Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-02 @ 2:10 AM
Study NCT ID:
NCT02661633
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Algorithm for Likelihood of being concussed', 'timeFrame': '6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP', 'description': 'Create a database of all assessments including brain electrical activity (EEG), neurocognitive performance, balance, and clinical/symptom assessments, to support derivation of a multimodal brain function/concussion index.'}], 'secondaryOutcomes': [{'measure': 'Advanced Neuroimaging in concussion', 'timeFrame': '6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP', 'description': 'Exploration of changes in functional neuroimaging which occur with concussion and change in these measures over time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Concussion', 'Mild Traumatic Brain Injury', 'Sport Related Concussion'], 'conditions': ['Brain Injuries, Traumatic', 'Concussion, Brain', 'Concussion, Mild', 'Concussion, Intermediate', 'Concussion, Severe']}, 'referencesModule': {'references': [{'pmid': '32228157', 'type': 'DERIVED', 'citation': 'Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'This study (Part 2) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).', 'detailedDescription': 'Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 150 male and female student-athletes from participating high schools will be invited to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.\n\n 1. If loss of consciousness, total duration less than \\<20 minutes\n 2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)\n 3. No hospital admission due to either head injury or collateral injuries for \\>24 hours.\n 4. GCS between 13-15\n\nExclusion Criteria:\n\n1. Do not speak or read English\n2. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)\n3. Skull abnormalities, e.g. metal plate\n4. History of brain surgery or neurological disease\n5. Pregnant women.'}, 'identificationModule': {'nctId': 'NCT02661633', 'acronym': 'AheadCAS-HS', 'briefTitle': 'Objective Brain Function Assessment of mTBI/Concussion in High School Athletes', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrainScope Company, Inc.'}, 'officialTitle': 'Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in High School Athletes', 'orgStudyIdInfo': {'id': '16-Ahead'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Injured and Matched Control Subject Pool', 'description': 'Injured subjects consist of athletes who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, balance/sway measurement, and clinical symptoms/assessments. In addition, a subset of injured and matched control subjects will receive advanced MRI/DTI neuroimaging at time of injury and following RTP.', 'interventionNames': ['Device: BrainScope Ahead 200iD', 'Device: Advanced MRI Neuroimaging']}, {'label': 'Pre-Season and Post-Season Subject Pool', 'description': 'This subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at two time points - pre-season and post-season. These subjects will perform the same BrainScope Battery as the injured and matched control subjects at each time points.', 'interventionNames': ['Device: BrainScope Ahead 200iD']}], 'interventions': [{'name': 'BrainScope Ahead 200iD', 'type': 'DEVICE', 'description': 'The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.', 'armGroupLabels': ['Injured and Matched Control Subject Pool', 'Pre-Season and Post-Season Subject Pool']}, {'name': 'Advanced MRI Neuroimaging', 'type': 'DEVICE', 'otherNames': ['Magnetic Resonance Imaging', 'Diffusion Tension Imaging'], 'description': 'Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.', 'armGroupLabels': ['Injured and Matched Control Subject Pool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72701', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walt Whitman High School', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Leslie Prichep, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BrainScope Company, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrainScope Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}