Brain HealthNCT04661592

NCP 2.0 Repeat Study

A study testing NeuroCatch Platform in people with Brain Health, run by NeuroCatch Inc. at 1 site in Canada.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Brain Health
What is being tested?: NeuroCatch Platform
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteCanada
Study dates: 30 Nov 2020to 31 Aug 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Any sex, at least 19 years of age or older
Able to understand the informed consent form, study procedures and willing to participate in study
Able to remain seated and focused for 7 minutes
In good health with no history of clinically relevant neurological illness or injury in the last 5 years

Who cannot join

Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to earing (e.g. punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.
Implanted pacemaker or implanted electrical stimulators
Metal or plastic implants in the skull, excluding dental/facial implants
Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
Not proficient in English language
Diagnosed epilepsy or history of seizures
If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

Trial locations and contacts

1 site in 1 country.

Canada1 site

HealthTech Connex Inc. Centre for Neurology Studies
Surrey, British Columbia, V3V 0C6

Other trials in Canada

About this study

Official title: Assessing Repeatability of the NeuroCatch Platform 2.0 Stimulus Sequences

The NeuroCatch Platform™ version 2.0 (NCP2.0), an investigational medical device system developed by NeuroCatch Inc., consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP; brain response to a stimulus) information.

The purpose of the study is to understand how reliable and repeatable the ERP metrics elicited by the NCP platform are within participants over multiple sessions.

Read the detailed description

A new method for creating stimulus sequences was developed for NeuroCatch™ Platform 2.0. Rather than using a set of fixed, predetermined sequences to elicit ERPs this new method draws on a database of candidate word stimuli to generate a different, random stimulus sequence each time a scan is carried out. The goal of this is to reduce habituation to the stimulus sequences which is hypothesized to improve the repeatability of the component measurements. Characterizing how individuals respond to the stimulus sequences is an important step in the validation of the generation method itself. Understanding the degree of variability and prototypical values of each ERP component is crucial to the understanding of typical brain functioning. For this type of technology to be clinically viable in quantifying brain health, the investigators must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. This study is being carried out to assess how repeatable the ERPs elicited by the new method are while also considering the impact of intraindividual variability observed in previous investigations. Thus, by comparing the results of the scans over time, an assessment of the reliability of the new stimulus sequences can be made.

Conditions: Brain Health
Being tested: NeuroCatch Platform

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroCatch PlatformDevice
To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch™ Platform version 2.0, an investigational medical device. Each sequence consists of tones and word pairs to elicit the various components of interest. Version 2.0 of the NeuroCatch™ Platform consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)

Study groups in NCT04661592
Study group	Role	What they receive
Control	Experimental	Neurologically healthy individuals will be recruited for the longitudinal study Receives: Device: NeuroCatch Platform

What is being measured

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

Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Measured: Baseline, +1 Week, +2 Weeks
Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Measured: Baseline, +1 Week, +2 Weeks
Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Measured: Baseline, +1 Week, +2 Weeks
Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Measured: Baseline, +1 Week, +2 Weeks
Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Measured: Baseline, +1 Week, +2 Weeks
Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Measured: Baseline, +1 Week, +2 Weeks
Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Measured: Baseline, +1 Week, +2 Weeks
Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Measured: Baseline, +1 Week, +2 Weeks
Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Measured: Baseline, +1 Week, +2 Weeks
Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Measured: Baseline, +1 Week, +2 Weeks
Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Measured: Baseline, +1 Week, +2 Weeks
Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Measured: Baseline, +1 Week, +2 Weeks

Secondary outcomes (3)

Collection and evaluation of adverse events and adverse device effects
Evaluation of safety and tolerability of the NeuroCatch™ Platform device
Measured: At time of event
Change in hours of sleep of the day of scan
Secondary statistical analyses will explore the correlation between hours of sleep on the day of scan with changes in ERP measures (primary outcomes) across the sample
Measured: Baseline, +1 Week, +2 Weeks
Change in perceived mood on the day of scan
Secondary statistical analyses will explore the correlation between perceived mood (ranked on a scale of 0-100) on the day of scan with changes in ERP measures (primary outcomes) across the sample
Measured: Baseline, +1 Week, +2 Weeks

