Trial Outcomes & Findings for Psychometric Properties of IntelliSpace Cognition (NCT NCT03801382)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

450 participants

Primary outcome timeframe

1.5 hours

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
First Assessment STARTED	99	101	53	49	148
First Assessment COMPLETED	99	101	53	49	148
First Assessment NOT COMPLETED	0	0	0	0	0
Second Assessment STARTED	99	101	53	49	0
Second Assessment COMPLETED	99	101	53	49	0
Second Assessment NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Psychometric Properties of IntelliSpace Cognition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Digital / Paper n=99 Participants 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.	Paper / Digital n=101 Participants 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.	Digital / Digital n=53 Participants 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.	Paper / Paper n=49 Participants 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.	Digital n=148 Participants 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.	Total n=450 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 7 • n=5 Participants	66.3 years STANDARD_DEVIATION 7.5 • n=7 Participants	65.9 years STANDARD_DEVIATION 7.4 • n=5 Participants	65.7 years STANDARD_DEVIATION 7.3 • n=4 Participants	62 years STANDARD_DEVIATION 8.9 • n=21 Participants	64.9 years STANDARD_DEVIATION 8.1 • n=10 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	53 Participants n=7 Participants	29 Participants n=5 Participants	27 Participants n=4 Participants	79 Participants n=21 Participants	238 Participants n=10 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	48 Participants n=7 Participants	24 Participants n=5 Participants	22 Participants n=4 Participants	69 Participants n=21 Participants	212 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants	40 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	92 Participants n=7 Participants	48 Participants n=5 Participants	43 Participants n=4 Participants	134 Participants n=21 Participants	410 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	99 participants n=5 Participants	101 participants n=7 Participants	53 participants n=5 Participants	49 participants n=4 Participants	148 participants n=21 Participants	450 participants n=10 Participants
MMSE	27.6 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	27.6 units on a scale STANDARD_DEVIATION 2.1 • n=7 Participants	27.1 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	27.9 units on a scale STANDARD_DEVIATION 1.6 • n=4 Participants	27.8 units on a scale STANDARD_DEVIATION 1.7 • n=21 Participants	27.6 units on a scale STANDARD_DEVIATION 2.3 • n=10 Participants

PRIMARY outcome

Timeframe: 1.5 hours

Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.

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).

Outcome measures

Outcome measures
Measure	Total Sample n=300 Participants 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.
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
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
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
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
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
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
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

PRIMARY outcome

Timeframe: 1.5 hours

Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.

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).

Outcome measures

Outcome measures
Measure	Total Sample n=300 Participants 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.
Scores Digital (ISC) Tests Trail Making Test A (in seconds)	40.9 seconds Standard Deviation 12.4
Scores Digital (ISC) Tests Trail Making Test B (in seconds)	104.7 seconds Standard Deviation 55

PRIMARY outcome

Timeframe: 1.5 hours

Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.

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)

Outcome measures

Outcome measures
Measure	Total Sample n=300 Participants 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.
Scores Digital (ISC) Tests	.9 completion time/number correct words Standard Deviation .2

PRIMARY outcome

Timeframe: 1.5 hours

Population: Analyses were conducted for all groups who received a digital assessment combined. Only scores for the first assessment were included.

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).

Outcome measures

Outcome measures
Measure	Total Sample n=300 Participants 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.
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
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 outcome

Timeframe: 1.5 hours

Population: Descriptives

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).

Outcome measures

Outcome measures
Measure	Total Sample n=150 Participants 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.
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
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
Scores From Paper Tests Clock Test Copy (range 0-12, higher score indicating better outcome)	9.6 units on a scale Standard Deviation .7
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
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
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
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

PRIMARY outcome

Timeframe: 1.5 hours

Population: Descriptives

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).

Outcome measures

Outcome measures
Measure	Total Sample n=150 Participants 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.
Scores From Paper Tests Trail Making Test A (in seconds, higher indicating worse outcome)	33.9 seconds Standard Deviation 10.7
Scores From Paper Tests Trail Making Test B (in seconds, higher indicating worse outcome)	85 seconds Standard Deviation 48.6

PRIMARY outcome

Timeframe: 1.5 hours

Population: Descriptives

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)

Outcome measures

Outcome measures
Measure	Total Sample n=150 Participants 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.
Scores From Paper Tests	.8 completion time/number correct words Standard Deviation .3

PRIMARY outcome

Timeframe: 1.5 hours

Population: Descriptives

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).