Development of a Reference Interval Database With the NeuroCatch™ Platform

NCT ID: NCT03835962

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Arm

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.

Group Type EXPERIMENTAL

NeuroCatch™ Platform

Intervention Type DEVICE

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.

Interventions

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NeuroCatch™ Platform

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 Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
2. Implanted pacemaker or implanted electrical stimulators
3. Metal or plastic implants in skull
4. 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
5. Not proficient in English language
6. Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
7. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
8. History of seizures
9. Allergy to rubbing alcohol or EEG gel
10. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NeuroCatch Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HealthTech Connex Centre for Neurology Studies

Surrey, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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NCI_NCClin_002

Identifier Type: -

Identifier Source: org_study_id

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