Timeline

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

30 Nov 202031 Aug 2021

First posted10 Dec 2020
Study start30 Nov 2020
Primary completion31 Mar 2021
Study completion31 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Brain HealthStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Model description: Longitudinal
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04661592
Sponsor's protocol ID: NCI_NCClin_004
Status last verified: Mar 2022
First submitted: 17 Nov 2020
Last updated: 24 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Repeatability of the NeuroCatch Platform 2.0 Stimulus Sequences
ClinicalTrials.gov ID: NCT04661592
Acronym / sponsor ID: NCI_NCClin_004
Conditions: Brain Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: NeuroCatch Inc.Industry (pharma, biotech, devices)
Study start: 30 Nov 2020 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 10 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to understand how reliable and repeatable the ERP metrics elicited by the NCP platform are within participants over multiple sessions.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Longitudinal

Arm	Type	Receives
Control	Experimental	Device: NeuroCatch PlatformNeurologically healthy individuals will be recruited for the longitudinal study

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Any sex, at least 19 years of age or older
Able to understand the informed consent form, study procedures and willing to participate in study
Able to remain seated and focused for 7 minutes
In good health with no history of clinically relevant neurological illness or injury in the last 5 years

Key exclusion criteria (8 listed)

Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to earing (e.g. punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.
Implanted pacemaker or implanted electrical stimulators
Metal or plastic implants in the skull, excluding dental/facial implants
Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
Not proficient in English language

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
NeuroCatch PlatformTo elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch™ Platform version 2.0, an investigational medical device. Each sequence consists of tones and word pairs to elicit the various components of interest. Version 2.0 of the NeuroCatch™ Platform consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)	Device	Control

Primary outcome

Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time frame: Baseline, +1 Week, +2 Weeks
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time frame: Baseline, +1 Week, +2 Weeks
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time frame: Baseline, +1 Week, +2 Weeks
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time frame: Baseline, +1 Week, +2 Weeks
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time frame: Baseline, +1 Week, +2 Weeks
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time frame: Baseline, +1 Week, +2 Weeks
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time frame: Baseline, +1 Week, +2 Weeks
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time frame: Baseline, +1 Week, +2 Weeks
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time frame: Baseline, +1 Week, +2 Weeks
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time frame: Baseline, +1 Week, +2 Weeks
Amplitude (response size) will be measured in microvolts. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points
Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
Time frame: Baseline, +1 Week, +2 Weeks
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the repeatability over three time points will be the intraclass correlation coefficient (ICC). Specifically, the two-way mixed single measures absolute agreement type of ICC (denoted as ICC(A,1)) will be used in this analysis.
Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
Time frame: Baseline, +1 Week, +2 Weeks
Latency (response speed) will be measured in milliseconds. The statistic being used to measure the variability over three time points will be the group-mean of the individual standard deviations of the measures over the three time points

3 secondary outcomes

Collection and evaluation of adverse events and adverse device effects
Time frame: At time of event
Change in hours of sleep of the day of scan
Time frame: Baseline, +1 Week, +2 Weeks
Change in perceived mood on the day of scan
Time frame: Baseline, +1 Week, +2 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
Individual participant dataSharing planned: No

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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.

Jan Venter, MD principal investigator

HealthTech Connex Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing NeuroCatch Platform in people with Brain Health, run by NeuroCatch Inc. at 1 site in Canada.

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 4 inclusion and 8 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 24 Mar 2022. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability (time frame: Baseline, +1 Week, +2 Weeks). The study lists 12 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 NCT04661592.

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 24 Mar 2022.