Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT03515967
Status:
WITHDRAWN
Last Update Posted:
2020-06-26
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'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': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Inability to recruit', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with mTBI', 'timeFrame': '45 months', 'description': 'How many participants were detected to have mTBI following a sports-related injury'}], 'secondaryOutcomes': [{'measure': 'Time to recover', 'timeFrame': '45 months', 'description': 'Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['concussion, mild traumatic brain injury'], 'conditions': ['Brain Injuries, Traumatic']}, 'referencesModule': {'references': [{'pmid': '28894835', 'type': 'BACKGROUND', 'citation': 'Hoffer ME, Balaban C, Szczupak M, Buskirk J, Snapp H, Crawford J, Wise S, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. The use of oculomotor, vestibular, and reaction time tests to assess mild traumatic brain injury (mTBI) over time. Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):157-165. doi: 10.1002/lio2.74. eCollection 2017 Aug.'}, {'pmid': '27654131', 'type': 'BACKGROUND', 'citation': 'Balaban C, Hoffer ME, Szczupak M, Snapp H, Crawford J, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury. PLoS One. 2016 Sep 21;11(9):e0162168. doi: 10.1371/journal.pone.0162168. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).\n2. Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.\n3. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby.\n\nExclusion Criteria:\n\n1. History of brain injury resulting from a penetrating wound to the head.\n2. Presence of aphasia and/or inability to give informed consent for participation\n3. History of diagnosed neuropsychiatric disorders\n4. Documented neurodegenerative disorders\n5. Prior disorders of hearing and balance including:\n\n 1. Meniere's disease\n 2. Multiple sclerosis\n 3. Vestibular neuritis\n 4. Vestibular schwannoma\n 5. Sudden sensorineural hearing loss\n6. Cerebrovascular disorders\n7. History of ear operation other than myringotomy tube in the past\n8. Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.\n9. Presence of intra-cranial structural findings on imaging studies\n10. Prisoners"}, 'identificationModule': {'nctId': 'NCT03515967', 'briefTitle': 'Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Use of a Portable 3D Head Mounted Display With Integrated Eye Capture Technology (I-PAS) for the Objectification and Quantification of Signs and Symptoms Associated With the Diagnosis of Mild Traumatic Brain Injury (mTBI)', 'orgStudyIdInfo': {'id': '20170209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injured Athletes', 'description': 'Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles', 'interventionNames': ['Device: I-PAS Goggles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Injured Athletes', 'description': 'Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles', 'interventionNames': ['Device: I-PAS Goggles']}], 'interventions': [{'name': 'I-PAS Goggles', 'type': 'DEVICE', 'description': 'Portable, head-mounted display goggle system with integrated eye capture technology', 'armGroupLabels': ['Injured Athletes', 'Non-Injured Athletes']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Hoffer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}, {'name': 'Neurolign', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael E. Hoffer', 'investigatorAffiliation': 'University of Miami'}}}}