Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

— mTBI  

Official title:

Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044615
• Other study ID #: mTBI
• Status: Completed
• Phase: N/A
• First received: January 6, 2010
• Last updated: January 10, 2013
• Start date: December 2010

Study information

• Verified date: January 2013
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Mild Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Kettering Health Network	Kettering	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kettering Health Network	University of Cincinnati

Country where clinical trial is conducted

United States,