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

NCT ID: NCT01075035

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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'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.

Conditions

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Traumatic Brain Injury Post-Traumatic Stress Disorder

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Healthy Controls

Individuals with no history of Traumatic Brain Injury.

No interventions assigned to this group

Civilian TBI

Civilians who have had a Traumatic Brain Injury

No interventions assigned to this group

Military TBI

Combat military veterans who have had a Traumatic Brain Injury

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Bucholz, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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Saint Louis University

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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https://sites.google.com/a/slu.edu/traumatic-brain-injury-study/

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

Other Identifiers

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A-15194

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB # 15919

Identifier Type: OTHER

Identifier Source: secondary_id

PT075832-R01

Identifier Type: -

Identifier Source: org_study_id