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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)
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Scientific title
SSVEP Evaluation of Brain Function (PRO)
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Secondary ID [1]
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2018-10-891-PRO
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury
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Condition category
Condition code
Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Steady State Visual Evoked Potential
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Assessment method [1]
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A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.
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Timepoint [1]
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5 days
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Secondary outcome [1]
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Recovery from m TBI
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Assessment method [1]
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Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.
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Timepoint [1]
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30 days
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Eligibility
Key inclusion criteria
- Individuals aged 12 years and older, participating in sport-related activities.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2026
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Headsafe - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Headsafe MFG
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06013566
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Craig Donaldson, MBBS
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Address
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Principal Investigator
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dylan Mahony
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Address
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Country
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Phone
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+61 430 411 438
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06013566
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