NCT06013566 SSVEP Evaluation of Brain Function (PRO)
| NCT ID | NCT06013566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Headsafe MFG |
| Condition | Mild Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-01-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Craig Donaldson, MBBS
PRINCIPAL INVESTIGATOR
Principal Investigator
Frequently Asked Questions
Who can join the NCT06013566 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06013566 currently recruiting?
Yes, NCT06013566 is actively recruiting participants. Contact the research team at research@team.headsafe.com for enrollment information.
Where is the NCT06013566 trial being conducted?
This trial is being conducted at Sydney, Australia.
Who is sponsoring the NCT06013566 clinical trial?
NCT06013566 is sponsored by Headsafe MFG. The principal investigator is Craig Donaldson, MBBS at Principal Investigator. The trial plans to enroll 1,000 participants.