<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03251586</url>
  </required_header>
  <id_info>
    <org_study_id>140805</org_study_id>
    <nct_id>NCT03251586</nct_id>
  </id_info>
  <brief_title>Test-Retest Reliability of oVEMP's Across Different Electrode Montages</brief_title>
  <official_title>Test-Retest Reliability of oVEMP's Across Different Electrode Montages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Test-Retest Reliability of ocular vestibular evoked myogenic potentials (oVEMPs) across&#xD;
      different electrode montages.&quot;&#xD;
&#xD;
      The purpose of this project is to compare the response characteristics of the ocular&#xD;
      vestibular evoked myogenic potential in patients grouped by decade (i.e. 20's-90's) using two&#xD;
      different recording montages and two different stimulus types (i.e. air and bone conducted&#xD;
      sound). The long-term goal is to increase the sensitivity and specificity of the oVEMP when&#xD;
      used clinically to identify vestibular disorders affecting the utricle and superior portion&#xD;
      of the vestibular nerve.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim: Compare the difference in the contralateral peak-to-peak N1-P1 amplitude and N1&#xD;
      latency between the belly tendon electrode montage with the conventional infraorbital&#xD;
      electrode montage in otologically normal patients grouped by decade with the goal of&#xD;
      developing normative values to use clinically.&#xD;
&#xD;
      The oVEMP is a short latency (~10 ms), negative polarity evoked myogenic potential that is&#xD;
      recorded from the extraocular muscles. The oVEMP test is well-tolerated by patients and is&#xD;
      simple to administer. Whereas the recording of the cVEMP to air-conducted stimuli represents&#xD;
      a means for evaluating the function of the saccule and inferior vestibular nerve, the oVEMP&#xD;
      in response to mechanical, and probably air conducted stimuli, is now felt to represent a&#xD;
      method for assessing the functional integrity of the utricle and superior vestibular nerve.&#xD;
&#xD;
      The oVEMP response is recorded from beneath both the ipsilateral and contralateral eyes, but&#xD;
      the largest response is typically seen in the contralateral recording. The contralateral&#xD;
      utricular-ocular pathway terminates on the inferior oblique muscle, the electrical field of&#xD;
      which can be recorded by an electrode placed at the midline of the lower lid and having the&#xD;
      subject gaze upward (i.e. which results in the inferior oblique muscle becoming more&#xD;
      superficial to the location of the surface electrode.&#xD;
&#xD;
      The the absolute oVEMP N1 peak-to-peak amplitude has become the most important measurement&#xD;
      for diagnostic purposes. Typical oVEMP latencies are ~11 ms for the negative peak (N1) and&#xD;
      ~15 ms for the following positive peak (P1) .&#xD;
&#xD;
      Variables that may confound recording oVEMPs include body position and electrode montages.&#xD;
      Regarding electrode placement, there are three different electrode montages that have been&#xD;
      studied and implemented clinically. The vast majority of clinics favor the electrode montage&#xD;
      reported in the early papers describing the oVEMP. The authors reported that the&#xD;
      non-inverting electrode was placed infraorbitally at the margin of the lower eyelid. The&#xD;
      inverting electrode was placed 2 cm inferior to the location of the non-inverting electrode.&#xD;
      Two additional electrode montages that have been reported include: 1) the noninverting&#xD;
      electrodes placed at the margin of the lower eyelid slightly lateral to midline and the&#xD;
      inverting electrode placed rostral to the inner canthus of the eye, and, 2) the noninverting&#xD;
      electrodes placed at the middle of the lmargin of the lower eyelid and a single common&#xD;
      inverting electrode placed on the chin. A report by Sandhu et al. (2013) indicated that the&#xD;
      maximal oVEMP amplitude was recorded with the former electrode montage. In this montage, the&#xD;
      inverting electrode is placed over a tendon, which is believed to be (relatively)&#xD;
      electrically neutral.&#xD;
&#xD;
      Skin surface electrodes are sensitive to the desired muscle activity (i.e. signal) recorded&#xD;
      locally as well as non-stimulus-related electrical activity (i.e. noise) that can be both&#xD;
      endogenous and exogenous. Where the signal is common to both the inverting and non-inverting&#xD;
      electrodes this activity routed into a differential electrode can result in cancellation of&#xD;
      some or all of the desired signal.&#xD;
&#xD;
      Recently published data from our laboratory has shown that the Sandhu montage (i.e. the&#xD;
      &quot;belly-tendon electrode montage) in the sitting position is the optimal method for testing&#xD;
      patients who are otologically and neurologically normal. This montage is associated with a&#xD;
      larger N1 amplitude and a larger peak-to-peak amplitude for oVEMP measurements for young,&#xD;
      normal patients. Due to the knowledge that the amplitude of the oVEMP response decreases with&#xD;
