Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1000 participants
OBSERVATIONAL
2023-01-01
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Wireless EEG Patch for Continuous Electrographic Monitoring
NCT03583957
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
NCT07044596
Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project
NCT05057156
Assessing the Impact of the NeuroCatch Platform 2 Stimulus Tone Volume
NCT04956172
Subcortical Arousal in Perceptual Awareness
NCT06934356
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Baseline
This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season
SSVEP
Non-invasive, non-interventional SSVEP EEG device
Concussed
This cohort contains individuals who have had a concussion, diagnosed by a doctor.
SSVEP
Non-invasive, non-interventional SSVEP EEG device
Suspected Concussion
This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.
SSVEP
Non-invasive, non-interventional SSVEP EEG device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SSVEP
Non-invasive, non-interventional SSVEP EEG device
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Headsafe MFG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Craig Donaldson, MBBS
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Headsafe
Sydney, , Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-10-891-PRO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.