Mild Traumatic Brain InjuryNCT05614570
SSVEP Evaluation of Brain Function
An observational study of Mild Traumatic Brain Injury, run by Headsafe MFG at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- SSVEP Device and SCAT5
- Type of treatment
- Medical device
- How many people
- 1,300 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2019to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Individuals aged 14 years and older, participating in sport-related activities.
Who cannot join
- Individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- SSVEP Device, SCAT5
- Keywords
- Mild Traumatic brain injury, Concussion, Steady state visual evoked potential, Electroencephalography, Sports Concussion, Sports Medicine
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSVEP DeviceDevice
Also called Nurochek
Non-invasive, non-interventional SSVEP sensor device
SCAT5Other
The Sport Concussion Assessment Tool version 5
| Study group | Role | What they receive |
|---|---|---|
| Baseline | This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season Receives: Device: SSVEP Device; Other: SCAT5 | |
| Concussed | This cohort contains individuals who have had a concussion, diagnosed by a doctor. Receives: Device: SSVEP Device; Other: SCAT5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady State Visual Evoked Potential
A measure of the steady state visual evoked potential (SSVEP) from the device
Measured: 30 days
SCAT5 Score
The score from the SCAT5 as determined at Step 6.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Jan 2019
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Headsafe MFG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Donaldson, MBBS, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614570
- Sponsor's protocol ID
- 2018-10-891
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SSVEP Evaluation of Brain Function
- ClinicalTrials.gov ID
- NCT05614570
- Acronym / sponsor ID
- 2018-10-891
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic brain injury, Concussion, Steady state visual evoked potential, Electroencephalography, Sports Concussion, Sports Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Headsafe MFGIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | Device: SSVEP Device, Other: SCAT5This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season |
| Concussed | – | Device: SSVEP Device, Other: SCAT5This cohort contains individuals who have had a concussion, diagnosed by a doctor. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Individuals aged 14 years and older, participating in sport-related activities.
Key exclusion criteria (1 listed)
- Individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSVEP DeviceAlso: NurochekNon-invasive, non-interventional SSVEP sensor device | Device | Baseline, Concussed |
| SCAT5The Sport Concussion Assessment Tool version 5 | Other | Baseline, Concussed |
Primary outcome
Steady State Visual Evoked Potential
Time frame: 30 days
A measure of the steady state visual evoked potential (SSVEP) from the device
SCAT5 Score
Time frame: 30 days
The score from the SCAT5 as determined at Step 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Mild Traumatic Brain Injury
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Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
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Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
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Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
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Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
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Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Donaldson, MBBS principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Headsafe MFG at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady State Visual Evoked Potential (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.