      age, however, normative values based on decade would be necessary to have the oVEMP response&#xD;
      be as clinically useful as possible.&#xD;
&#xD;
      Significance and Potential of the Research:&#xD;
&#xD;
      Establishing normative values based on decade will allow for higher sensitivity and&#xD;
      specificity to vestibular impairments affecting the utricle and superior portion of the&#xD;
      vestibular nerve, as well as increase the sensitivity and specificity to disorders such as&#xD;
      Superior Semicircular Canal Dehiscence Syndrome.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Subjects: Participants will include groups of patients between 20-90 years of age. The groups&#xD;
      will be composed of 10-15 subjects per group to allow for normative data to be calculated.&#xD;
      Participants will be recruited by phone using databases housed in the Odess Otolaryngology&#xD;
      Department at Vanderbilt Bill Wilkerson Center, via flyers posted at Vanderbilt University&#xD;
      Medical Center, and through Research Match email blasts. The study protocol will undergo&#xD;
      review by the Vanderbilt Institutional Review Board (submitted-see Appendix).&#xD;
&#xD;
      oVEMP Recording: For the oVEMP recording (utricular assessment), subjects will be seated in a&#xD;
      comfortable reclining will be compared during this study. First, an electrode montage and&#xD;
      recording parameters similar to those reported by Chihara et al. (2007) will be used to&#xD;
      record the oVEMP. Disposable silver/silverchloride electrodes will be placed infraorbitally&#xD;
      beneath each eye (i.e., infraorbital 1 cm) representing the non-inverting amplifier inputs&#xD;
      and 3cm infraorbitally will serve as the location for the inverting electrode. A second&#xD;
      electrode montage with recording parameters similar those reported by Sandhu et al. (2013)&#xD;
      will be used simultaneously to record oVEMP responses. Disposable silver/silverchloride&#xD;
      electrodes will be placed on the belly of the inferior oblique muscle representing the&#xD;
      non-inverting amplifier inputs and the tendon of the inferior oblique muscle will serve as&#xD;
      the location for the inverting electrode. The ground electrode will be placed at Fpz for both&#xD;
      electrode montages.&#xD;
&#xD;
      When recording the oVEMP, the subjects will be seated and instructed to keep their head at&#xD;
      midline and gaze at a target positioned ~30° upward at midline. During the recording, the&#xD;
      investigator will monitor to ensure the subject's chin is parallel to the horizon. Stimuli&#xD;
      for the oVEMP recordings will be presented monaurally through Etymotic ER-3A insert earphones&#xD;
      or a B81 bone conductor and consist of 500 Hz tone bursts presented at a rate of 5.1/sec. The&#xD;
      tone burst will have a 2 cycle rise time, 1 cycle plateau and a 2 cycle fall time. A&#xD;
      Neuroscan (Herndon, UA) multi-channel evoked potential recording system will enable us to&#xD;
      record simultaneously the oVEMP response from each of the two electrode montages. EMG&#xD;
      activity will be amplified by 100,000 times and signal averaged over 100 msec. A minimum of&#xD;
      120 individual samples will be collected for each recording. Each tracing will be replicated&#xD;
      at least one time so that the waveform reproducibility can be estimated. Order effects will&#xD;
      be eliminated by counterbalancing the order of the starting ear. oVEMPs from the two&#xD;
      electrode montages will be recorded simultaneously, so counterbalancing the electrode montage&#xD;
      will be unnecessary. A minimum of two amplitude measures will be completed for each electrode&#xD;
      montage condition in each position, for a total minimum of 8 recordings per subject. The&#xD;
      subject will be given 1-2 minutes to rest their eyes between recordings.&#xD;
&#xD;
      Stimulus level will be calibrated in dBpeak SPL using a 2-cm3 coupler to a sound-level meter&#xD;
      (Bruel &amp; Kjaer). The stimulus waveforms and amplitude spectra will be measured by routing the&#xD;
      air conduction output of the sound-level meter to a spectrum analyzer.&#xD;
&#xD;
      Statistical Methods:&#xD;
&#xD;
      Analysis: Summary statistics will be provided for all demographic and clinical variables,&#xD;
      along with 95% confidence intervals and side-by-side boxplots. Between-group differences in&#xD;
      categorical variables will be assessed via chi-squared tests while differences in continuous&#xD;
      variables will be assessed via the Wilcoxin rank-sum test (using significance level alpha =&#xD;
      0.0125 in primary analysis as per the power calculation above). Hotelling's T-squared&#xD;
      distribution will also be used as an omnibus or simultaneous test that the groups are the&#xD;
      same for all variables in the primary analysis. Amplitude differences obtained using each&#xD;
      montage will be calculated as a change expressed in percentage using the formula below:&#xD;
&#xD;
      (n1-p1 amplitude montage2 - n1-p1 amplitude montage 1)&#xD;
