Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT01298557
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2011-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D038223', 'term': 'Post-Concussion Syndrome'}], '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': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2011-02-09', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in white matter tract structure', 'timeFrame': 'up to 4 years following date of injury', 'description': 'We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI). We evaluate DTI using 3T and 7T MRI. Participants receive scans at only one time-point.'}], 'secondaryOutcomes': [{'measure': 'Neurocognitive function', 'timeFrame': 'up to 4 years following date of injury', 'description': 'We hope to better understand the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) by correlating neurocognitive testing data with imaging data. We will also compare neurocognitive testing data between patients and controls to help illustrate the impact of brain trauma on these neurocognitive symptoms. Our participants receive testing at only one time-point.'}, {'measure': 'Cortical activation', 'timeFrame': 'up to 4 years following date of injury', 'description': "We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that impaired cortical activation can be detected with magnetoencephalography (MEG). We will compare patients' data with data of controls. Our participants are scanned at only one time-point."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traumatic brain injury', 'Post-concussive symptoms', 'Brain imaging', 'Neurocognitive testing'], 'conditions': ['Traumatic Brain Injury', 'Post-concussive Symptoms']}, 'referencesModule': {'references': [{'pmid': '12006280', 'type': 'BACKGROUND', 'citation': 'Arfanakis K, Haughton VM, Carew JD, Rogers BP, Dempsey RJ, Meyerand ME. Diffusion tensor MR imaging in diffuse axonal injury. AJNR Am J Neuroradiol. 2002 May;23(5):794-802.'}, {'pmid': '15921934', 'type': 'BACKGROUND', 'citation': 'Deipolyi AR, Mukherjee P, Gill K, Henry RG, Partridge SC, Veeraraghavan S, Jin H, Lu Y, Miller SP, Ferriero DM, Vigneron DB, Barkovich AJ. Comparing microstructural and macrostructural development of the cerebral cortex in premature newborns: diffusion tensor imaging versus cortical gyration. Neuroimage. 2005 Sep;27(3):579-86. doi: 10.1016/j.neuroimage.2005.04.027.'}, {'pmid': '15846771', 'type': 'BACKGROUND', 'citation': 'Hillebrand A, Singh KD, Holliday IE, Furlong PL, Barnes GR. A new approach to neuroimaging with magnetoencephalography. Hum Brain Mapp. 2005 Jun;25(2):199-211. doi: 10.1002/hbm.20102.'}, {'pmid': '15185054', 'type': 'BACKGROUND', 'citation': 'Hughes DG, Jackson A, Mason DL, Berry E, Hollis S, Yates DW. Abnormalities on magnetic resonance imaging seen acutely following mild traumatic brain injury: correlation with neuropsychological tests and delayed recovery. Neuroradiology. 2004 Jul;46(7):550-8. doi: 10.1007/s00234-004-1227-x. Epub 2004 Jun 8.'}, {'pmid': '12544235', 'type': 'BACKGROUND', 'citation': 'Huisman TA, Sorensen AG, Hergan K, Gonzalez RG, Schaefer PW. Diffusion-weighted imaging for the evaluation of diffuse axonal injury in closed head injury. J Comput Assist Tomogr. 2003 Jan-Feb;27(1):5-11. doi: 10.1097/00004728-200301000-00002.'}]}, 'descriptionModule': {'briefSummary': 'The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited through the neurosurgery clinic at San Francisco General Hospital or referred to us by colleagues.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-50 years of age\n* single episode of blunt traumatic brain injury\n* symptoms of persistent post-concussive syndrome present an average of 4 months to 4 years since date of injury\n* fluency in English (cognitive battery not available in other languages)\n* capable of self-consent\n\nExclusion Criteria:\n\n* \\< 18 years or \\> 50 years of age\n* pregnancy\n* history of previous TBI with loss of consciousness\n* alcoholism as evidenced by Audit questionnaire\n* regular use of illicit drugs\n* non-English fluency\n* significant psychiatric history excluding mild depression or anxiety disorder any contraindication to MRI, including claustrophobia, pregnancy, any trauma or surgery which may have left ferromagnetic material in the body, ferromagnetic implants or pacemakers; and inability to lie still for 1 hour or more'}, 'identificationModule': {'nctId': 'NCT01298557', 'acronym': 'Dana-REAC', 'briefTitle': 'MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Dana-REAC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traumatic brain injured patients', 'description': 'This group consists of participants who suffered a traumatic brain injury an average of 4 months to 4 years prior to testing. Patients must not have history of prior head injury, substance abuse, psychiatric illness, or contraindications to MRI.'}, {'label': 'Controls (no traumatic brain injury)', 'description': 'This group consists of participants who do not have a history of brain trauma. Furthermore, controls must not suffer from substance abuse, psychiatric illness, or have contraindications to the MRI.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Pratik Mukherjee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Department of Radiology and Bioengineering'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}