Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder (SANIC)
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|ClinicalTrials.gov Identifier: NCT01075035|
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : December 11, 2015
|Condition or disease|
|Traumatic Brain Injury Post-Traumatic Stress Disorder|
'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.
The 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.
The 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.
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Observational Model:||Case Control|
|Official Title:||Evidence Based Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder at the Saint Louis University Advanced Neurosurgical Innovation Center (SANIC)|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Normal Healthy Controls
Individuals with no history of Traumatic Brain Injury.
Civilians who have had a Traumatic Brain Injury
Combat military veterans who have had a Traumatic Brain Injury
- Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075035
|United States, Missouri|
|Saint Louis University|
|St. Louis, Missouri, United States, 63104|
|Principal Investigator:||Richard Bucholz, M.D.||St. Louis University|