Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury (mTBI)

Kettering Health Network

Status: Completed

Conditions: Mild Traumatic Brain Injury

Study type: Observational

Funder types: Other

Identifiers

NCT01044615

mTBI

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Mild traumatic brain injury patients

Description:

Subjects who have a verifiable diagnosis of mild traumatic brain injury sustained within 24 months prior to enrollment

Normal Control

Description:

Normal, healthy adults with no history of brain injury.