&#xD;
      --------------------------------------------------------------- n1-p1 amplitude montage 1&#xD;
&#xD;
      All statistical analyses will be performed with SPSS 23.&#xD;
&#xD;
      Facilities Available: The Vanderbilt Balance Disorders Laboratory is located in the Bill&#xD;
      Wilkerson Center. The Balance Disorders Laboratory is equipped with state-of-the art&#xD;
      equipment for comprehensive assessment of vestibular and auditory disorders. The facility&#xD;
      includes a sound treated room, five diagnostic audiometers, five compact disk players for&#xD;
      speech audiometry, five immittance meters, three otoacoustic emissions devices, two rotary&#xD;
      vestibular test chairs, three videonystagmography systems, a computerized&#xD;
      electronystagmography system, a computerized dynamic posturography system, a Neuroscan evoked&#xD;
      response system with capability for 64 channel simultaneous brain signal acquisition, and 4&#xD;
      2-channel clinical evoked potentials systems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to time constraints, the study will not be able to be completed as outlined&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2018</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Development of Normative Values per Decade</measure>
    <time_frame>5 months for data collection, one visit per subject.</time_frame>
    <description>The oVEMP N1-P1 amplitude and N1 latency will be measured for each subject and will be used to calculate normative values for each decade. The goal is to provide clinics with normative information to base clinical evaluations on.</description>
  </primary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vestibular Abnormality</condition>
  <condition>Vestibular Nerve Disorders</condition>
  <arm_group>
    <arm_group_label>20-29</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30-39</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40-49</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50-59</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>60-69</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>70-79</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>80-89</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90-99</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>oVEMP - infra-orbital electrode montage</intervention_name>
    <description>oVEMPs are short latency (~10 ms) stimulus-synchronized extra-ocular muscle reflexes produced in response to appropriate stimuli. The response is believed to originate from excitation of the utricular macula with the subsequent neural response relayed to the brain by the superior portion of the vestibular nerve. Changes in the electrical field of the contralateral inferior oblique muscle can be recorded by an electrode placed at the infra-ocular midline of the lower lid while having the subject gaze upward. The conventional electrode montage, the infra-orbital electrode montage, has the active electrode placed directly inferior to the eye and the reference electrode placed 2-3 cm below the active on the cheek. This electrode montage may result in reference contamination, which will cause an artificially reduced amplitude response, as a portion of the response can be measured by the reference electrode.</description>
    <arm_group_label>20-29</arm_group_label>
    <arm_group_label>30-39</arm_group_label>
    <arm_group_label>40-49</arm_group_label>
    <arm_group_label>50-59</arm_group_label>
    <arm_group_label>60-69</arm_group_label>
    <arm_group_label>70-79</arm_group_label>
    <arm_group_label>80-89</arm_group_label>
    <arm_group_label>90-99</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>oVEMP - belly-tendon electrode montage</intervention_name>
    <description>oVEMPs are short latency (~10 ms) stimulus-synchronized extra-ocular muscle reflexes produced in response to appropriate stimuli. The response is believed to originate from excitation of the utricular macula with the subsequent neural response relayed to the brain by the superior portion of the vestibular nerve. Changes in the electrical field of the contralateral inferior oblique muscle can be recorded by an electrode placed at the infra-ocular midline of the lower lid while having the subject gaze upward. The belly-tendon electrode montage consists of an active electrode placed laterally to the midline of the lower eyelid and a reference electrode placed on the inner canthus. This reference location is believed to be electrically neutral, and should therefore result in larger amplitude responses as the response would not be subject to reference contamination.</description>
    <arm_group_label>20-29</arm_group_label>
    <arm_group_label>30-39</arm_group_label>
    <arm_group_label>40-49</arm_group_label>
    <arm_group_label>50-59</arm_group_label>
    <arm_group_label>60-69</arm_group_label>
    <arm_group_label>70-79</arm_group_label>
    <arm_group_label>80-89</arm_group_label>
    <arm_group_label>90-99</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal hearing and no history of balance disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing loss, a large amount of ear wax, inner ear of balance problems, and/or no&#xD;
