NCT04661592

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

November 17, 2020

Last Update Submit

March 22, 2022

Conditions

Brain Health

Outcome Measures

Primary Outcomes (12)

  • 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.

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    Baseline, +1 Week, +2 Weeks

Secondary Outcomes (3)

  • Collection and evaluation of adverse events and adverse device effects

    At time of event

  • Change in hours of sleep of the day of scan

    Baseline, +1 Week, +2 Weeks

  • Change in perceived mood on the day of scan

    Baseline, +1 Week, +2 Weeks

Study Arms (1)

Control

EXPERIMENTAL

Neurologically healthy individuals will be recruited for the longitudinal study

Device: NeuroCatch Platform

Interventions

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)

Control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthTech Connex Inc. Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

Study Officials

  • Jan Venter, MD

    HealthTech Connex Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Longitudinal
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

December 10, 2020

Study Start

November 30, 2020

Primary Completion

March 31, 2021

Study Completion

August 31, 2021

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)