SSVEP Evaluation of Brain Function

Study Overview
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Brief Summary
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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.

Official Title
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SSVEP Evaluation of Brain Function

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: SSVEP Device
* Other: SCAT5


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Baseline<br>This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season | Device: SSVEP Device<br>* Non-invasive, non-interventional SSVEP sensor device<br>* Other names: Nurochek;Other: SCAT5<br>* The Sport Concussion Assessment Tool version 5<br>|
| Concussed<br>This cohort contains individuals who have had a concussion, diagnosed by a doctor. | Device: SSVEP Device<br>* Non-invasive, non-interventional SSVEP sensor device<br>* Other names: Nurochek;Other: SCAT5<br>* The Sport Concussion Assessment Tool version 5<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Traumatic brain injury, Concussion, Steady state visual evoked potential, Electroencephalography, Sports Concussion, Sports Medicine