Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury (mTBI)
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Purpose
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).
| Condition |
|---|
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Mild Traumatic Brain Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Groups/Cohorts |
|---|
|
Mild traumatic brain injury patients
Subjects who have a verifiable diagnosis of mild traumatic brain injury sustained within 24 months prior to enrollment
|
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Normal Control
Normal, healthy adults with no history of brain injury.
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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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients at Veteran's Administration Medical Center in Dayton, OH who have history of Mild Traumatic Brain Injury within 24 months prior to enrollment.
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.
Contacts and Locations| United States, Ohio | |
| Kettering Health Network | |
| Kettering, Ohio, United States, 45429 | |
| Principal Investigator: | Jason Parker, PhD | Kettering Health Network |
More Information
No publications provided
| Responsible Party: | Kettering Health Network |
| ClinicalTrials.gov Identifier: | NCT01044615 History of Changes |
| Other Study ID Numbers: | mTBI |
| Study First Received: | January 6, 2010 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kettering Health Network:
|
Mild Traumatic Brain Injury Concussion Magnetic Resonance Imaging (MRI) Positron Emission Tomography(PET) Computed Tomography (CT) |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013