Brain Health
Conditions
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.
Interventions
DEVICENeuroCatch™ 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.
Sponsors
NeuroCatch Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform | 1 day | Response size will be measured as amplitude in microvolts. |
| Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform | 1 day | Response timing will be measured as latency in milliseconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection and evaluation of adverse events and adverse device effects | 1 day | Evaluation of safety and tolerability of the NeuroCatch™ Platform device |
| 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 | Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups. |
Countries
Canada
Outcome results
None listed