Status:
TERMINATED
Developing Therapies for Traumatic Brain Injury
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Brief Summary
Background: \- A person who has a traumatic brain injury (TBI) -- also called concussion -- can have serious and long-lasting effects. Doctors who treat TBI need more information about how the brain ...
Detailed Description
Traumatic brain injury (TBI) is the leading cause of death and disability in people under age 45 in industrialized countries, but there is no specific treatment available for TBI. Circulating endothel...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 21 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 21 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01420939
Start Date
July 21 2011
End Date
May 21 2013
Last Update
December 12 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892