Cognitive Functioning of Healthy IndividualsNCT03801382

Psychometric Properties of IntelliSpace Cognition

A study testing 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

Search all trials

Trial summary

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

Who is it for?: Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Cognitive Functioning of Healthy Individuals
What is being tested?: 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: 450 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2019to 26 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research America Inc.
Philadelphia, Pennsylvania, 19073

Other trials in United States

About this study

Official title: Study to Establish the Psychometric Properties of the Digital Cognitive Tests on the Philips IntelliSpace Cognition Platform

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

Conditions: Cognitive Functioning of Healthy Individuals
Being tested: 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.

IntelliSpace Cognition (ISC)Device
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 TestsDiagnostic 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 NCT03801382
Study group	Role	What they receive
Digital / Paper	Other	Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests. Receives: Device: IntelliSpace Cognition (ISC); Diagnostic Test: Paper-Pencil Tests
Paper / Digital	Other	Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests. Receives: Device: IntelliSpace Cognition (ISC); Diagnostic Test: Paper-Pencil Tests
Digital / Digital	Other	Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests. Receives: Device: IntelliSpace Cognition (ISC)
Paper / Paper	Other	Phase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests. Receives: Diagnostic Test: Paper-Pencil Tests
Digital	Other	Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A Receives: Device: IntelliSpace Cognition (ISC)

What is being measured

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

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).
Measured: 1.5 hours
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)
Measured: 1.5 hours
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).
Measured: 1.5 hours
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)
Measured: 1.5 hours

Timeline

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

15 Apr 201926 Aug 2019

First posted11 Jan 2019
Study start15 Apr 2019
Primary completion26 Aug 2019
Study completion26 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03801382
Sponsor's protocol ID: ICBE-2-28674
Status last verified: May 2023
First submitted: 9 Jan 2019
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruitingObservational study
Outdoor vs. Indoor Exercises and Cognitive Functions in Older Adults
Exercise Environment and Cognitive Performance in Older Adults
RecruitingObservational study
Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD
COPD, Health Literacy
Recruiting
Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Healthy Aging
Not yet recruitingObservational study
Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT
Hyperbaric Oxygenation, Cardiorespiratory Fitness

All Cognitive Functioning of Healthy Individuals trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Establish the Psychometric Properties of the Digital Cognitive Tests on the Philips IntelliSpace Cognition Platform
ClinicalTrials.gov ID: NCT03801382
Acronym / sponsor ID: ICBE-2-28674
Conditions: Cognitive Functioning of Healthy Individuals
Keywords: cognitive model, cognitive assessment, digital cognitive tests, automated scoring, algorithms
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
Collaborators: Research America Inc., Qserve, Factory CRO
Study start: 15 Apr 2019 (actual)
Primary completion: 26 Aug 2019 (actual)
Study completion: 26 Aug 2019 (actual)
First posted: 11 Jan 2019 (actual)
Results: Posted 22 Jun 2023

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Digital / Paper	Other	Device: IntelliSpace Cognition (ISC), Diagnostic Test: Paper-Pencil TestsPhase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
Paper / Digital	Other	Device: IntelliSpace Cognition (ISC), Diagnostic Test: Paper-Pencil TestsPhase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using digital tests.
Digital / Digital	Other	Device: IntelliSpace Cognition (ISC)Phase 1: Participants' cognition is measured using digital tests. Phase 2: Participants' cognition is measured using digital tests.
Paper / Paper	Other	Diagnostic Test: Paper-Pencil TestsPhase 1: Participants' cognition is measured using paper-pencil tests. Phase 2: Participants' cognition is measured using paper-pencil tests.
Digital	Other	Device: IntelliSpace Cognition (ISC)Phase 1: Participants' cognition is measured using digital tests. Phase 2: N/A

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (19 listed)

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.

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
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.	Device	Digital, Digital / Digital, Digital / Paper, Paper / Digital
Paper-Pencil TestsThe 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.	Diagnostic test	Digital / Paper, Paper / Digital, Paper / Paper

Primary outcome

Scores Digital (ISC) Tests
Time frame: 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 Digital (ISC) Tests
Time frame: 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). Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)
Scores From Paper Tests
Time frame: 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).
Scores From Paper Tests
Time frame: 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). Star Cancellation Test (completion time divided by number of correct cancellations, higher=worse)

Results and safety

Results posted to the registry on 22 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Digital / Paper	99	99
Paper / Digital	101	101
Digital / Digital	53	53
Paper / Paper	49	49
Digital	148	148

Primary outcome: Scores Digital (ISC) Tests

Time frame: 1.5 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Total Sample n = 300
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)

Total Sample: Mean Difference (Final Values): .05, p >.05, t-test, 2 sided

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

Primary outcome: Scores Digital (ISC) Tests

Time frame: 1.5 hours. Mean (Standard Deviation). Unit: seconds

Measure	Total Sample n = 300
Trail Making Test A (in seconds)	40.9 (12.4)
Trail Making Test B (in seconds)	104.7 (55)

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

Primary outcome: Scores Digital (ISC) Tests

Time frame: 1.5 hours. Mean (Standard Deviation). Unit: completion time/number correct words

Measure	Total Sample n = 300
Value	.9 (.2)

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

Primary outcome: Scores Digital (ISC) Tests

Time frame: 1.5 hours. Mean (Standard Deviation). Unit: number of words

Measure	Total Sample n = 300
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)

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

Adverse events

Time frame: For each participant, an assessment took approximately 1.5 hours. Any adverse events during this time period were recorded and reported within 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digital / Paper	0 of 99 (0%)	0 of 99 (0%)	0 of 99
Paper / Digital	0 of 101 (0%)	0 of 101 (0%)	0 of 101
Digital / Digital	0 of 53 (0%)	0 of 53 (0%)	0 of 53
Paper / Paper	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Digital	0 of 148 (0%)	0 of 148 (0%)	0 of 148

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cognitive Functioning of Healthy Individuals

Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruitingObservational study
Outdoor vs. Indoor Exercises and Cognitive Functions in Older Adults
Exercise Environment and Cognitive Performance in Older Adults
RecruitingObservational study
Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD
COPD, Health Literacy
Recruiting
Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Healthy Aging
Not yet recruitingObservational study
Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT
Hyperbaric Oxygenation, Cardiorespiratory Fitness

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 19 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 22 Jun 2023. 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?

Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Scores Digital (ISC) Tests (time frame: 1.5 hours). The study lists 4 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 NCT03801382.

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 22 Jun 2023.