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

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ClinicalTrials.gov Identifier: NCT01021137
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

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Study Type : Observational
Actual Enrollment : 140 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
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 participants with no complaints of dizziness and/or imbalance or history of TBI or blast exposure
Excluded
Participants who did not meet inclusion criteria, did not return to complete evaluation, and/or were excluded from data analysis.



Primary Outcome Measures :
  1. Peripheral Vestibular Function (Vestibulo-ocular Reflex/Semicircular Canal): Caloric Weakness [ Time Frame: up to 30 minutes ]
    The caloric weakness was determined using monothermal warm inter-ear difference (MWIED) which was calculated as: (|RW| - |LW| )/( |RW| + |LW|) x 100, where RW = the maximum slow phase velocity (SPV) of nystagmus induced by warm water irrigation in the right ear and LW = the maximum SPV of nystagmus induced by warm water irrigation in the left ear. For participants with MWIED > 10, then cool caloric irrigation was also performed and caloric weakness was determined using a bithermal inter-ear difference (BIED) calculated as: (|RW| + |RC|) - (|LW| + |LC|) / (|RW| + |RC| + |LW| + |LC|) x 100, where RC = maximum SPV of nystagmus induced by cool water irrigation in the right ear and LC = maximum SPV of nystagmus induced by cool water irrigation in the left ear.

  2. Rotary Chair Slow Harmonic Acceleration (SHA) Gain [ Time Frame: up to 30 minutes ]
    Rotary chair slow harmonic acceleration (SHA) vestibulo-ocular reflex (VOR) gain at 0.01 Hz was used as a measure of peripheral vestibular function (VOR/horizontal semicircular canal). VOR gain is defined as the ratio of the slow component velocity eye movement (output) to the velocity of the head movement (input).

  3. Peripheral Vestibular Function (Saccular-collic Pathway): Cervical Vestibular Evoked Potential (cVEMP) [ Time Frame: Up to 30 minutes ]
    Air-conducted cervical vestibular evoked potential (cVEMP) inter-ear amplitude asymmetry ratio was used as a measure of otolith organ function (saccular-collic pathway). Inter-ear amplitude asymmetry ratio was calculated as: [(|L_P1-N1| - |R_P1-N1|)/ (|L_P1-N1| + |R_P1-N1|)] x100, where L_P1-N1 = peak-to-peak cVEMP amplitude of the left side and R_P1-N1 = peak-to-peak cVEMP amplitude of the right side. The amplitudes were calculated from cVEMP responses at a stimulus intensity of 120 dB peakSPL. The criterion for abnormal cVEMP was defined as an absent cVEMP or a corrected cVEMP amplitude asymmetry ratio greater than or equal to 40%, either of which would indicate a unilateral vestibular loss. A bilateral vestibular loss was indicated by absent cVEMPs bilaterally.

  4. Rotary Chair Slow Harmonic Acceleration (SHA) Phase [ Time Frame: Up to 30 minutes (SHA phase is obtained simultaneously with SHA gain) ]
    Rotary chair slow harmonic acceleration (SHA) vestibulo-ocular reflex (VOR) phase at 0.01 Hz was used as a measure of peripheral vestibular function (VOR/horizontal semicircular canal). The phase is the timing difference between the velocity of head movement and the slow-phase eye velocity. This parameter is normalized for a full cycle of a sinusoid (360 degrees) and presented in an angular unit of degrees rather than a unit of time. For perfectly compensatory eye movements the phase is 0 degrees, meaning there is no difference between the actual eye velocity and the ideal VOR (by convention, degrees is added to the phase so that the comparison is based on the ideal VOR responses instead of the actual head motion).

  5. Peripheral Vestibular Function (Utricular-ocular Pathway): Ocular Vestibular Evoked Potential (oVEMP) [ Time Frame: Up to 20 minutes ]
    Bone-conducted ocular vestibular evoked potential (oVEMP) inter-ear amplitude asymmetry ratio was used as a measure of otolith organ function (utricular-ocular pathway). Inter-ear amplitude asymmetry ratio was calculated as: [(|L_N1-P1| - |R_N1-P1|)/ (|L_N1-P1| + |R_N1-P1|)] x100, where L_N1-P1 = peak-to-peak oVEMP amplitude of the left eye/right ear and R_N1-P1 = peak-to-peak oVEMP amplitude of the right eye/left ear. The oVEMP is a contralateral response; therefore, recordings from the left eye reflect the response of the right ear and vice versa. The amplitudes were calculated from oVEMP responses at a stimulus intensity of 155 dB peakFL. The criterion for abnormal oVEMP was defined as an absent oVEMP or a corrected oVEMP amplitude asymmetry ratio greater than or equal to 40%, either of which would indicate a unilateral vestibular loss. A bilateral vestibular loss was indicated by absent oVEMPs bilaterally.


Secondary Outcome Measures :
  1. Central Vestibular/Central Nervous System (CNS) Function: Visual Fixation Suppression [ Time Frame: 1 minute ]
    Visual fixation suppression was used as a measure of central vestibular/CNS function. Visual fixation suppression is a measure of vestibulo-ocular reflex (VOR) gain obtained during visual fixation at 0.16 Hz slow harmonic acceleration on the rotary chair. VOR gain was defined as the ratio of the slow component velocity eye movement (output) to the velocity of the head movement (input). Visual fixation suppression was considered normal if VOR gain is suppressed > 50% with visual fixation compared to no fixation.

  2. Postural Stability: Sensory Organization Test (SOT) [ Time Frame: Up to 20 minutes ]
    This measure is the composite equilibrium score from six conditions of the sensory organization test obtained with the Neurocom Equitest. Results of the SOT were calculated based on maximum peak-to-peak anterior-posterior sway expressed as an equilibrium score ranging from 0 to 100, with 0 indicating loss of balance (i.e., required support of harness, took a step, touched walls for support or opened eyes in eyes closed conditions) and 100 indicating perfect stability. The outcome measure was the equilibrium composite score and was calculated by the software as the weighted average of the equilibrium scores for the six conditions. For ages 18-59 years, the normative value (mean - 1.67 SD) for the composite score is at least 70 (NeuroCom, 2011).

  3. Dizziness Handicap Inventory [ Time Frame: Up to 10 minutes ]
    The Dizziness Handicap Inventory (DHI) was used as a quality of life measure.The DHI measures the subject's self-perceived dizziness. The scale has 25 questions with 3 possible answers each: "Yes" = 4 points, "Sometimes" = 2 points, and "No" = 0 points. The minimum number of points that a subject can score is 0 and the maximum number of points is 100. The subject's self-perceived dizziness is reported as a percentage with a range of 0-100%, and is calculated by: subject's total number of points/maximum number of points (100) x 100%. The higher the score on the DHI, the worse a patient's self-perceived dizziness.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Faith Akin, PhD Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01021137    
Other Study ID Numbers: C6841-R
First Posted: November 26, 2009    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: June 2019
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:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Dizziness
Wounds and Injuries
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