Mild Traumatic Brain InjuryNCT06013566
SSVEP Evaluation of Brain Function (PRO)
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 PRO System (NCPRO), 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 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- SSVEP
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2023to Jan 2026
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: As above.
Who may be able to join
- Individuals aged 12 years and older, participating in sport-related activities.
Who cannot join
- Individuals are excluded if they have 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.
Australia1 site, 1 recruiting
- Recruiting
Headsafe
Sydney
Dylan Mahony, +61 430 411 438, dylan@team.headsafe.com
About this study
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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- SSVEP
- 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.
SSVEPDevice
Also called Nurochek PRO
Non-invasive, non-interventional SSVEP EEG device
| 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 | |
| Concussed | This cohort contains individuals who have had a concussion, diagnosed by a doctor. Receives: Device: SSVEP | |
| Suspected Concussion | This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion. Receives: Device: SSVEP |
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 and comparison with a Doctor's diagnosis.
Measured: 5 days
Secondary outcomes (1)
Recovery from m TBI
Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.
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 posted28 Aug 2023
- Study start1 Jan 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
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
- 1,000 participants (estimated)
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
- NCT06013566
- Sponsor's protocol ID
- 2018-10-891-PRO
- Status last verified
- May 2024
- First submitted
- 22 Aug 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SSVEP Evaluation of Brain Function (PRO)
- ClinicalTrials.gov ID
- NCT06013566
- Acronym / sponsor ID
- 2018-10-891-PRO
- 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
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Headsafe MFGIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 28 Aug 2023 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | Device: SSVEPThis cohort contains individuals tested at baseline, usually in the pre-season of their sporting season |
| Concussed | – | Device: SSVEPThis cohort contains individuals who have had a concussion, diagnosed by a doctor. |
| Suspected Concussion | – | Device: SSVEPThis cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As above.
Key inclusion criteria (1 listed)
- Individuals aged 12 years and older, participating in sport-related activities.
Key exclusion criteria (1 listed)
- Individuals are excluded if they have 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 |
|---|---|---|
| SSVEPAlso: Nurochek PRONon-invasive, non-interventional SSVEP EEG device | Device | Baseline, Concussed, Suspected Concussion |
Primary outcome
Steady State Visual Evoked Potential
Time frame: 5 days
A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis.
1 secondary outcome
Recovery from m TBI
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dylan Mahony (+61 430 411 438, research@team.headsafe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady State Visual Evoked Potential (time frame: 5 days). 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 16 May 2024.