Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NeuroCatch Inc.
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Response size of selected ERPs (N100, P300, N400) acquired using 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: NeuroCatch™ Platform (Device)
Outcomes
Primary Outcomes
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.
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
- 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)