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CompletedNCT01020318Updated Oct 6, 2017

Evaluation of Outcome Measures for Patients Diagnosed With Traumatic Brain Injury

An observational study in Traumatic Brain Injury, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
9
Ages
18 Years and older
Sex
All
01

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.
Read the detailed description

The objective of this study is to evaluate potential test instruments in the traumatic brain injury (TBI) patient population. We will assess outcome measures that test neuropsychological, cognitive, communicative, and physical functional outcomes on up to 60 patients with TBI and 20 healthy volunteers. Our aims are to evaluate the appropriateness of specific tests for TBI as well as to test patient tolerance of an extensive battery of assessments and the time required to complete the assessments. We will also focus on improving staff competencies as they relate to new or novel assessments on the TBI patient population.

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Conditions studied

  • Traumatic Brain Injury

Keywords

  • Traumatic Brain Injury
  • TBI
  • Brain Injuries
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 9 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. For TBI patients: a diagnosis of TBI within the last 5 years

    1. For Healthy volunteers: no episode of head trauma resulting in an alteration in level of consciousness or loss of memory for the event.

Exclusion criteria

EXCLUSION CRITERIA:

For both study populations:

  1. Age less than 18 years
  2. Inability to speak or understand English well enough to complete study instruments
  3. 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.
  4. Unable to provide informed consent.
05

Study design

Time perspective
Prospective
Enrollment
9 participants (actual)
06

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01020318
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
United States Department of Defense, Center for Neuroscience and Regenerative Medicine (CNRM)
First posted
Nov 25, 2009
Start date
Oct 16, 2009
Completion
May 16, 2014
Last update
Oct 6, 2017

Study contacts

Leighton Chan, M.D.
principal investigator · National Institutes of Health Clinical Center (CC)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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