Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-29 @ 11:13 PM
Study NCT ID:
NCT05771051
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2023-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Australian University of California San Francisco (UCSF) Concussion in Athletes (AUSSIE-2)
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': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of model for the detection of concussion', 'timeFrame': '1 month', 'description': 'Sensitivity of headpulse measurements confirming concussion'}], 'secondaryOutcomes': [{'measure': 'Time to recovery of headpulse following concussion', 'timeFrame': '1 Month', 'description': 'Time (hours) when the headpulse biometric returns to within 1 SD of normal values'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['headpulse', 'mTBI'], 'conditions': ['Concussion, Mild']}, 'descriptionModule': {'briefSummary': 'Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.', 'detailedDescription': 'Recently concussed athletes will have headpulse measurements obtained as soon after the clinically identified concussion as is feasible and at 1-3 day intervals over the course of a month. These recordings will pair with a self administered neurological symptom inventory (NSI) to track the athletes subjective concussion symptoms. Data from the prior study (AUSSIE-1) will be used to confirm the predictive value of the established algorithm'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recently concussed athletes playing Australian rules football. Controls are athletes of Australian Football or other sports without concussion for more than 1 year.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Concussion Subjects:\n\nInclusion Criteria:\n\n* Diagnosed with sport related concussion\n* first recording obtained within one week\n* willingness to have multiple recordings in the month following concussion\n\nExclusions:\n\n\\- head laceration\n\nControl subjects:\n\nInclusion Criteria\n\n* athletes without concussion over the last year\n* willingness to have single or multiple recordings\n\nExclusion Criteria:\n\n* head laceration'}, 'identificationModule': {'nctId': 'NCT05771051', 'acronym': 'AUSSIE-2', 'briefTitle': 'Australian University of California San Francisco (UCSF) Concussion in Athletes (AUSSIE-2)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2', 'orgStudyIdInfo': {'id': '1573'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Concussed', 'description': 'Diagnosis of concussion', 'interventionNames': ['Device: Headpulse measurements']}, {'label': 'Controls', 'description': 'Athletes with no concussion with the preceding year', 'interventionNames': ['Device: Headpulse measurements']}], 'interventions': [{'name': 'Headpulse measurements', 'type': 'DEVICE', 'otherNames': ['Wrist accelerometer'], 'description': 'Placement of headset on subject', 'armGroupLabels': ['Concussed', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Wade S Smith, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}