Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-28 @ 9:56 AM
Study NCT ID:
NCT01075035
Status:
COMPLETED
Last Update Posted:
2015-12-11
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-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': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury', 'TBI', 'Military', 'Imaging', 'MEG', 'PET/CT', 'MRI', 'fMRI', 'DTI', 'SANIC', 'veteran'], 'conditions': ['Traumatic Brain Injury', 'Post-Traumatic Stress Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sites.google.com/a/slu.edu/traumatic-brain-injury-study/', 'label': 'St. Louis University Home Page for the Traumatic Brain Injury Study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are taken using three newer technologies that visualize the brain using a combination of external/internal magnetic fields and radioactive tracers (molecules that emit detectable particles). The hope is that the results of this study will validate tools (help prove that diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain injuries (TBI).', 'detailedDescription': "'Normal' appearing brain is often not normal when imaged with advanced neuroimaging techniques. It has been advocated that a battery of neurological assessments (including MEG) be developed to assess mild traumatic brain injury (TBI) and studies have shown that somatosensory evoked fields in severe TBI can serve as a measure of cortical function in comatosed TBI patients. Functional neuroimaging techniques such as PET and fMRI may reveal abnormalities in areas considered 'normal' on traditional MRI. Most significantly, advanced functional neuroimaging may enable customized neurorehabilitation planning with more efficient use of resources.\n\nThe study aim is to compare healthy brains, civilian TBI brains, and combat-related TBI to identify correlations between abnormal imaging parameters with neurorehabilitation potential utilizing advanced neurological imaging.\n\nThe study hypothesis states Severity of Traumatic Brain Injury (TBI) and Post-traumatic Stress Disorders (PTSD) can be detected and quantified using a multimodal battery of neurodiagnostic imaging techniques (MEG, PET/CT, 3 Tesla-MRI w/ DTI and fMRI) and rehabilitation potential can be predicted in the post acute phase."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50-60 Normal Healthy Controls 50-60 Civilian TBI 50-60 Military TBI', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age and non-active duty\n2. Either:\n\n 1. Normal (no history of head injury) -OR-\n 2. TBI (injury since Jan. 1, 2002)\n\nExclusion Criteria:\n\n1. Incapable of informed consent or absence of legally authorized representative.\n2. Incarcerated (or subject to court supervision).\n3. Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent)\n4. MRI incompatible (i.e. implant, metal, \\> 300 lbs, severe claustrophobia)'}, 'identificationModule': {'nctId': 'NCT01075035', 'acronym': 'SANIC', 'briefTitle': 'Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'Evidence Based Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder at the Saint Louis University Advanced Neurosurgical Innovation Center (SANIC)', 'orgStudyIdInfo': {'id': 'PT075832-R01'}, 'secondaryIdInfos': [{'id': 'A-15194', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense Study Number'}, {'id': 'IRB # 15919', 'type': 'OTHER', 'domain': 'SLU IRB #'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Healthy Controls', 'description': 'Individuals with no history of Traumatic Brain Injury.'}, {'label': 'Civilian TBI', 'description': 'Civilians who have had a Traumatic Brain Injury'}, {'label': 'Military TBI', 'description': 'Combat military veterans who have had a Traumatic Brain Injury'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Richard Bucholz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Louis University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}