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Evaluation of Outcome Measures for Patients Diagnosed With Traumatic Brain Injury

NCT01020318 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2017-10-06

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Leighton Chan, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-16
Completion
2014-05-16

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020318 on ClinicalTrials.gov