SSVEP Evaluation of Brain Function

Sponsor

Headsafe MFG (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05614570

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Traumatic Brain Injury	Device: SSVEP Device Other: SCAT5

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

SSVEP Evaluation of Brain Function

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Baseline

This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season

Device: SSVEP Device

Non-invasive, non-interventional SSVEP sensor device

Other Names:

Nurochek

Other: SCAT5

The Sport Concussion Assessment Tool version 5

Concussed

This cohort contains individuals who have had a concussion, diagnosed by a doctor.

Device: SSVEP Device

Non-invasive, non-interventional SSVEP sensor device

Other Names:

Nurochek

Other: SCAT5

The Sport Concussion Assessment Tool version 5

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.