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

NCT01075035 | Completed DMC

• 3 other identifiers: PT075832-R01A-15194IRB # 15919
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury; Post-Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results

  4 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• At least 18 years of age and non-active duty
• Either:
• Normal (no history of head injury) -OR-
• TBI (injury since Jan. 1, 2002)

You may not qualify if:

• Incapable of informed consent or absence of legally authorized representative.
• Incarcerated (or subject to court supervision).
• Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent)
• MRI incompatible (i.e. implant, metal, \> 300 lbs, severe claustrophobia)

Sponsors & Collaborators

• St. Louis University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Related Links

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

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Richard Bucholz, M.D.

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 11, 2015

Record last verified: 2014-04

Locations

US (1)