Evaluation of Outcome Measures for Patients Diagnosed With Traumatic Brain Injury
|ClinicalTrials.gov Identifier: NCT01020318|
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : October 6, 2017
- 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.
- 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
- 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.
- 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.
|Condition or disease|
|Traumatic Brain Injury|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Evaluation of Outcome Measures for Patients Diagnosed With Traumatic Brain Injury|
|Study Start Date :||October 16, 2009|
|Study Completion Date :||May 16, 2014|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020318
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Leighton Chan, M.D.||National Institutes of Health Clinical Center (CC)|