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The NeuroCatch Platformâ„¢, 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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 Platformâ„¢ device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroCatchâ„¢ Platform | Device | NeuroCatch Platformâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatchâ„¢ Platform | Response size will be measured as amplitude in microvolts. | 1 day |
| Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatchâ„¢ Platform | Response timing will be measured as latency in milliseconds. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Collection and evaluation of adverse events and adverse device effects | Evaluation of safety and tolerability of the NeuroCatchâ„¢ 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthTech Connex Centre for Neurology Studies | Surrey | British Columbia | V3V 0C6 | Canada |
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Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups. |
| 1 day |