Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-01 @ 10:33 PM
Study NCT ID:
NCT06013566
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSVEP Evaluation of Brain Function (PRO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady State Visual Evoked Potential', 'timeFrame': '5 days', 'description': "A measure of the steady state visual evoked potential (SSVEP) from the device and comparison with a Doctor's diagnosis."}], 'secondaryOutcomes': [{'measure': 'Recovery from m TBI', 'timeFrame': '30 days', 'description': 'Follow up testing with the investigational device to examine of there is a link between mTBI recovery and investigational device recordings of brain activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Traumatic brain injury', 'Concussion', 'Steady state visual evoked potential', 'Electroencephalography', 'Sports Concussion', 'Sports Medicine'], 'conditions': ['Mild Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'As above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 12 years and older, participating in sport-related activities.\n\nExclusion Criteria:\n\n* Individuals are excluded if they have a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.'}, 'identificationModule': {'nctId': 'NCT06013566', 'briefTitle': 'SSVEP Evaluation of Brain Function (PRO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Headsafe MFG'}, 'officialTitle': 'SSVEP Evaluation of Brain Function (PRO)', 'orgStudyIdInfo': {'id': '2018-10-891-PRO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Baseline', 'description': 'This cohort contains individuals tested at baseline, usually in the pre-season of their sporting season', 'interventionNames': ['Device: SSVEP']}, {'label': 'Concussed', 'description': 'This cohort contains individuals who have had a concussion, diagnosed by a doctor.', 'interventionNames': ['Device: SSVEP']}, {'label': 'Suspected Concussion', 'description': 'This cohort contains individuals suspected of having a concussion, but were cleared by a medical professional and do not have a concussion.', 'interventionNames': ['Device: SSVEP']}], 'interventions': [{'name': 'SSVEP', 'type': 'DEVICE', 'otherNames': ['Nurochek PRO'], 'description': 'Non-invasive, non-interventional SSVEP EEG device', 'armGroupLabels': ['Baseline', 'Concussed', 'Suspected Concussion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dylan Mahony', 'role': 'CONTACT', 'email': 'dylan@team.headsafe.com', 'phone': '+61 430 411 438'}], 'facility': 'Headsafe', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Dylan Mahony', 'role': 'CONTACT', 'email': 'research@team.headsafe.com', 'phone': '+61 430 411 438'}], 'overallOfficials': [{'name': 'Craig Donaldson, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Headsafe MFG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}