SSVEP Evaluation of Brain Function (PRO)

August 22, 2023 updated by: Headsafe MFG

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

As above.

Description

Inclusion Criteria:

  • Individuals aged 12 years and older, participating in sport-related activities.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Baseline
This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
Device: SSVEP
Non-invasive, non-interventional SSVEP EEG device
Other Names:
  • Nurochek PRO
Concussed
This cohort contains individuals who have had a concussion, diagnosed by a doctor.
Device: SSVEP
Non-invasive, non-interventional SSVEP EEG device
Other Names:
  • Nurochek PRO
Suspected Concussion
This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.
Device: SSVEP
Non-invasive, non-interventional SSVEP EEG device
Other Names:
  • Nurochek PRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery from m TBI
Time Frame: 30 days
Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Headsafe MFG

Investigators

  • Principal Investigator: Craig Donaldson, MBBS, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-10-891-PRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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