Traumatic Brain Injury Clinical Trial in Bethesda MD
NCT01132937
| Observational
This study has recruited 886 Participants
Background:
- Traumatic brain injury may have a range of effects, from severe and permanent disability to
more subtle functional and cognitive deficits that often go undetected during initial
treatment. To improve treatments and therapies and to provide a uniform quality of care,
researchers are interested in developing more standardized criteria for diagnosing and
classifying different types of traumatic brain injury. By identifying imaging and other
indicators immediately after the injury and during the initial treatment phrase, researchers
hope to better understand the nature and effects of acute traumatic brain injury.
Objectives:
- To study the MRI results of individuals who have recently had head injury and suspected
traumatic brain injury.
- To study the natural evolution of traumatic brain injury for up to 3 months after head
injury.
Eligibility:
- Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed
or suspected traumatic brain injury within the past 48 hours.
Design:
- Participants will have one 3-hour study visits: an initial visit (within 48 hours of
head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and
1-year follow-up.
- Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a
series of tests to evaluate brain function.
- At the optional follow-up visit, participants may have blood samples, an MRI scan, and a
general traumatic brain injury assessment.
- This study does not provide treatment and does not replace any current therapies.
However, participants who are eligible for other National Institutes of Health studies
may be referred to these studies by researchers.
Details for the study
Population
Enrollment in this protocol will occur at a participating site MedStar Washington Hospital
Center (WHC) or Johns Hopkins Suburban Hospital (Suburban). Applicable study procedures
will depend on the visit site, diagnostic certainty, and logistic considerations such as
ability to be moved to MR suite for imagining in local hospital. All subjects will undergo
a study visit at a participating enrollment site with in 48hrs of suspected head injury.
Brief Title
Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
Official Title
Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
Brief Summary
Background:
<br />
<br /> - Traumatic brain injury may have a range of effects, from severe and permanent disability to
<br /> more subtle functional and cognitive deficits that often go undetected during initial
<br /> treatment. To improve treatments and therapies and to provide a uniform quality of care,
<br /> researchers are interested in developing more standardized criteria for diagnosing and
<br /> classifying different types of traumatic brain injury. By identifying imaging and other
<br /> indicators immediately after the injury and during the initial treatment phrase, researchers
<br /> hope to better understand the nature and effects of acute traumatic brain injury.
<br />
<br /> Objectives:
<br />
<br /> - To study the MRI results of individuals who have recently had head injury and suspected
<br /> traumatic brain injury.
<br />
<br /> - To study the natural evolution of traumatic brain injury for up to 3 months after head
<br /> injury.
<br />
<br /> Eligibility:
<br />
<br /> - Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed
<br /> or suspected traumatic brain injury within the past 48 hours.
<br />
<br /> Design:
<br />
<br /> - Participants will have one 3-hour study visits: an initial visit (within 48 hours of
<br /> head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and
<br /> 1-year follow-up.
<br />
<br /> - Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a
<br /> series of tests to evaluate brain function.
<br />
<br /> - At the optional follow-up visit, participants may have blood samples, an MRI scan, and a
<br /> general traumatic brain injury assessment.
<br />
<br /> - This study does not provide treatment and does not replace any current therapies.
<br /> However, participants who are eligible for other National Institutes of Health studies
<br /> may be referred to these studies by researchers.
Detailed Description
Objective
To generate natural history data for cohort-based comparisons to serve as the basis for
hypothesis-driven studies and to contribute to the clinical and physiological understanding
of traumatic brain injury (TBI) through the description of manifestations of the injury and
the relationship among radiological, hematological, clinical variables and standard
functional outcome measures.
Study Population
One thousand male and female adult subjects with history of recent head injury with or
suspected non-penetrating acute TBI, will be enrolled. Subjects having varying degrees of TBI
severity will be recruited from the collaborative programs between NIH and non-NIH hospitals.
We anticipate approximately 80% of subjects will be classified as mild TBI, concussion, or no
injury.
Design
This is a prospective study of subjects with known and suspected non-penetrating acute
traumatic brain injury. Subjects presenting to the emergency department or trauma service at
participating hospitals with a history of recent suspected head injury will be studied during
the course of their hospital stay and after discharge using radiological, hematological,
clinical and functional outcome measures. Subjects will be stratified according to findings
and time of initial imaging into cohorts for comparison.
The design is intentionally broad in scope to allow acquisition of data for the development
of future hypothesis-driven research. Research performed under this protocol will not
interfere with standard of care and subjects will not be treated with experimental therapies
as part of the research study. Data collected under this research study may be shared without
personal identifiers with other researchers if subjects approve this option on the informed
consent. Data and samples collected under this protocol and other protocols that allow data
sharing will be combined for secondary analysis under this protocol.
Outcome Measures
A variety of outcome measures will be used including diagnosis, evidence of injury on
magnetic resonance imaging (MRI) and positron emission tomography (PET), functional
impairment, and quality of life (QOL) assessments. Research questions will focus on a
positive diagnosis of brain injury and monitoring the natural history. Statistical analysis
plans will be developed as specific research questions and hypotheses are generated.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Evidence of injury on MRI of the brain vasculature.
Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, and TBI outcome scales
Secondary
Success/failure rate for acute MRI in relationship to attempted and those able to undergo CT
Imaging findings on CT in comparison to that of MRI and PET - TBI Outcome Scales
Study Criteria
INCLUSION CRITERIA:
Suspected TBI Subjects
Suspected TBI subjects must meet the following inclusion criteria:
1. History of acute head injury with or suspected non-penetrating acute TBI
2. Age 18 years or older
3. Deemed medically safe for study participation by the subject s attending physician
4. Able to provide consent or have a legally-authorized representative provide consent.
Healthy Volunteers
Healthy volunteers must meet the following inclusion criteria:
1. Healthy without past or present history of TBI or other brain disease, as evaluated by
medical history and physical exam
2. Age 18 or older.
3. Able to provide informed consent
EXCLUSION CRITERIA:
Suspected TBI Subjects
Suspected TBI subjects are not eligible for participation in this research study if any of
the following conditions exist:
1. Considered to be psychiatrically unstable by the patient s attending physician
2. Contraindication to MRI scanning including: pacemakers or other implanted electrical
devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips
on the wall of a large artery), metallic prostheses (including metal pins and rods,
heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or
shrapnel fragments.
3. Conditions precluding entry into the scanner such as morbid obesity or claustrophobia
or conditions requiring sedation.
4. In female subjects, pregnancy.
Healthy Volunteers
Healthy volunteers are not eligible for participation in this research study if any of the
following conditions exist:
1. Presence of cognitive impairment based on medical history and/or Mini Mental State
Examination (MMSE) score of < 27
2. Current or past DSM-IV diagnosis of a psychiatric disorder including substance use
disorder as determined by self-report, medical history, and/or clinical exam
3. Major medical problems that can impact brain function (e.g., problems of the CNS
including seizures and psychosis; cardiovascular disease including hypertension and
arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report,
medical history and/or clinical exam;
4. Contraindication to MRI scanning including certain metal implants or devices such as:
cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear,
otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be
removed for the study, 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 subject 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
subject s eyes).
5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia,
etc.).
6. In female subjects, pregnancy or breastfeeding.
7. Exposure to research related radiation in the past year that, when combined with this
study, would place subjects above the allowable limits.
Currently Phase-1 of enrollment for healthy volunteers in the A Beta PET pilot is complete.
At this time enrollment of healthy volunteers is on hold until analysis complete.
Enrollment of A Beta PET pilot TBI subjects and healthy matches may resume under Phase-2 if
analysis of initial data suggests update
