SSVEP Evaluation of Brain Function (PRO)

Recruiting

• Conditions: Mild Traumatic Brain Injury
• Interventions: Device: SSVEP

• Registration Number: NCT06013566
• Lead Sponsor: Headsafe MFG

Brief Summary

The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), 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 computer, which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. Nurochek PRO is a development of the previously FDA cleared Nurochek System.

The primary objective of this clinical investigation was to evaluate the performance of the investigational device (NCPRO) against clinical diagnosis of 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 and 500 valid investigational device readings from healthy individuals who have had a plausible mechanism of sustaining a concussion, but do not have one. Additionally, readings from healthy individuals are also to be acquired.

The aim of this study was to collect data from 100 readings from individuals with concussion. 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 acquired from sporting clubs, medical clinicals and schools.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Individuals aged 12 years and older, participating in sport-related activities.

Exclusion Criteria

• Individuals are excluded if they have 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

Arm && Interventions

Group	Intervention	Description
Suspected Concussion	SSVEP	This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.
Baseline	SSVEP	This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
Concussed	SSVEP	This cohort contains individuals who have had a concussion, diagnosed by a doctor.

Primary Outcome Measures

Name	Time	Method
Steady State Visual Evoked Potential	5 days	A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.

Secondary Outcome Measures

Name	Time	Method
Recovery from m TBI	30 days	Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.

Trial Locations

Locations (1)

Headsafe; 🇦🇺 Sydney, Australia