ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06013566

Registration number

NCT06013566

Ethics application status

Date submitted

22/08/2023

Date registered

28/08/2023

Titles & IDs

Public title

SSVEP Evaluation of Brain Function (PRO)

Scientific title

SSVEP Evaluation of Brain Function (PRO)

Secondary ID [1]

2018-10-891-PRO

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild Traumatic Brain Injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Treatment: Devices - SSVEP

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.

Treatment: Devices: SSVEP
Non-invasive, non-interventional SSVEP EEG device

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Steady State Visual Evoked Potential

Timepoint [1]

5 days

Secondary outcome [1]

Recovery from m TBI

Timepoint [1]

30 days

Eligibility

Key inclusion criteria

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

Minimum age

12 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2023

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/01/2026

Actual

Sample size

Target

1000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Headsafe - Sydney

Recruitment postcode(s) [1]

- Sydney

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Headsafe MFG

Address

Country

Ethics approval

Ethics application status

Summary

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 website

https://clinicaltrials.gov/study/NCT06013566

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Craig Donaldson, MBBS

Address

Principal Investigator

Country

Phone

Fax

Contact person for public queries

Name

Dylan Mahony

Address

Country

Phone

+61 430 411 438

Fax

research@team.headsafe.com

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06013566

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06013566