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/NCT05614570




Registration number
NCT05614570
Ethics application status
Date submitted
6/11/2022
Date registered
14/11/2022
Date last updated
29/08/2023

Titles & IDs
Public title
SSVEP Evaluation of Brain Function
Scientific title
SSVEP Evaluation of Brain Function
Secondary ID [1] 0 0
2018-10-891
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 Device
Other interventions - SCAT5

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.


Treatment: Devices: SSVEP Device
Non-invasive, non-interventional SSVEP sensor device

Other interventions: SCAT5
The Sport Concussion Assessment Tool version 5
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Steady State Visual Evoked Potential
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
SCAT5 Score
Timepoint [2] 0 0
30 days

Eligibility
Key inclusion criteria
- Individuals aged 14 years and older, participating in sport-related activities.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Individuals were excluded if they had 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2023
Sample size
Target
Accrual to date
Final
1300
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 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 website
https://clinicaltrials.gov/ct2/show/NCT05614570
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries