NCT06013566

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

August 22, 2023

Last Update Submit

May 15, 2024

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic brain injuryConcussionSteady state visual evoked potentialElectroencephalographySports ConcussionSports Medicine

Outcome Measures

Primary Outcomes (1)

  • Steady State Visual Evoked Potential

    A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.

    5 days

Secondary Outcomes (1)

  • Recovery from m TBI

    30 days

Study Arms (3)

Baseline

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

Device: SSVEP

Concussed

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

Device: SSVEP

Suspected Concussion

This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.

Device: SSVEP

Interventions

SSVEPDEVICE

Non-invasive, non-interventional SSVEP EEG device

Also known as: Nurochek PRO
BaselineConcussedSuspected Concussion

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

As above.

You may qualify if:

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

You may not qualify if:

  • Individuals are excluded if they have 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

RECRUITING

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

Central Study Contacts

Dylan Mahony

CONTACT

+61 430 411 438research@team.headsafe.com

Study Design

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

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)