NCT03835962

Brief Summary

The NeuroCatch Platform™, 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 the brain responds to sounds and words, and how this response varies between individuals of different age groups. Interindividual variation reflects the many different factors which cause results to vary from one individual to another within a population. The current clinical study aims to establish a reference interval database of ERPs. These reference intervals will characterize the expected range of interindividual variability between groups. Reference interval databases provide a tool for comparing the results from one individual with those from other members of the same age group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

February 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

February 7, 2019

Last Update Submit

March 16, 2021

Conditions

Brain Health

Outcome Measures

Primary Outcomes (2)

  • Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform

    Response size will be measured as amplitude in microvolts.

    1 day

  • Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform

    Response timing will be measured as latency in milliseconds.

    1 day

Secondary Outcomes (2)

  • Collection and evaluation of adverse events and adverse device effects

    1 day

  • Demographic indicators (date of birth, sex, level of education, recent sleep, average sleep, fatigue level, recent exercise, recent diet, handedness, first language, medical history, neurological status, and profession)

    1 day

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All participants will be asked to attend one experimental session. During the session, participants will listen one auditory stimulus sequence including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device.

Device: NeuroCatch™ Platform

Interventions

NeuroCatch™ PlatformDEVICE

NeuroCatch Platform™ 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) information.

Intervention Arm

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any sex, at least 8 years of age or older
  • Able to understand the informed consent/assent form, study procedures and willing to participate in study
  • Able to remain seated and focused for 6 minutes
  • Normal hearing capabilities

You may not qualify if:

  • Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
  • Implanted pacemaker or implanted electrical stimulators
  • Metal or plastic implants in skull
  • 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
  • Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
  • If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
  • History of seizures
  • Allergy to rubbing alcohol or EEG gel
  • 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 Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

Study Design

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

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 11, 2019

Study Start

March 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

CA(1)