SSVEP Evaluation of Brain Function

August 27, 2023 updated by: Headsafe MFG

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1300

Contacts and Locations

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

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Individuals aged 14 years and older, participating in sport-related activities.

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

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 Device
Non-invasive, non-interventional SSVEP sensor device
Other Names:
  • Nurochek
Other: SCAT5
The Sport Concussion Assessment Tool version 5
Concussed
This cohort contains individuals who have had a concussion, diagnosed by a doctor.
Device: SSVEP Device
Non-invasive, non-interventional SSVEP sensor device
Other Names:
  • Nurochek
Other: SCAT5
The Sport Concussion Assessment Tool version 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steady State Visual Evoked Potential
Time Frame: 30 days
A measure of the steady state visual evoked potential (SSVEP) from the device
30 days
SCAT5 Score
Time Frame: 30 days
The score from the SCAT5 as determined at Step 6.
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, 2019

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

November 6, 2022

First Submitted That Met QC Criteria

November 6, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 27, 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

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

Yes

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.

Clinical Trials on Mild Traumatic Brain Injury

Clinical Trials on SSVEP Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe