An observational study in Mild Traumatic Brain Injury, sponsored by Headsafe MFG. Completed at 1 site in Australia. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Headsafe MFG · Observational
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.
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
This study's enrollment of 1,300 is above the median of 177 across 151 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →Headsafe MFG is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population contained individuals 14 years or older who play sport. They were requited from a large variety of sport types and facilities including local clubs, medical centres and schools.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
Device: SSVEP Device · Other: SCAT5
This cohort contains individuals who have had a concussion, diagnosed by a doctor.
Device: SSVEP Device · Other: SCAT5
Non-invasive, non-interventional SSVEP sensor device
Also known as: Nurochek
The Sport Concussion Assessment Tool version 5
Steady State Visual Evoked Potential
A measure of the steady state visual evoked potential (SSVEP) from the device
Time frame: 30 days
SCAT5 Score
The score from the SCAT5 as determined at Step 6.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Apr 2023, 51 months.
Of 87 observational studies under Brain Concussion, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's 51 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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