NCT05614570

SSVEP Evaluation of Brain Function

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (actual)
• Sponsor: Headsafe MFG · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

The investigational device used in this clinical investigation, the Nurochek Headset, is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a smartphone which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. The primary objective of this clinical investigation was to evaluate the performance of the investigation device (NCII) against clinical diagnosis and SCAT 5, in the accurate detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion The aim of this study was to collect data from 100 readings from individuals with concussion. It was estimate that approximately 10-20% of baselined players would suffer a concussion during the season. There it was estimated there would be a need to baseline 500-1000 individuals in order to achieve the number of concussions required. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were required from sporting clubs, medical clinicals and schools.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	SSVEP Device	Non-invasive, non-interventional SSVEP sensor device
OTHER	SCAT5	The Sport Concussion Assessment Tool version 5

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2022-11-14
• Last updated: 2023-08-29

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study