             recordable eye muscle responses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn F Makowiec, AuD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Chang CM, Cheng PW, Wang SJ, Young YH. Effects of repetition rate of bone-conducted vibration on ocular and cervical vestibular-evoked myogenic potentials. Clin Neurophysiol. 2010 Dec;121(12):2121-7. doi: 10.1016/j.clinph.2010.05.013. Epub 2010 Jun 11.</citation>
    <PMID>20541460</PMID>
  </results_reference>
  <results_reference>
    <citation>Chihara Y, Iwasaki S, Ushio M, Murofushi T. Vestibular-evoked extraocular potentials by air-conducted sound: another clinical test for vestibular function. Clin Neurophysiol. 2007 Dec;118(12):2745-51. doi: 10.1016/j.clinph.2007.08.005. Epub 2007 Oct 1.</citation>
    <PMID>17905655</PMID>
  </results_reference>
  <results_reference>
    <citation>Curthoys IS, Iwasaki S, Chihara Y, Ushio M, McGarvie LA, Burgess AM. The ocular vestibular-evoked myogenic potential to air-conducted sound; probable superior vestibular nerve origin. Clin Neurophysiol. 2011 Mar;122(3):611-616. doi: 10.1016/j.clinph.2010.07.018. Epub 2010 Aug 14.</citation>
    <PMID>20709596</PMID>
  </results_reference>
  <results_reference>
    <citation>Govender S, Rosengren SM, Colebatch JG. The effect of gaze direction on the ocular vestibular evoked myogenic potential produced by air-conducted sound. Clin Neurophysiol. 2009 Jul;120(7):1386-91. doi: 10.1016/j.clinph.2009.04.017. Epub 2009 May 22.</citation>
    <PMID>19464947</PMID>
  </results_reference>
  <results_reference>
    <citation>Makowiec K, McCaslin DL, Jacobson GP, Hatton K, Lee J. Effect of Electrode Montage and Head Position on Air-Conducted Ocular Vestibular Evoked Myogenic Potential. Am J Audiol. 2017 Jun 13;26(2):180-188. doi: 10.1044/2017_AJA-16-0108.</citation>
    <PMID>28520834</PMID>
  </results_reference>
  <results_reference>
    <citation>Kantner C, Gurkov R. Characteristics and clinical applications of ocular vestibular evoked myogenic potentials. Hear Res. 2012 Dec;294(1-2):55-63. doi: 10.1016/j.heares.2012.10.008. Epub 2012 Oct 30.</citation>
    <PMID>23123220</PMID>
  </results_reference>
  <results_reference>
    <citation>Murnane OD, Akin FW, Kelly KJ, Byrd S. Effects of stimulus and recording parameters on the air conduction ocular vestibular evoked myogenic potential. J Am Acad Audiol. 2011 Jul-Aug;22(7):469-80. doi: 10.3766/jaaa.22.7.7.</citation>
    <PMID>21993052</PMID>
  </results_reference>
  <results_reference>
    <citation>Nguyen KD, Welgampola MS, Carey JP. Test-retest reliability and age-related characteristics of the ocular and cervical vestibular evoked myogenic potential tests. Otol Neurotol. 2010 Jul;31(5):793-802. doi: 10.1097/MAO.0b013e3181e3d60e.</citation>
    <PMID>20517167</PMID>
  </results_reference>
  <results_reference>
    <citation>Piker EG, Jacobson GP, McCaslin DL, Hood LJ. Normal characteristics of the ocular vestibular evoked myogenic potential. J Am Acad Audiol. 2011 Apr;22(4):222-30. doi: 10.3766/jaaa.22.4.5.</citation>
    <PMID>21586257</PMID>
  </results_reference>
  <results_reference>
    <citation>Piker EG, Jacobson GP, Burkard RF, McCaslin DL, Hood LJ. Effects of age on the tuning of the cVEMP and oVEMP. Ear Hear. 2013 Nov-Dec;34(6):e65-73. doi: 10.1097/AUD.0b013e31828fc9f2.</citation>
    <PMID>23673615</PMID>
  </results_reference>
  <results_reference>
    <citation>Rosengren SM, McAngus Todd NP, Colebatch JG. Vestibular-evoked extraocular potentials produced by stimulation with bone-conducted sound. Clin Neurophysiol. 2005 Aug;116(8):1938-48. doi: 10.1016/j.clinph.2005.03.019.</citation>
    <PMID>15979939</PMID>
  </results_reference>
  <results_reference>
    <citation>Sandhu JS, George SR, Rea PA. The effect of electrode positioning on the ocular vestibular evoked myogenic potential to air-conducted sound. Clin Neurophysiol. 2013 Jun;124(6):1232-6. doi: 10.1016/j.clinph.2012.11.019. Epub 2013 Jan 18.</citation>
    <PMID>23333609</PMID>
  </results_reference>
  <results_reference>
    <citation>Todd NP, Rosengren SM, Aw ST, Colebatch JG. Ocular vestibular evoked myogenic potentials (OVEMPs) produced by air- and bone-conducted sound. Clin Neurophysiol. 2007 Feb;118(2):381-90. doi: 10.1016/j.clinph.2006.09.025. Epub 2006 Dec 1.</citation>
    <PMID>17141563</PMID>
  </results_reference>
  <results_reference>
    <citation>Welgampola MS, Carey JP. Waiting for the evidence: VEMP testing and the ability to differentiate utricular versus saccular function. Otolaryngol Head Neck Surg. 2010 Aug;143(2):281-3. doi: 10.1016/j.otohns.2010.05.024.</citation>
    <PMID>20647135</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Kathryn Makowiec</investigator_full_name>
    <investigator_title>Vestibular Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vestibulocochlear Nerve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD with other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251586
org study id: 140805
nct id: NCT03251586
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
"Test-Retest Reliability of ocular vestibular evoked myogenic potentials (oVEMPs) across
      different electrode montages."

