Clinical trial NCT01044615: Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury
Official title: Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Keywords: Mild Traumatic Brain Injury
Concussion
Magnetic Resonance Imaging (MRI)
Positron Emission Tomography(PET)
Computed Tomography (CT)
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2010-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Veteran's Administration Medical Center in Dayton, OH who have history of Mild Traumatic Brain Injury within 24 months prior to enrollment.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Kettering Health Network
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Jason Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References: