Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT04381767
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EYE-SYNC Concussion Classification Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1303}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics', 'timeFrame': '3 days', 'description': 'A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Concussion, Mild', 'Concussion; Eye', 'Concussion, Brain', 'Concussion, Severe', 'Brain Injuries', 'Concussion, Cerebral']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women actively engaged in competitive athletics\n* Eye tracking measurements and SCAT5 evaluations are collected within 3-day window\n* Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury\n\nExclusion Criteria:\n\n* Prior enrollment (subjects may only enroll once)\n* POOR eye tracking data quality\n* Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)\n* EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores \\< 2.0'}, 'identificationModule': {'nctId': 'NCT04381767', 'briefTitle': 'EYE-SYNC Concussion Classification Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sync-Think, Inc.'}, 'officialTitle': 'EYE-SYNC Concussion Classification Study', 'orgStudyIdInfo': {'id': 'EYESYNCCCV2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Concussion Evaluation', 'description': 'Adult athletes receiving a clinical evaluation for a suspected concussion after head injury', 'interventionNames': ['Device: EYE-SYNC']}], 'interventions': [{'name': 'EYE-SYNC', 'type': 'DEVICE', 'otherNames': ['SCAT-5'], 'description': 'Evaluation of oculomotor performance using visual presentation and eye tracking analysis', 'armGroupLabels': ['Concussion Evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94306', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Sync-Think, Inc.', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sync-Think, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}