      The purpose of this project is to compare the response characteristics of the ocular
      vestibular evoked myogenic potential in patients grouped by decade (i.e. 20's-90's) using two
      different recording montages and two different stimulus types (i.e. air and bone conducted
      sound). The long-term goal is to increase the sensitivity and specificity of the oVEMP when
      used clinically to identify vestibular disorders affecting the utricle and superior portion
      of the vestibular nerve.

      .
Specific Aim: Compare the difference in the contralateral peak-to-peak N1-P1 amplitude and N1
      latency between the belly tendon electrode montage with the conventional infraorbital
      electrode montage in otologically normal patients grouped by decade with the goal of
      developing normative values to use clinically.

      The oVEMP is a short latency (~10 ms), negative polarity evoked myogenic potential that is
      recorded from the extraocular muscles. The oVEMP test is well-tolerated by patients and is
      simple to administer. Whereas the recording of the cVEMP to air-conducted stimuli represents
      a means for evaluating the function of the saccule and inferior vestibular nerve, the oVEMP
      in response to mechanical, and probably air conducted stimuli, is now felt to represent a
      method for assessing the functional integrity of the utricle and superior vestibular nerve.

      The oVEMP response is recorded from beneath both the ipsilateral and contralateral eyes, but
      the largest response is typically seen in the contralateral recording. The contralateral
      utricular-ocular pathway terminates on the inferior oblique muscle, the electrical field of
      which can be recorded by an electrode placed at the midline of the lower lid and having the
      subject gaze upward (i.e. which results in the inferior oblique muscle becoming more
      superficial to the location of the surface electrode.

      The the absolute oVEMP N1 peak-to-peak amplitude has become the most important measurement
      for diagnostic purposes. Typical oVEMP latencies are ~11 ms for the negative peak (N1) and
      ~15 ms for the following positive peak (P1) .

      Variables that may confound recording oVEMPs include body position and electrode montages.
      Regarding electrode placement, there are three different electrode montages that have been
      studied and implemented clinically. The vast majority of clinics favor the electrode montage
      reported in the early papers describing the oVEMP. The authors reported that the
      non-inverting electrode was placed infraorbitally at the margin of the lower eyelid. The
      inverting electrode was placed 2 cm inferior to the location of the non-inverting electrode.
      Two additional electrode montages that have been reported include: 1) the noninverting
      electrodes placed at the margin of the lower eyelid slightly lateral to midline and the
      inverting electrode placed rostral to the inner canthus of the eye, and, 2) the noninverting
      electrodes placed at the middle of the lmargin of the lower eyelid and a single common
      inverting electrode placed on the chin. A report by Sandhu et al. (2013) indicated that the
      maximal oVEMP amplitude was recorded with the former electrode montage. In this montage, the
      inverting electrode is placed over a tendon, which is believed to be (relatively)
      electrically neutral.

