Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-28 @ 7:30 AM
Study NCT ID:
NCT02036333
Status:
TERMINATED
Last Update Posted:
2018-02-05
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Cerebral Oximetry in Pediatric Concussion Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], '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': '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': 59}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Key Personnel Left Institution Prior to Study Completion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls.', 'timeFrame': 'At presentation (Day 0)'}], 'secondaryOutcomes': [{'measure': 'Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.', 'timeFrame': 'At presentation (Day 0)'}, {'measure': 'Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.', 'timeFrame': 'At presentation (Day 0)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['near infrared spectroscopy', 'pediatrics'], 'conditions': ['Concussion, Brain', 'Concussion, Mild', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This pilot study will employ a prospective cohort study design. Children aged 10-18 years will be recruited within the Johns Hopkins Hospital Pediatric Emergency Department (JHH PED) to participate in this study. All children must be conversant in English.', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nAll Participants\n\n* Age 10-18 years at time of visit\n\nConcussion Group\n\n* Present to JHH PED within the first 24 hours following trauma.\n* Diagnosis of concussion as defined by the 3rd International Conference on Concussion in Sport (McCrory), including the presence of any one or more of the following:\n\n 1. Symptoms (ie. headache, neck pain, nausea/vomiting, dizziness, blurred vision, balance problems, sensitive to light, sensitivity to noise, feeling slowed down, feeling in a fog, difficulty concentrating, difficulty remembering, fatigue, confusion, drowsiness, more emotional, irritability, sadness, nervous)\n 2. Physical Signs (ie. loss of consciousness, unsteadiness)\n 3. Impaired brain function (ie. confusion)\n* Glasgow Coma Score of 13-15 upon arrival to JHH PED.\n* Loss of consciousness of less than 15 minutes (if applicable).\n* No structural intracranial injuries identified on neuroimaging (if completed).\n\nEXCLUSION CRITERIA\n\nAll Participants\n\n* History of prior concussion or traumatic brain injury within preceding 6 weeks.\n* History of prior intracranial disease or mass (ie. tumor, intraventricular hemorrhage, etc.)\n* Presence of intracranial hardware.\n* Complaints of respiratory distress, tachypnea or hypoxia, which may affect regional cerebral oxygen saturation.\n* Inability to stand secondary to lower extremity disease or trauma, which is required for completion of SCAT2.\n* Inability to complete SCAT2 questionnaire secondary to developmental delay.\n* Child in foster care or legal guardian not available.\n* Participant known to be pregnant, which alters total body blood flow and likely affects regional cerebral oxygen saturation.\n* Non-English speaking.'}, 'identificationModule': {'nctId': 'NCT02036333', 'briefTitle': 'The Role of Cerebral Oximetry in Pediatric Concussion Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'The Role of Cerebral Oximetry in Pediatric Concussion Assessment', 'orgStudyIdInfo': {'id': 'NA_00078909'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Concussion Group'}, {'label': 'Control Group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University Pediatric Emergency Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jennifer Anders, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}