SSVEP Evaluation of Brain Function (PRO)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: t
View:

• Individuals aged 12 years and older, participating in sport-related activities.

Locations
Other Locations
Australia
Headsafe
RECRUITING
Sydney
Contact Information
Primary
Dylan Mahony
research@team.headsafe.com
+61 430 411 438
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 1000
Treatments
Baseline
This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
Concussed
This cohort contains individuals who have had a concussion, diagnosed by a doctor.
Suspected Concussion
This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.
Related Therapeutic Areas
Sponsors
Leads: Headsafe MFG

This content was sourced from clinicaltrials.gov