      Skin surface electrodes are sensitive to the desired muscle activity (i.e. signal) recorded
      locally as well as non-stimulus-related electrical activity (i.e. noise) that can be both
      endogenous and exogenous. Where the signal is common to both the inverting and non-inverting
      electrodes this activity routed into a differential electrode can result in cancellation of
      some or all of the desired signal.

      Recently published data from our laboratory has shown that the Sandhu montage (i.e. the
      "belly-tendon electrode montage) in the sitting position is the optimal method for testing
      patients who are otologically and neurologically normal. This montage is associated with a
      larger N1 amplitude and a larger peak-to-peak amplitude for oVEMP measurements for young,
      normal patients. Due to the knowledge that the amplitude of the oVEMP response decreases with
      age, however, normative values based on decade would be necessary to have the oVEMP response
      be as clinically useful as possible.

      Significance and Potential of the Research:

      Establishing normative values based on decade will allow for higher sensitivity and
      specificity to vestibular impairments affecting the utricle and superior portion of the
      vestibular nerve, as well as increase the sensitivity and specificity to disorders such as
      Superior Semicircular Canal Dehiscence Syndrome.

      Methods:

      Subjects: Participants will include groups of patients between 20-90 years of age. The groups
      will be composed of 10-15 subjects per group to allow for normative data to be calculated.
      Participants will be recruited by phone using databases housed in the Odess Otolaryngology
      Department at Vanderbilt Bill Wilkerson Center, via flyers posted at Vanderbilt University
      Medical Center, and through Research Match email blasts. The study protocol will undergo
      review by the Vanderbilt Institutional Review Board (submitted-see Appendix).

      oVEMP Recording: For the oVEMP recording (utricular assessment), subjects will be seated in a
      comfortable reclining will be compared during this study. First, an electrode montage and
      recording parameters similar to those reported by Chihara et al. (2007) will be used to
      record the oVEMP. Disposable silver/silverchloride electrodes will be placed infraorbitally
      beneath each eye (i.e., infraorbital 1 cm) representing the non-inverting amplifier inputs
      and 3cm infraorbitally will serve as the location for the inverting electrode. A second
      electrode montage with recording parameters similar those reported by Sandhu et al. (2013)
      will be used simultaneously to record oVEMP responses. Disposable silver/silverchloride
      electrodes will be placed on the belly of the inferior oblique muscle representing the
      non-inverting amplifier inputs and the tendon of the inferior oblique muscle will serve as
      the location for the inverting electrode. The ground electrode will be placed at Fpz for both
      electrode montages.

      When recording the oVEMP, the subjects will be seated and instructed to keep their head at
      midline and gaze at a target positioned ~30° upward at midline. During the recording, the
      investigator will monitor to ensure the subject's chin is parallel to the horizon. Stimuli
      for the oVEMP recordings will be presented monaurally through Etymotic ER-3A insert earphones
      or a B81 bone conductor and consist of 500 Hz tone bursts presented at a rate of 5.1/sec. The
      tone burst will have a 2 cycle rise time, 1 cycle plateau and a 2 cycle fall time. A
      Neuroscan (Herndon, UA) multi-channel evoked potential recording system will enable us to
      record simultaneously the oVEMP response from each of the two electrode montages. EMG
      activity will be amplified by 100,000 times and signal averaged over 100 msec. A minimum of
      120 individual samples will be collected for each recording. Each tracing will be replicated
      at least one time so that the waveform reproducibility can be estimated. Order effects will
      be eliminated by counterbalancing the order of the starting ear. oVEMPs from the two
      electrode montages will be recorded simultaneously, so counterbalancing the electrode montage
      will be unnecessary. A minimum of two amplitude measures will be completed for each electrode
      montage condition in each position, for a total minimum of 8 recordings per subject. The
      subject will be given 1-2 minutes to rest their eyes between recordings.

      Stimulus level will be calibrated in dBpeak SPL using a 2-cm3 coupler to a sound-level meter
      (Bruel & Kjaer). The stimulus waveforms and amplitude spectra will be measured by routing the
      air conduction output of the sound-level meter to a spectrum analyzer.

      Statistical Methods:

      Analysis: Summary statistics will be provided for all demographic and clinical variables,
      along with 95% confidence intervals and side-by-side boxplots. Between-group differences in
      categorical variables will be assessed via chi-squared tests while differences in continuous
      variables will be assessed via the Wilcoxin rank-sum test (using significance level alpha =
      0.0125 in primary analysis as per the power calculation above). Hotelling's T-squared
      distribution will also be used as an omnibus or simultaneous test that the groups are the
      same for all variables in the primary analysis. Amplitude differences obtained using each
      montage will be calculated as a change expressed in percentage using the formula below:

      (n1-p1 amplitude montage2 - n1-p1 amplitude montage 1)

      --------------------------------------------------------------- n1-p1 amplitude montage 1

      All statistical analyses will be performed with SPSS 23.

      Facilities Available: The Vanderbilt Balance Disorders Laboratory is located in the Bill
      Wilkerson Center. The Balance Disorders Laboratory is equipped with state-of-the art
      equipment for comprehensive assessment of vestibular and auditory disorders. The facility
      includes a sound treated room, five diagnostic audiometers, five compact disk players for
      speech audiometry, five immittance meters, three otoacoustic emissions devices, two rotary
      vestibular test chairs, three videonystagmography systems, a computerized
      electronystagmography system, a computerized dynamic posturography system, a Neuroscan evoked
      response system with capability for 64 channel simultaneous brain signal acquisition, and 4
      2-channel clinical evoked potentials systems.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Development of Normative Values per Decade
time frame: 5 months for data collection, one visit per subject.
description: The oVEMP N1-P1 amplitude and N1 latency will be measured for each subject and will be used to calculate normative values for each decade. The goal is to provide clinics with normative information to base clinical evaluations on.
arm group label: 20-29
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 30-39
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 40-49
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 50-59
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 60-69
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 70-79
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 80-89
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
arm group label: 90-99
arm group type: Experimental
description: Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
intervention type: Diagnostic Test
intervention name: oVEMP - infra-orbital electrode montage
description: oVEMPs are short latency (~10 ms) stimulus-synchronized extra-ocular muscle reflexes produced in response to appropriate stimuli. The response is believed to originate from excitation of the utricular macula with the subsequent neural response relayed to the brain by the superior portion of the vestibular nerve. Changes in the electrical field of the contralateral inferior oblique muscle can be recorded by an electrode placed at the infra-ocular midline of the lower lid while having the subject gaze upward. The conventional electrode montage, the infra-orbital electrode montage, has the active electrode placed directly inferior to the eye and the reference electrode placed 2-3 cm below the active on the cheek. This electrode montage may result in reference contamination, which will cause an artificially reduced amplitude response, as a portion of the response can be measured by the reference electrode.
arm group label: 20-29
arm group label: 30-39
arm group label: 40-49
arm group label: 50-59
arm group label: 60-69
arm group label: 70-79
arm group label: 80-89
arm group label: 90-99
intervention type: Diagnostic Test
intervention name: oVEMP - belly-tendon electrode montage
