SSVEP Evaluation of Brain Function (PRO)

Mild Traumatic Brain Injury Clinical Trial

Official title:

SSVEP Evaluation of Brain Function (PRO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013566
• Other study ID #: 2018-10-891-PRO
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Headsafe MFG
• Contact: Dylan Mahony
• Phone: +61 430 411 438
• Email: research[@]team.headsafe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Device:
• SSVEP
Non-invasive, non-interventional SSVEP EEG device

Locations

Country	Name	City	State
Australia	Headsafe	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Headsafe MFG

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady State Visual Evoked Potential	A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.	5 days
Secondary	Recovery from m TBI	Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.	30 days