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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):

Study Description
Brief Summary:
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.

Condition or disease
Dizziness Brain Injury

Detailed Description:

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.


Study Design

Study Type : Observational
Estimated Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vestibular Consequences of Blast-related Mild Traumatic Brain Injury
Actual Study Start Date : May 1, 2011
Primary Completion Date : December 30, 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. peripheral vestibular function [ Time Frame: once ]

Secondary Outcome Measures :
  1. central vestibular/CNS function [ Time Frame: once ]
  2. postural stability [ Time Frame: once ]
  3. quality of life [ Time Frame: once ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
OEF/OIF Veterans
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021137


Locations
United States, Tennessee
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, United States, 37684
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Faith Akin, PhD Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01021137     History of Changes
Other Study ID Numbers: C6841-R
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
vestibular function tests
postural balance
neuroimaging

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Dizziness
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms