SSVEP Evaluation of Brain Function

Mild Traumatic Brain Injury Clinical Trial

Official title:

SSVEP Evaluation of Brain Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614570
• Other study ID #: 2018-10-891
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: Headsafe MFG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Other:
• SCAT5
The Sport Concussion Assessment Tool version 5

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	30 days
Primary	SCAT5 Score	The score from the SCAT5 as determined at Step 6.	30 days