SSVEP Evaluation of Brain Function

Headsafe MFG

Status

Completed

Conditions

Mild Traumatic Brain Injury

Treatments

Device: SSVEP Device

Other: SCAT5

Study type

Observational

Funder types

Industry

Identifiers

NCT05614570

2018-10-891

Details and patient eligibility

About

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.

Enrollment

1,300 patients

Sex

All

Ages

14+ years old

Volunteers

Accepts Healthy Volunteers

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.