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OpenTrials
Completed

NCT Number: NCT03835962

Development of a Reference Interval Database With the NeuroCatch™ Platform

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.

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Key information

Conditions

Brain Health

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthTech Connex Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

NeuroCatch™ Platform

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.

Primary outcomes

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

    Time frame: 1 day

    Response size will be measured as amplitude in microvolts.

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

    Time frame: 1 day

    Response timing will be measured as latency in milliseconds.

Secondary outcomes

  1. Collection and evaluation of adverse events and adverse device effects

    Time frame: 1 day

    Evaluation of safety and tolerability of the NeuroCatch™ Platform device

  2. 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)

    Time frame: 1 day

    Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups.

Sponsors and collaborators

Lead sponsor

NeuroCatch Inc.

Industry

Registry information

Official study title

Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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