NCT05614570|CompletedFDA Device
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Sponsor study identifier
observational
1,300
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
April 1, 2023
Actual (reported)Study Completion
April 1, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)November 6, 2022
Actual (reported)November 14, 2022
Actual (reported)April 1, 2023
Actual (reported)April 1, 2023
Actual (reported)Steady State Visual Evoked Potential
A measure of the steady state visual evoked potential (SSVEP) from the device
30 days
SCAT5 Score
The score from the SCAT5 as determined at Step 6.
30 days
This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
This cohort contains individuals who have had a concussion, diagnosed by a doctor.
Non-invasive, non-interventional SSVEP sensor device
The Sport Concussion Assessment Tool version 5
The study population contained individuals 14 years or older who play sport. They were requited from a large variety of sport types and facilities including local clubs, medical centres and schools.
Headsafe
Sydney, Australia
Craig Donaldson, MBBS
Principal Investigator
1,300 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2022
First Posted
November 14, 2022
Study Start
January 1, 2019
Actual (reported)Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 1, 2023
Actual (reported)Study Completion
April 1, 2023
Actual (reported)Last Updated
August 29, 2023
Record last verified: 2023-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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