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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
St. Louis University
ClinicalTrials.gov Identifier:
NCT01075035
First received: February 23, 2010
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Traumatic Brain Injury
Post-Traumatic Stress Disorder

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075035

Locations
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Department of Defense
Investigators
Principal Investigator: Richard Bucholz, M.D. St. Louis University
  More Information

Additional Information:
St. Louis University Home Page for the Traumatic Brain Injury Study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT01075035     History of Changes
Other Study ID Numbers: PT075832-R01, A-15194, IRB # 15919
Study First Received: February 23, 2010
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Louis University:
Traumatic Brain Injury
TBI
Military
Imaging
MEG
PET/CT
 MRI
fMRI
DTI
SANIC
veteran

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013