Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 11:58 PM
Study NCT ID:
NCT02754206
Status:
TERMINATED
Last Update Posted:
2021-09-14
First Post:
2016-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Blood Flow Regulation and Concussions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D038223', 'term': 'Post-Concussion Syndrome'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'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': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI left university and IRB protocol closed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-04-25', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral blood flow regulation', 'timeFrame': 'Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion', 'description': "Subject's cerebral blood flow regulation (cm/sec) at rest, during a cognitive test, and during a breathing test will be measured."}], 'secondaryOutcomes': [{'measure': 'Blood Biomarkers', 'timeFrame': 'Control, 3 days post concussion, 21 days post concussion, 3 months post concussion', 'description': 'Subjects will have their blood drawn so investigators can look at biomarkers in their blood. The biomarkers will be Tau, a-Spectrin N-Terminal Fragment, Neuron-specific enolase, Ubiquitin C-Terminal hydrolase L1, S100B, and Glial fibrillary acidic protein.'}, {'measure': 'Memory Function Test', 'timeFrame': 'Control, 3 days post concussion, 21 days post concussion, 3 months post concussion', 'description': 'Subjects will be given paper tests to test their memory function.'}, {'measure': 'Balance Test', 'timeFrame': 'Control, 3 days post concussion, 21 days post concussion, 3 months post concussion', 'description': 'Subjects balance will be measured using a force plate.'}, {'measure': 'Orthostatic Tolerance Test', 'timeFrame': 'Control, 3 days post concussion, 21 days post concussion, 3 months post concussion', 'description': 'Subjects physiological measurements will be measured as the move from a seated position to a standing position.'}, {'measure': 'Cerebral Vasoreactivity', 'timeFrame': 'Control, 3 days post concussion, 21 days post concussion, 3 months post concussion', 'description': 'Subjects will breathe normal air, a 8% carbon dioxide gas mixture, and hyperventilate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Concussion', 'Post-Concussion Syndrome']}, 'referencesModule': {'references': [{'pmid': '30729729', 'type': 'DERIVED', 'citation': 'Purkayastha S, Adair H, Woodruff A, Ryan LJ, Williams B, James E, Bell KR. Balance Testing Following Concussion: Postural Sway versus Complexity Index. PM R. 2019 Nov;11(11):1184-1192. doi: 10.1002/pmrj.12129. Epub 2019 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.', 'detailedDescription': 'Comparisons will be made between control data and data following a concussion collected from athletes participating in contact-collision sports. For those suffering a concussion, comparisons will be made between day 3 (acute phase), day 21 (recovery phase), and 3 months post-concussion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Collegiate Athletes who are currently playing a contact-collision sport.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Participants who are unable to play as a result of injury. Presence of irregular heart beat.'}, 'identificationModule': {'nctId': 'NCT02754206', 'briefTitle': 'Cerebral Blood Flow Regulation and Concussions', 'organization': {'class': 'OTHER', 'fullName': 'Southern Methodist University'}, 'officialTitle': 'Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion', 'orgStudyIdInfo': {'id': 'SouthernMethodist'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Subjects who are collegiate level athletes who do not have a concussion and are currently playing a contact-collision sport.'}, {'label': 'Concussed', 'description': 'Subjects who have recently suffered a sports-related concussion and are currently a collegiate athlete playing a contact-collision sport.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75205', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southern Methodist University', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Sushmita Purkayastha, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Methodist University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Methodist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research Compliance', 'investigatorFullName': 'Heather McClary', 'investigatorAffiliation': 'Southern Methodist University'}}}}