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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01075035

Acronym

SANIC

Enrollment

224

Registered

2010-02-24

Start date

2008-08-31

Completion date

2014-08-31

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder, Traumatic Brain Injury

Keywords

Traumatic Brain Injury, TBI, Military, Imaging, MEG, PET/CT, MRI, fMRI, DTI, SANIC, veteran

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).

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

United States

Outcome results