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

Traumatic Brain Injury Clinical Trial

— SANIC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075035
• Other study ID #: PT075832-R01
• Secondary ID: A-15194IRB # 159
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: December 9, 2015
• Start date: August 2008
• Est. completion date: August 2014

Study information

• Verified date: April 2014
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Saint Louis University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results		4 years	No

External Links

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