Clinical trial NCT03835962: Development of a Reference Interval Database With the NeuroCatch™ Platform
Official title: Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Health
Lead sponsor: NeuroCatch Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 135
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
timeFrame: 1 day
measure: Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
timeFrame: 1 day
Secondary outcomes:
measure: Collection and evaluation of adverse events and adverse device effects
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: HealthTech Connex Centre for Neurology Studies
state: British Columbia
Study officials:
References: