Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06013566




Registration number
NCT06013566
Ethics application status
Date submitted
22/08/2023
Date registered
28/08/2023
Date last updated
16/05/2024

Titles & IDs
Public title
SSVEP Evaluation of Brain Function (PRO)
Scientific title
SSVEP Evaluation of Brain Function (PRO)
Secondary ID [1] 0 0
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 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
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] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Steady State Visual Evoked Potential
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
Recovery from m TBI
Timepoint [1] 0 0
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] 0 0
Headsafe - Sydney
Recruitment postcode(s) [1] 0 0
- 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/ct2/show/NCT06013566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Donaldson, MBBS
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dylan Mahony
Address 0 0
Country 0 0
Phone 0 0
+61 430 411 438
Fax 0 0
Email 0 0
research@team.headsafe.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06013566