Developing Therapies for Traumatic Brain Injury

• INCLUSION CRITERIA FOR TBI PATIENTS:

To be included, TBI patients must meet all of the following criteria:

• Between 18 and 70 years of age
• Had head injury within the previous 30 days.
• Had a moderate TBI classified as GCS 9-12 or a mild TBI classified as GCS 13-15 at the first ER or other medical examination. If LOC existed, it may not have lasted more than 24 hours. If PTA existed it may not be more than 7 days.
• Admitted to an inpatient unit, ED, and/or evaluated in a doctors' office because of head trauma.
• Injury occurred less than 30 (plus 5) days before enrollment
• Willingness to provide permission to allow release of medical records related to these injuries.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Healthy volunteers will be eligible for enrollment if they meet the following inclusion requirements:

• Between 18 and 70 years of age
• Determined to be healthy at the time of screening
• No known previous TBI, even mild (characterized as GCS >13, PTA < 1 day LOC < 30 min)

INCLUSION CRITERIA FOR NON-TBI TRAUMA CONTROLS:

Non-TBI trauma controls will be eligible for enrollment if they meet the following criteria:

• Between 18 and 70 years of age
• Evaluated in an emergency department or in a physician s office or admitted to an inpatient unit because of isolated traumatic injury resulting in a fracture (e.g, limbs, ribs) or other orthopedic injury (ligament, tendon or joint injury) or non-life threatening condition requiring surgery (appendectomy, etc.).
• No known previous TBI, even mild (characterized as GCS > 13, PTA < 1 day LOC < 30 min)
• Evaluated within 30 (plus 5) days after the trauma
• Willingness to provide permission to allow release of medical records related to these injuries.

EXCLUSION CRITERIA FOR ALL STUDY PARTICIPANTS:

Study participants will be excluded from the study if he/she has one or more of the following:

• Are not able to read and understand English to complete outcome assessments and neurological scales
• Progressive or unstable disease of any body system including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders
• Alcohol dependence/substance abuse history within the past 5 years
• Known acute and chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematosus, hepatitis, cirrhosis, sepsis, severe periodontosis or HIV infection or AIDS.
• Clinically significant abnormal ECG, or acute myocardial infarction within last 3 months
• Ischemic or hemorrhagic stroke within last 3 months
• History of diabetes
• Currently undergoing evaluation or treatment for chronic illness or presenting with symptoms suggestive of undiagnosed disorders
• Pregnant or lactating women

EXCLUSION CRITERIA FOR BRAIN MRI:

Of the participants and volunteers enrolled under the listed inclusion/exclusion, the following will not be eligible for MRI scanning but will undergo all other study procedures:

• Contraindication to MRI scanning, including certain metal implants or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a participant s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the participant s eyes)
• Previous trauma or accidents in the past with non-certainty that metal objects are still present in the body
• A condition precluding entry into the scanner (e.g. morbid obesity or claustrophobia)
• Pregnant women or women who are breast-feeding.
• Inability to lie flat on back for up to 90 minutes

EXCLUSION CRITERIA FOR BRAIN PET:

• A condition precluding entry into the scanner (e.g. morbid obesity or claustrophobia)
• Pregnancy or breast-feeding
• Blood glucose over 200 mg/dL when measured before the PET scanning
• Previous radiation exposure where the additional exposure from the PET scan would exceed NIH annual limits