Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury

NCT01044615 | Completed

• 1 other identifier: mTBI
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury; Concussion; Magnetic Resonance Imaging (MRI); Positron Emission Tomography(PET); Computed Tomography (CT)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kettering Health Network: lead
• University of Cincinnati: collaborator

Study Sites (1)

Kettering Health Network

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jason Parker, PhD

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: December 1, 2010
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

US (1)