Development of a Reference Interval Database With the NeuroCatch™ Platform
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|ClinicalTrials.gov Identifier: NCT03835962|
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : April 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Health||Device: NeuroCatch™ Platform||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||March 1, 2024|
Experimental: 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.
Device: NeuroCatch™ 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.
- 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.
- Collection and evaluation of adverse events and adverse device effects [ Time Frame: 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) [ Time Frame: 1 day ]Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835962
|Contact: Christopher Smithfirstname.lastname@example.org|
|Canada, British Columbia|
|HealthTech Connex Centre for Neurology Studies||Recruiting|
|Surrey, British Columbia, Canada, V3V 0C6|
|Contact: Gabriela Pawlowski email@example.com|
|Principal Investigator: Jan Venter, MD|