SSVEP Evaluation of Brain Function

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT05614570
• Lead Sponsor: Headsafe MFG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-14
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

• Individuals aged 14 years and older, participating in sport-related activities.

Exclusion Criteria

• Individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SCAT5 Score	30 days	The score from the SCAT5 as determined at Step 6.
Steady State Visual Evoked Potential	30 days	A measure of the steady state visual evoked potential (SSVEP) from the device

Trial Locations

Locations (1)

Headsafe; 🇦🇺 Sydney, Australia