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Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder (SANIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01075035
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : December 11, 2015
United States Department of Defense
Information provided by (Responsible Party):
St. Louis University

Brief Summary:
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).

Condition or disease
Traumatic Brain Injury Post-Traumatic Stress Disorder

Detailed Description:

'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.

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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Normal Healthy Controls
Individuals with no history of Traumatic Brain Injury.
Civilian TBI
Civilians who have had a Traumatic Brain Injury
Military TBI
Combat military veterans who have had a Traumatic Brain Injury

Primary Outcome Measures :
  1. Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results [ Time Frame: 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
50-60 Normal Healthy Controls 50-60 Civilian TBI 50-60 Military TBI

Inclusion Criteria:

  1. At least 18 years of age and non-active duty
  2. Either:

    1. Normal (no history of head injury) -OR-
    2. TBI (injury since Jan. 1, 2002)

Exclusion Criteria:

  1. Incapable of informed consent or absence of legally authorized representative.
  2. Incarcerated (or subject to court supervision).
  3. Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent)
  4. MRI incompatible (i.e. implant, metal, > 300 lbs, severe claustrophobia)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01075035

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United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
United States Department of Defense
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Principal Investigator: Richard Bucholz, M.D. St. Louis University
Additional Information:
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Responsible Party: St. Louis University Identifier: NCT01075035    
Other Study ID Numbers: PT075832-R01
A-15194 ( Other Grant/Funding Number: Department of Defense Study Number )
IRB # 15919 ( Other Identifier: SLU IRB # )
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: April 2014
Keywords provided by St. Louis University:
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Trauma and Stressor Related Disorders
Mental Disorders