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Vestibular Consequences of Blast-related Mild Traumatic Brain Injury (TBI)

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ClinicalTrials.gov Identifier: NCT01021137
Recruitment Status : Active, not recruiting
First Posted : November 26, 2009
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

November 24, 2009
November 26, 2009
April 27, 2017
May 1, 2011
December 30, 2016   (Final data collection date for primary outcome measure)
peripheral vestibular function [ Time Frame: once ]
Same as current
Complete list of historical versions of study NCT01021137 on ClinicalTrials.gov Archive Site
  • central vestibular/CNS function [ Time Frame: once ]
  • postural stability [ Time Frame: once ]
  • quality of life [ Time Frame: once ]
Same as current
Not Provided
Not Provided
 
Vestibular Consequences of Blast-related Mild Traumatic Brain Injury (TBI)
Vestibular Consequences of Blast-related Mild Traumatic Brain Injury
The purpose of this project is to determine the effects of mild traumatic brain injury and blast exposure on the inner ear balance and central nervous systems.

The goal of this project is to determine the effects of mild traumatic brain injury (mTBI) and blast exposure on the vestibular system and CNS. Dizziness and balance disorders are common symptoms associated with mTBI or head injury. Numerous studies have provided significant evidence that mTBI or head injury can cause damage to the vestibular system; however, most have limited the vestibular evaluation to assessment of horizontal semicircular canal function. Recently, methods have been developed to assess otolith function, and there is some evidence that head injury may affect the otolith organs to a greater degree than the semicircular canals.

mTBI has been called the signature condition of Veterans returning from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), and the cause is often related to blast exposure from improvised explosive devices, mortars or rocket-propelled grenades. Some investigators have presumed that dizziness and balance disorders following blast exposure are related to CNS damage caused by the TBI rather than the pressure wave from the blast injury. Thus, most research has focused on the vestibular consequences of TBI (or head injury), and there is limited data on the effects of blast exposure on vestibular function or balance. Recently, magnetic resonance imaging techniques have been developed that may allow for testing the assumption that the symptoms of dizziness or imbalance related to head injury or blast exposure are often due to central vestibular or CNS involvement.

Specific aims of this project are to determine the effect of mTBI and blast exposure on (1) peripheral vestibular system function (specifically, horizontal semicircular canal function, and otolith organ function), (2) central vestibular/CNS function, (3) postural stability, and (4) dizziness-related quality of life. Four subject groups will include Veterans complaining of dizziness/imbalance with (1) a history of blast exposure, (2) with mTBI, (3) with blast exposure and mTBI, and (4) a control group. Each subject will undergo tests of horizontal semicircular canal function (caloric and rotary chair), tests of otolith function (vestibular evoked myogenic potentials, subjective visual vertical), central vestibular function/CNS function (ocular motor tests, diffusion tensor and susceptibility weighting imaging), gait and balance testing, and the Dizziness Handicap Inventory.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
OEF/OIF Veterans
  • Dizziness
  • Brain Injury
Not Provided
  • TBI & Blast
    OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure and a diagnosis of mild TBI
  • Blast Only
    OEF/OIF Veterans complaining of dizziness and/or imbalance with history of blast exposure without TBI
  • TBI Only
    OEF/OIF Veterans complaining of dizziness and/or imbalance with a history of mild TBI and no blast exposure
  • Healthy Controls
    Age and gender matched control subjects with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
192
Same as current
December 2017
December 30, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Complaint of dizziness and/or imbalance
  • History of blast exposure
  • Diagnosis of mild traumatic brain injury

Exclusion Criteria:

  • Prior history of vestibular or neurological disorder
  • Presence of internal metal
  • Pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01021137
C6841-R
No
Not Provided
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Faith Akin, PhD Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
VA Office of Research and Development
April 2017