours
Reported as:
Mean · completion time/number correct words
Scores From Paper Tests
completion time/number correct wordsPaper-pencil Group
Scores From Paper Tests.8 ± .3
PrimaryScores From Paper Tests

Scores from paper tests The paper cognitive tests included are the same as the tests included on the ISC platform are commonly used in neuropsychological assessments and measure aspects of executive functioning (TMT A, TMT B, Star Cancellation Test, RAVLT, Letter Fluency Test, Category Fluency Test, ROCFT, Digit Span Forward, Digit Span Backward), processing speed (Star Cancellation Test), working memory (TMT A, TMT B, Star Cancellation Test, Letter Fluency Test, Digit Span Forward, Digit Span Backward), memory (RAVLT), verbal processing (Letter Fluency Test, Category Fluency Test), and visual-spatial processing (RAVLT, ROCFT).

Time frame:
1.5 hours
Reported as:
Mean · number of words
Scores From Paper Tests
number of wordsPaper-pencil Group
Letter Fluency Test (sum of correct words during 3 trials, higher indicating better outcome)41 ± 11.9
Category Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome)46 ± 9.2

Adverse events

Collected over For each participant, an assessment took approximately 1.5 hours. Any adverse events during this time period were recorded and reported within 24 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Digital / Paper0/99 (0%)0/99 (0%)0/99 (0%)
Paper / Digital0/101 (0%)0/101 (0%)0/101 (0%)
Digital / Digital0/53 (0%)0/53 (0%)0/53 (0%)
Paper / Paper0/49 (0%)0/49 (0%)0/49 (0%)
Digital0/148 (0%)0/148 (0%)0/148 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Digital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigitalTotal
Mean67.2 ± 766.3 ± 7.565.9 ± 7.465.7 ± 7.362 ± 8.964.9 ± 8.1
Sex: Female, Male
Sex: Female, Male(Participants)Digital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigitalTotal
Female5053292779238
Male4948242269212
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Digital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigitalTotal
Hispanic or Latino69561440
Not Hispanic or Latino93924843134410
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(participants)Digital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigitalTotal
United States991015349148450
MMSE
MMSE(units on a scale)Digital / PaperPaper / DigitalDigital / DigitalPaper / PaperDigitalTotal
Mean27.6 ± 1.927.6 ± 2.127.1 ± 1.927.9 ± 1.627.8 ± 1.727.6 ± 2.3
08

Study locations

1 site
  • Research America Inc.
    Philadelphia, Pennsylvania 19073, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03801382
Lead sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Research America Inc., Qserve, Factory CRO
Responsible party
Sponsor
First posted
Jan 11, 2019
Start date
Apr 15, 2019
Primary completion
Aug 26, 2019
Completion
Aug 26, 2019
Results posted
Jun 22, 2023
Last update
Jun 22, 2023

Oversight

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

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