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

Evidence Based Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder at the Saint Louis University Advanced Neurosurgical Innovation Center (SANIC)

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).

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

50-60 Normal Healthy Controls 50-60 Civilian TBI 50-60 Military TBI

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results	4 years

Collaborators and Investigators

• Sponsor: St. Louis University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Richard Bucholz, M.D., St. Louis University

Publications and helpful links

Helpful Links

• St. Louis University Home Page for the Traumatic Brain Injury Study

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: MRI; Imaging; PET/CT; fMRI; veteran; TBI; MEG; DTI; Military; Traumatic Brain Injury; SANIC
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: PT075832-R01; A-15194 (Other Grant/Funding Number: Department of Defense Study Number); IRB # 15919 (Other Identifier: SLU IRB #)