Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT01044615
• Lead Sponsor: Kettering Health Network

Brief Summary

We will utilize a set of imaging modalities including computed tomography (CT), positron emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).

Detailed Description

We will recruit mTBI subjects and control subjects. Each subject will undergo the set of imaging modalities, and the results will be analyzed for differences at the structural, physiological, and molecular levels. The long term goal of this research is the development of a method to diagnose mTBI based on physical markers. This is a phased project beginning with a pilot study followed by future studies with larger sample sizes.

Study Timeline

• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Study Start: 2010-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Study group:

• Between 18 and 55 years of age inclusive.
• Potential participant verbally verifies diagnosis of mTBI at pre-screen.
• Diagnosed with mild traumatic brain injury by a VAMC physician according to standard diagnostic criteria [12],[13], to be verified by chart review.
• Less than 24 months from trauma resulting in mTBI.
• Able to read and write in English.
• Willingness to refrain from nicotine, and beverages containing either alcohol or caffeine for at least four hours prior to the imaging session.
• Have signed the consent form for the study.

Control Group:

• Between 18 and 55 years of age inclusive.
• Potential participant verbally denies history of mTBI at pre-screen.
• Able to read and write in English.
• Willingness to refrain from nicotine, and beverages containing either alcohol or caffeine for at least four hours prior to the imaging session.
• Have signed the consent form for the study

Exclusion Criteria

• Conditions that would preclude the completion of a MRI, PET, or CT exam such as claustrophobia, pacemaker, metal objects in body, and/or pregnancy.
• Serious, unstable medical or mental illness.
• Medical contraindication to any element of the study procedure.
• Have not read and signed an informed consent form, or do not understand its contents.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Kettering Health Network; 🇺🇸 Kettering, Ohio, United States