Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT02103803
Status:
COMPLETED
Last Update Posted:
2015-11-13
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Eye Tracking Features Following Sports-Related Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-11', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in time to complete King-Devick Test', 'timeFrame': 'Baseline to 4 weeks', 'description': "The King-Devick Test (K-D Test) is a two-minute test that requires an athlete to read single digit numbers displayed. Subjects will be seated in front of a computer screen and eye tracking device connected to the computer. The eye tracking device consists of infrared cameras, which captured eye movements by tracking the reflections of infrared reference lights on the subjects' retinas. Before the start of the experiment, they will begin by watching a moving target on the computer screen to calibrate the system. Then, the subject completes a computerized version of the K-D test. The K-D test requires that the subject rapidly read aloud the numbers presented on the three test cards. Reading the three test cards requires less than two minutes to complete. The number of errors will be counted. Oculometric data will be collected during the test and analyzed offline. The total time required to complete all three test cards is the completion time for the entire K-D test."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['concussion', 'sports-related concussion', 'mild traumatic brain injury (mTBI)', 'eye tracking', 'oculometrics'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'This proposal aims to describe the oculometric features present during King-Devick (K-D) testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.', 'detailedDescription': 'This proposal aims to describe the oculometric features present during K-D testing for subjects who experienced sports-related concussion. The investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased K-D test time. Understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.\n\nThe main objectives include:\n\n1. Describing the oculometric deficits present in subjects with acute sports-related concussion.\n2. Analyzing and quantifying the oculometric changes that occur during subject recovery.\n3. Identifying possible oculometric features as potential biomarkers that may lead to reliable, rapid method for recognizing acute concussion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty subjects with diagnosed concussion will be recruited from the adolescent and adult population seen in the Comprehensive Concussion Program at Mayo Clinic Arizona.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Over the age of 8 years, and able to provide informed consent / assent.\n* Have documented diagnosis of sports-related concussion within two weeks of the event.\n* Currently demonstrating post-concussion symptoms.\n\nExclusion criteria:\n\n\\- Alcohol consumption within 48 hours of evaluation.'}, 'identificationModule': {'nctId': 'NCT02103803', 'briefTitle': 'Assessing Eye Tracking Features Following Sports-Related Concussion', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessing Eye Tracking Features Following Sports-Related Concussion', 'orgStudyIdInfo': {'id': '13-009632'}}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Gaurav Pradhan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Jan Stepanek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Jamie Bogle, AuD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lee Family Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Consultant', 'investigatorFullName': 'Jamie M. Bogle, Au.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}