Developing Therapies for Traumatic Brain Injury

NCT01420939 | Terminated

• 2 other identifiers: 11021311-NR-0213
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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 changes over time in people with TBI and how well a person recovers from it. To make existing TBI treatments more effective and develop new ones, researchers want to look more closely at how TBI affects people both physically and psychologically. Objectives: \- To collect medical information from people with recent traumatic brain injury and compare this information to that of healthy volunteers and of persons who have had injuries to other parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after surgery). Eligibility: 3 groups of people between the ages of 18 and 70 years will be asked to take part.

• Persons who have had a traumatic brain injury (or concussion ) within the past 30 days, OR
• Persons who are healthy and have never had a traumatic brain injury, OR
• Persons who have had an injury within the past 30 days to a part of their body other than the head (such as a broken bone, orthopedic injury, surgery) Design:
• This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit within 30 days of their injury.
• Screening: Participants will be screened with a medical history, physical examination, blood tests and electrocradiogram (ECG a routine heart test).
• The research will involve:
• Giving blood samples (no more than 75 ml each visit).
• Having tests of memory, attention, concentration, and thinking (neuropsychological testing).
• Having imaging studies of the head including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.
• Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and persons with non-TBI injuries will have the same tests at Visit 1 as listed above. But, at Visit 2, they will not have brain MRIs or PETs.
• No treatments will be provided as part of this research protocol.

Conditions

Traumatic Brain Injury

Keywords

TBI; Brain; Traumatic Brain Injury; Biomarkers; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Difference in levels BMs of neovascularization, neuroinflammation, and BM of severity of TBI and epigenetic changes in TBI group in comparison to volunteer group and trauma patients.

Secondary Outcomes (1)

• Correlation of levels of the BMs of neovascularization, neuroinflammation and severity of TBI to TBI severity assessed by functional outcomes and imaging (MRI, PET) evaluations in TBI patients.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kraus MF, Smith GS, Butters M, Donnell AJ, Dixon E, Yilong C, Marion D. Effects of the dopaminergic agent and NMDA receptor antagonist amantadine on cognitive function, cerebral glucose metabolism and D2 receptor availability in chronic traumatic brain injury: a study using positron emission tomography (PET). Brain Inj. 2005 Jul;19(7):471-9. doi: 10.1080/02699050400025059.

  PMID: 16134735 BACKGROUND

• Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

  PMID: 16983222 BACKGROUND

• Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8. doi: 10.1097/00001199-200611000-00009.

  PMID: 17122685 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jessica Gill, Ph.D.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 22, 2011
• Study Start: July 21, 2011
• Study Completion: May 21, 2013
• Last Updated: December 12, 2019

Record last verified: 2013-05-21

Locations

US (1)