NCT04661592

NCP 2.0 Repeat Study

Assessing Repeatability of the NeuroCatch Platform 2.0 Stimulus Sequences

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: NeuroCatch Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The NeuroCatch Platform™ version 2.0 (NCP2.0), 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 reliable and repeatable the ERP metrics elicited by the NCP platform are within participants over multiple sessions.

Detailed description

A new method for creating stimulus sequences was developed for NeuroCatch™ Platform 2.0. Rather than using a set of fixed, predetermined sequences to elicit ERPs this new method draws on a database of candidate word stimuli to generate a different, random stimulus sequence each time a scan is carried out. The goal of this is to reduce habituation to the stimulus sequences which is hypothesized to improve the repeatability of the component measurements. Characterizing how individuals respond to the stimulus sequences is an important step in the validation of the generation method itself. Understanding the degree of variability and prototypical values of each ERP component is crucial to the understanding of typical brain functioning. For this type of technology to be clinically viable in quantifying brain health, the investigators must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. This study is being carried out to assess how repeatable the ERPs elicited by the new method are while also considering the impact of intraindividual variability observed in previous investigations. Thus, by comparing the results of the scans over time, an assessment of the reliability of the new stimulus sequences can be made.

Conditions

• Brain Health

Interventions

Type	Name	Description
DEVICE	NeuroCatch Platform	To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch™ Platform version 2.0, an investigational medical device. Each sequence consists of tones and word pairs to elicit the various components of interest. Version 2.0 of the NeuroCatch™ Platform consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-03-31
• Completion: 2021-08-31
• First posted: 2020-12-10
• Last updated: 2022-03-24

Locations

1 site across 1 country: Canada