Cognitive Functioning of Healthy Individuals
Conditions
Keywords
cognitive model, cognitive assessment, digital cognitive tests, automated scoring, algorithms
Brief summary
This study aims to validate the tests that are on the IntelliSpace Cognition platform and to establish normative data for these tests.
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.
Sponsors
Research America Inc.
Qserve
Factory CRO
Philips Electronics Nederland B.V. acting through Philips CTO organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores Digital (ISC) Tests | 1.5 hours | 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). |
| Scores From Paper Tests | 1.5 hours | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digital / Paper Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
IntelliSpace 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.
Paper-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. | 99 |
| Paper / Digital Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.
IntelliSpace 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.
Paper-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. | 101 |
| Digital / Digital Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.
IntelliSpace 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. | 53 |
| Paper / Paper Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
Paper-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. | 49 |
| Digital Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A
IntelliSpace 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. | 148 |
| Total | 450 |
Baseline characteristics
| Characteristic | Digital / Paper | Paper / Digital | Digital / Digital | Paper / Paper | Digital | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 7 | 66.3 years STANDARD_DEVIATION 7.5 | 65.9 years STANDARD_DEVIATION 7.4 | 65.7 years STANDARD_DEVIATION 7.3 | 62 years STANDARD_DEVIATION 8.9 | 64.9 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 5 Participants | 6 Participants | 14 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 92 Participants | 48 Participants | 43 Participants | 134 Participants | 410 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| MMSE | 27.6 units on a scale STANDARD_DEVIATION 1.9 | 27.6 units on a scale STANDARD_DEVIATION 2.1 | 27.1 units on a scale STANDARD_DEVIATION 1.9 | 27.9 units on a scale STANDARD_DEVIATION 1.6 | 27.8 units on a scale STANDARD_DEVIATION 1.7 | 27.6 units on a scale STANDARD_DEVIATION 2.3 |
| Region of Enrollment United States | 99 participants | 101 participants | 53 participants | 49 participants | 148 participants | 450 participants |
| Sex: Female, Male Female | 50 Participants | 53 Participants | 29 Participants | 27 Participants | 79 Participants | 238 Participants |
| Sex: Female, Male Male | 49 Participants | 48 Participants | 24 Participants | 22 Participants | 69 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 101 | 0 / 53 | 0 / 49 | 0 / 148 |
| other Total, other adverse events | 0 / 99 | 0 / 101 | 0 / 53 | 0 / 49 | 0 / 148 |
| serious Total, serious adverse events | 0 / 99 | 0 / 101 | 0 / 53 | 0 / 49 | 0 / 148 |
Outcome results
Primary
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
Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Sample | Scores Digital (ISC) Tests | Rey Auditory Verbal Learning Test (score range 0-45, higher score indicates better outcome) | 41.3 units on a scale | Standard Deviation 9.5 |
| Total Sample | Scores Digital (ISC) Tests | Clock Test Drawing (on scale from 0-22, higher score indicates better outcome) | 17.9 units on a scale | Standard Deviation 3.9 |
| Total Sample | Scores Digital (ISC) Tests | Clock Test Copy (on scale from 0-22, higher score indicates better outcome) | 19.3 units on a scale | Standard Deviation 2.3 |
| Total Sample | Scores Digital (ISC) Tests | Rey Osterrieth Complex Figure Test Copy (scale 0-36, higher score indicating better outcome) | 29.1 units on a scale | Standard Deviation 6.6 |
| Total Sample | Scores Digital (ISC) Tests | Rey Osterrieth Complex Figure Test Recall (scale 0-36, higher score indicating better outcome) | 9.5 units on a scale | Standard Deviation 6.3 |
| Total Sample | Scores Digital (ISC) Tests | Digit Span forward (number of items correct, range 0-12, higher score indicating better outcome) | 7.8 units on a scale | Standard Deviation 2.2 |
| Total Sample | Scores Digital (ISC) Tests | Digit Span backward (number of items correct, range 0-12, higher score indicating better outcome) | 6.5 units on a scale | Standard Deviation 2.5 |
p-value: >0.05t-test, 2 sided
Primary
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
Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Sample | Scores Digital (ISC) Tests | Trail Making Test A (in seconds) | 40.9 seconds | Standard Deviation 12.4 |
| Total Sample | Scores Digital (ISC) Tests | Trail Making Test B (in seconds) | 104.7 seconds | Standard Deviation 55 |
Primary
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
Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Scores Digital (ISC) Tests | .9 completion time/number correct words | Standard Deviation 0.2 |
Primary
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
Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Sample | Scores Digital (ISC) Tests | Letter Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome) | 38.7 number of words | Standard Deviation 11 |
| Total Sample | Scores Digital (ISC) Tests | Category Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome) | 45.9 number of words | Standard Deviation 9.5 |
Primary
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
Population: Descriptives
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Sample | Scores From Paper Tests | Rey Osterrieth Complex Figure Test Recall (range 0-36, higher score indicating better outcome) | 11.2 units on a scale | Standard Deviation 6.1 |
| Total Sample | Scores From Paper Tests | Digit Span forward (number of correct items, range 0-12, higher indicating better outcome) | 8 units on a scale | Standard Deviation 2.1 |
| Total Sample | Scores From Paper Tests | Digit Span backward (number of correct items, range 0-12, higher indicating better outcome) | 6.2 units on a scale | Standard Deviation 2 |
| Total Sample | Scores From Paper Tests | Rey Auditory Verbal Learning Test (range 0-45, higher score indicating better outcome) | 41.3 units on a scale | Standard Deviation 8.1 |
| Total Sample | Scores From Paper Tests | Clock Test Drawing (range 0-12, higher score indicating better outcome) | 8.1 units on a scale | Standard Deviation 2.4 |
| Total Sample | Scores From Paper Tests | Clock Test Copy (range 0-12, higher score indicating better outcome) | 9.6 units on a scale | Standard Deviation 0.7 |
| Total Sample | Scores From Paper Tests | Rey Osterrieth Complex Figure Test Copy (range 0-36, higher score indicating better outcome) | 27.2 units on a scale | Standard Deviation 6.8 |
Primary
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
Population: Descriptives
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Sample | Scores From Paper Tests | Trail Making Test A (in seconds, higher indicating worse outcome) | 33.9 seconds | Standard Deviation 10.7 |
| Total Sample | Scores From Paper Tests | Trail Making Test B (in seconds, higher indicating worse outcome) | 85 seconds | Standard Deviation 48.6 |
Primary
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
Population: Descriptives
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sample | Scores From Paper Tests | .8 completion time/number correct words | Standard Deviation 0.3 |
Primary
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
Population: Descriptives
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Sample | Scores From Paper Tests | Letter Fluency Test (sum of correct words during 3 trials, higher indicating better outcome) | 41 number of words | Standard Deviation 11.9 |
| Total Sample | Scores From Paper Tests | Category Fluency Test (sum of correct words in 3 trials, higher score indicating better outcome) | 46 number of words | Standard Deviation 9.2 |