Evaluation of Outcome Measures for Patients Diagnosed With Traumatic Brain Injury
Completed
Conditions studied: Traumatic Brain Injury
In brief
Background: * Traumatic brain injury (TBI) is a significant injury in the Armed Forces, but it is also common in the general population. This condition poses significant challenges for both diagnosis and therapy. However, the biological and neurological reasons for TBI remain poorly understood and are in need of more in-depth study. * The National Institutes of Health is collaborating with several military medical centers and research units in a multi-year study of TBI in civilian and military patients. In anticipation of these research projects, the Clinical Center s Rehabilitation Medicine Department needs to become familiar with the instruments they will likely need to evaluate this group of subjects. Objectives: * To evaluate potential test instruments in patients with TBI. * To evaluate patient tolerance of an extensive battery of assessments and the time required to complete the assessments. * To improve staff competencies on new or novel assessments of the TBI patient population Eligibility: * Individuals 18 years of age and older who have been diagnosed with a traumatic brain injury in the past 5 years. * Healthy volunteers 18 years of age and older who have had no instances of significant head trauma. Design: * This study requires approximately 3 days of outpatient or inpatient evaluation. * Subjects will undergo cognitive and neuropsychological tests, physical assessments, speech and language evaluation, and balance testing. Tests will be given orally, in writing, and on computers. The testing will be done in blocks of 2 to 3 hours, with rest periods as needed. * Subjects may undergo any or all of the following assessments and screening tools, as determined by the researchers: * Cognitive, quality of life, and functional assessments * Speech, language, and swallowing assessments * Physical functional performance and environment assessments (including balance testing) * Subjects will remain under the care of their own health care providers while participating in this study.
Key facts
- Study ID
- NCT01020318
- Run by
- National Institutes of Health Clinical Center (CC)
- People needed
- 9
- Starts
- 2009-10-16
- Expected to finish
- 2014-05-16
- Last updated by the study team
- 2017-10-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- For both study populations:
- Age less than 18 years
- Inability to speak or understand English well enough to complete study instruments
- Medically unstable on evaluation by an RMD physician, including those with clinically significant medical conditions that would make the research evaluations unsafe, logistically difficult or impossible to complete.
- Unable to provide informed consent.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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