Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT04837066
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2021-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Vision Testing and Concussion Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-Condition BESS', 'timeFrame': 'August 15, 2021 - August 15, 2024', 'description': 'Number of errors and time subject was able to hold position'}, {'measure': 'Gaze Stabilization Test (GST)', 'timeFrame': 'August 15, 2021 - August 15, 2024', 'description': 'Maximum head velocity in degrees/second'}, {'measure': 'Dynamic Visual Acuity (DVA)', 'timeFrame': 'August 15, 2021 - August 15, 2024', 'description': 'Log of minimal angle resolvable units (LogMAR). The number of lines on an eye chart that are lost with head moving (DVA) compared to the head steady condition, known as static visual acuity (SVA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head Injury', 'Sport Injury', 'Concussion, Brain']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.", 'detailedDescription': 'The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN\'s established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Due to COVID-19 and the uncertainty of which teams will be competing during the academic year, our subject pool will potentially come from any athlete who provides consent from an equal number of men's and women's teams who are competing that semester.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* California State University Northridge athletes\n* Participants are able to give consent to participate in the study\n* Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team\n* Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.\n* Sampling of convenience on a volunteer basis\n\nExclusion Criteria:\n\n* Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.\n* The initial 6- condition BESS score is \\>20 errors\n* The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.'}, 'identificationModule': {'nctId': 'NCT04837066', 'briefTitle': 'Dynamic Vision Testing and Concussion Management', 'organization': {'class': 'OTHER', 'fullName': 'California State University, Northridge'}, 'officialTitle': 'Dynamic Vision Testing and Concussion Management', 'orgStudyIdInfo': {'id': 'IRB-FY20-339'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a sports-related concussion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91330-8411', 'city': 'Northridge', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aimie Kachingwe, Dr.', 'role': 'CONTACT', 'email': 'aimie.kachingwe@csun.edu', 'phone': '818-677-4684'}], 'facility': 'California State University, Northridge, Jacaranda Hall 1578, 1576, 1574', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}], 'centralContacts': [{'name': 'Aimie Kachingwe, Dr.', 'role': 'CONTACT', 'email': 'aimie.kachingwe@csun.edu', 'phone': '818-677-4684'}, {'name': 'Margaret Roller, Dr.', 'role': 'CONTACT', 'email': 'peggy.roller@csun.edu', 'phone': '818-677-4684'}], 'overallOfficials': [{'name': 'Aimie Kachingwe, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSUN'}, {'name': 'Margaret Roller, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSUN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California State University, Northridge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Aimie Kachingwe', 'investigatorAffiliation': 'California State University, Northridge'}}}}