Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-13 @ 9:32 AM
Study NCT ID:
NCT00580918
Status:
WITHDRAWN
Last Update Posted:
2021-01-25
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Nonapplicable clinical trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI scans', 'timeFrame': 'three to four years post injury'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mild Traumatic Brain Injury', 'fMRI'], 'conditions': ['Mild Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to assess the attentional ability of patients with mild to moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI) technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of activation with those of normal controls to see if there is a failure to activate frontal lobes in the traumatic brain injured subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mild Traumatic Brain Injury Normal health controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate brain injury patients referred to the UCI Brain Imaging Center.\n\n * Mild brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 13-15.\n * Moderate brain injury brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 9-12 .\n* Normal healthy control subjects (20)\n\nExclusion Criteria:\n\n* Pre-accident neuropathology, psychopathology, or secondary neuropathological complications, or chemical abuse\n* Patients who required intracranial surgical intervention\n* Children, pregnant women, or institutionalized individuals unable to freely give consent\n* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material\n* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities\n* Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported)\n* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion\n* Patients with implanted prosthetic heart valves\n* Patients with pacemakers, neuro-stimulation devices\n* Subjects who have severe claustrophobia.'}, 'identificationModule': {'nctId': 'NCT00580918', 'briefTitle': 'Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients', 'orgStudyIdInfo': {'id': 'HS#2003-3139'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Mild Traumatic Brain Injury group', 'interventionNames': ['Other: functional magnetic resonance imaging fMRI']}, {'label': '2', 'description': 'Normal healthy control group', 'interventionNames': ['Other: functional magnetic resonance imaging fMRI']}], 'interventions': [{'name': 'functional magnetic resonance imaging fMRI', 'type': 'OTHER', 'description': 'functional magnetic resonance imaging fMRI', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Joseph C Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}