NCT03889483

Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Dr. Michael Esser · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

Summary

EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. The current research is primarily focused on three ERP components: the N100, P300 and N400. Each of the three ERPs have been studied in the academic laboratory for multiple decades. Through this research, a strong understanding has been developed regarding what can affect these components (e.g. task set, emotional state, etc.). However, these signals within various pediatric populations (e.g., those with persistent mTBI symptoms or multiple concussions) are not well characterized. Being able to safely and effectively employ the NeuroCatch™ Platform in a post-concussive pediatric cohort could provide researchers with the potential to elucidate the persistence of objective measures of impairment, patterns of recovery, and chronicity of problems due to mTBI in children. Secondly, understanding the degree to which these neurophysiological components fluctuate over time is crucial to the understanding of brain functioning. However, for this type of technology to be useful in quantifying brain health in this population,the degree to which a post-concussive pediatric brain naturally fluctuates in its processing capability must be quantified. NeuroCatch™ Platform has the ability to measure changes in several domains of brain function. These cognitive processes are foundational blocks for some of the highest cognitive processes: information integration and executive functioning.

Conditions

• Children, Only
• Traumatic Brain Injury
• Concussion, Mild
• Pediatric ALL

Interventions

Type	Name	Description
DEVICE	NeuroCatch™ Platform	The 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.

Timeline

• Start date: 2018-11-30
• Primary completion: 2021-09-30
• Completion: 2021-12-30
• First posted: 2019-03-26
• Last updated: 2021-01-13

Locations

1 site across 1 country: Canada