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

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01021137
First received: November 24, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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
Dizziness
Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vestibular Consequences of Blast-related Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • peripheral vestibular function [ Time Frame: once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • central vestibular/CNS function [ Time Frame: once ] [ Designated as safety issue: No ]
  • postural stability [ Time Frame: once ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: once ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
OEF/OIF veterans complaining of dizziness and/or imbalance with a history of blast exposure and mTBI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021137

Contacts
Contact: Faith Akin, PhD (423) 926-1171 ext 7376 faith.akin@va.gov
Contact: Owen D Murnane, PhD (423) 926-1171 ext 7632 owen.murnane@va.gov

Locations
United States, Tennessee
James H. Quillen VA Medical Center Recruiting
Mountain Home, Tennessee, United States, 37684
Contact: Jennifer R Sears    423-926-1171 ext 7941    jennifer.sears@va.gov   
Contact: Stephanie Byrd    (423) 926-1171 ext 7872    stephanie.byrd@va.gov   
Principal Investigator: Faith Akin, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Faith Akin, PhD James H. Quillen VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01021137     History of Changes
Other Study ID Numbers: C6841-R
Study First Received: November 24, 2009
Last Updated: January 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
vestibular function tests
postural balance
neuroimaging

Additional relevant MeSH terms:
Dizziness
Vertigo
Brain Injuries
Wounds and Injuries
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 21, 2014