NCT05614570

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4.2 years

First QC Date

November 6, 2022

Last Update Submit

August 27, 2023

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic brain injuryConcussionSteady state visual evoked potentialElectroencephalographySports ConcussionSports Medicine

Outcome Measures

Primary Outcomes (2)

  • Steady State Visual Evoked Potential

    A measure of the steady state visual evoked potential (SSVEP) from the device

    30 days

  • SCAT5 Score

    The score from the SCAT5 as determined at Step 6.

    30 days

Study Arms (2)

Baseline

This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season

Device: SSVEP DeviceOther: SCAT5

Concussed

This cohort contains individuals who have had a concussion, diagnosed by a doctor.

Device: SSVEP DeviceOther: SCAT5

Interventions

SSVEP DeviceDEVICE

Non-invasive, non-interventional SSVEP sensor device

Also known as: Nurochek
BaselineConcussed
SCAT5OTHER

The Sport Concussion Assessment Tool version 5

BaselineConcussed

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Individuals aged 14 years and older, participating in sport-related activities.

You may not qualify if:

  • Individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Headsafe

Sydney, Australia

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Craig Donaldson, MBBS

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 14, 2022

Study Start

January 1, 2019

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)