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SSVEP Evaluation of Brain Function

NCT05614570 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1300

Last updated 2023-08-29

No results posted yet for this study

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.

Conditions

  • Mild Traumatic Brain Injury

Interventions

DEVICE

SSVEP Device

Non-invasive, non-interventional SSVEP sensor device

OTHER

SCAT5

The Sport Concussion Assessment Tool version 5

Sponsors & Collaborators

  • Headsafe MFG

    lead INDUSTRY

Principal Investigators

  • Craig Donaldson, MBBS · Principal Investigator

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-04-01
Completion
2023-04-01
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614570 on ClinicalTrials.gov