Development of a Reference Interval Database With the NeuroCatch™ Platform

Study Overview
=================
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.

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

Conditions
-----------------
Brain Health

Intervention / Treatment
-----------------
* Device: NeuroCatch™ Platform


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection and evaluation of adverse events and adverse device effects | Evaluation of safety and tolerability of the NeuroCatch™ Platform device | 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) | Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups. | 1 day |