Evaluation of brain function using a portable EEG headset
SSVEP Evaluation of Brain Function (PRO)
Headsafe MFG · NCT06013566
This study is testing a new portable EEG headset to see if it can help detect concussions in young athletes by measuring their brain responses while they play sports.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Headsafe MFG (industry) |
| Locations | 1 site (Sydney) |
| Trial ID | NCT06013566 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the performance of the Nurochek PRO System, a portable electroencephalogram (EEG) headset designed to assess mild traumatic brain injury (mTBI) through visual-evoked potentials (VEP). Participants, aged 12 and older, engage in sport-related activities while the device measures their brain responses to visual stimuli. The data collected is securely transmitted to a cloud server for analysis, aiming to establish the device's effectiveness in detecting concussions compared to clinical diagnoses. The study seeks to gather readings from both individuals with concussions and healthy participants to validate the device's performance.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 years and older who are involved in sports and may have experienced a concussion.
Not a fit: Patients with a history of seizures, epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a rapid and reliable method for diagnosing mild traumatic brain injuries in athletes.
How similar studies have performed: While this approach is innovative, similar studies using EEG technology for concussion detection have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sydney
- Headsafe — Sydney, Australia (RECRUITING)
Study contacts
- Principal investigator: Craig Donaldson, MBBS — Principal Investigator
- Study coordinator: Dylan Mahony
- Email: research@team.headsafe.com
- Phone: +61 430 411 438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Traumatic Brain Injury, Mild Traumatic brain injury, Concussion, Steady state visual evoked potential, Electroencephalography, Sports Concussion, Sports Medicine