Vestibular Consequences of Blast-related Mild Traumatic Brain Injury (TBI)
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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 |
- peripheral vestibular function [ Time Frame: once ] [ Designated as safety issue: No ]
- 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: | January 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Group 1
OEF/OIF veterans complaining of dizziness and/or imbalance with a history of blast exposure and mTBI
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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 |
OEF/OIF veterans
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| 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 |
| United States, Tennessee | |
| James H. Quillen VA Medical Center | Recruiting |
| Mountain Home, Tennessee, United States, 37684 | |
| Contact: Amber Pearson 423-926-1171 ext 7941 amber.pearson2@va.gov | |
| Contact: Stephanie Byrd (423) 926-1171 ext 7872 stephanie.byrd@va.gov | |
| Principal Investigator: Faith Akin, PhD | |
| 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: | February 26, 2013 |
| 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 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 Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013