Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury

NCT ID: NCT01044615

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mild traumatic brain injury patients

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

No interventions assigned to this group

Normal Control

Normal, healthy adults with no history of brain injury.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

Kettering Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Parker, PhD

Role: PRINCIPAL_INVESTIGATOR

Kettering Health Network

Locations

Kettering Health Network

Kettering, Ohio, United States

Countries

United States

Other Identifiers

mTBI

Identifier Type: -

Identifier Source: org_study_id