NCT05614570 is a clinical trial of SSVEP Device in Mild Traumatic Brain Injury, sponsored by Headsafe MFG.

Who is sponsoring NCT05614570?

NCT05614570 is sponsored by Headsafe MFG.

What drugs are being tested in NCT05614570?

Interventions in NCT05614570: SSVEP Device, SCAT5.

What condition does NCT05614570 study?

NCT05614570 studies Mild Traumatic Brain Injury.

Is NCT05614570 still recruiting?

NCT05614570 is currently completed. Last updated 29 August 2023.

Last reviewed 2023-08-29 · How we verify

NCT05614570

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SSVEP Evaluation of Brain Function

Completed Last updated 29 August 2023

What this trial tests

trial testing SSVEP Device in Mild Traumatic Brain Injury in 1,300 participants. Completed in 1 April 2023.

Timeline

1 January 2019

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Headsafe MFG
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,300
Start date	1 January 2019
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	1 location across Australia

Drugs / interventions tested

SSVEP Device
SCAT5

Conditions studied

Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →

Sponsor

Headsafe MFG

Who can join

14 and older, any sex, with Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Mild Traumatic Brain Injury

Currently open trials in the same condition.

NCT07246993 — Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms · NA · recruiting
NCT07356167 — Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury · NA · recruiting
NCT07097792 — Concussion Recovery and Support Program · NA · recruiting
NCT06956417 — REhabilitation of MEMory Symptoms After BRain Concussion · NA · recruiting
NCT06217575 — Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05614570 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Headsafe MFG
Last refreshed: 29 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05614570.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing