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

This study has been completed.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Kettering Health Network
ClinicalTrials.gov Identifier:
NCT01044615
First received: January 6, 2010
Last updated: January 10, 2013
Last verified: January 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Kettering Health Network:

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
Normal Control
Normal, healthy adults with no history of brain injury.

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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044615

Locations
United States, Ohio
Kettering Health Network
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Kettering Health Network
University of Cincinnati
Investigators
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
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014