description: oVEMPs are short latency (~10 ms) stimulus-synchronized extra-ocular muscle reflexes produced in response to appropriate stimuli. The response is believed to originate from excitation of the utricular macula with the subsequent neural response relayed to the brain by the superior portion of the vestibular nerve. Changes in the electrical field of the contralateral inferior oblique muscle can be recorded by an electrode placed at the infra-ocular midline of the lower lid while having the subject gaze upward. The belly-tendon electrode montage consists of an active electrode placed laterally to the midline of the lower eyelid and a reference electrode placed on the inner canthus. This reference location is believed to be electrically neutral, and should therefore result in larger amplitude responses as the response would not be subject to reference contamination.
arm group label: 20-29
arm group label: 30-39
arm group label: 40-49
arm group label: 50-59
arm group label: 60-69
arm group label: 70-79
arm group label: 80-89
arm group label: 90-99
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn F Makowiec, AuD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
citation: Chang CM, Cheng PW, Wang SJ, Young YH. Effects of repetition rate of bone-conducted vibration on ocular and cervical vestibular-evoked myogenic potentials. Clin Neurophysiol. 2010 Dec;121(12):2121-7. doi: 10.1016/j.clinph.2010.05.013. Epub 2010 Jun 11.
PMID: 20541460
citation: Chihara Y, Iwasaki S, Ushio M, Murofushi T. Vestibular-evoked extraocular potentials by air-conducted sound: another clinical test for vestibular function. Clin Neurophysiol. 2007 Dec;118(12):2745-51. doi: 10.1016/j.clinph.2007.08.005. Epub 2007 Oct 1.
PMID: 17905655
citation: Curthoys IS, Iwasaki S, Chihara Y, Ushio M, McGarvie LA, Burgess AM. The ocular vestibular-evoked myogenic potential to air-conducted sound; probable superior vestibular nerve origin. Clin Neurophysiol. 2011 Mar;122(3):611-616. doi: 10.1016/j.clinph.2010.07.018. Epub 2010 Aug 14.
PMID: 20709596
citation: Govender S, Rosengren SM, Colebatch JG. The effect of gaze direction on the ocular vestibular evoked myogenic potential produced by air-conducted sound. Clin Neurophysiol. 2009 Jul;120(7):1386-91. doi: 10.1016/j.clinph.2009.04.017. Epub 2009 May 22.
PMID: 19464947
citation: Makowiec K, McCaslin DL, Jacobson GP, Hatton K, Lee J. Effect of Electrode Montage and Head Position on Air-Conducted Ocular Vestibular Evoked Myogenic Potential. Am J Audiol. 2017 Jun 13;26(2):180-188. doi: 10.1044/2017_AJA-16-0108.
PMID: 28520834
citation: Kantner C, Gurkov R. Characteristics and clinical applications of ocular vestibular evoked myogenic potentials. Hear Res. 2012 Dec;294(1-2):55-63. doi: 10.1016/j.heares.2012.10.008. Epub 2012 Oct 30.
PMID: 23123220
citation: Murnane OD, Akin FW, Kelly KJ, Byrd S. Effects of stimulus and recording parameters on the air conduction ocular vestibular evoked myogenic potential. J Am Acad Audiol. 2011 Jul-Aug;22(7):469-80. doi: 10.3766/jaaa.22.7.7.
PMID: 21993052
citation: Nguyen KD, Welgampola MS, Carey JP. Test-retest reliability and age-related characteristics of the ocular and cervical vestibular evoked myogenic potential tests. Otol Neurotol. 2010 Jul;31(5):793-802. doi: 10.1097/MAO.0b013e3181e3d60e.
PMID: 20517167
citation: Piker EG, Jacobson GP, McCaslin DL, Hood LJ. Normal characteristics of the ocular vestibular evoked myogenic potential. J Am Acad Audiol. 2011 Apr;22(4):222-30. doi: 10.3766/jaaa.22.4.5.
PMID: 21586257
citation: Piker EG, Jacobson GP, Burkard RF, McCaslin DL, Hood LJ. Effects of age on the tuning of the cVEMP and oVEMP. Ear Hear. 2013 Nov-Dec;34(6):e65-73. doi: 10.1097/AUD.0b013e31828fc9f2.
PMID: 23673615
citation: Rosengren SM, McAngus Todd NP, Colebatch JG. Vestibular-evoked extraocular potentials produced by stimulation with bone-conducted sound. Clin Neurophysiol. 2005 Aug;116(8):1938-48. doi: 10.1016/j.clinph.2005.03.019.
PMID: 15979939
citation: Sandhu JS, George SR, Rea PA. The effect of electrode positioning on the ocular vestibular evoked myogenic potential to air-conducted sound. Clin Neurophysiol. 2013 Jun;124(6):1232-6. doi: 10.1016/j.clinph.2012.11.019. Epub 2013 Jan 18.
PMID: 23333609
citation: Todd NP, Rosengren SM, Aw ST, Colebatch JG. Ocular vestibular evoked myogenic potentials (OVEMPs) produced by air- and bone-conducted sound. Clin Neurophysiol. 2007 Feb;118(2):381-90. doi: 10.1016/j.clinph.2006.09.025. Epub 2006 Dec 1.
PMID: 17141563
citation: Welgampola MS, Carey JP. Waiting for the evidence: VEMP testing and the ability to differentiate utricular versus saccular function. Otolaryngol Head Neck Surg. 2010 Aug;143(2):281-3. doi: 10.1016/j.otohns.2010.05.024.
PMID: 20647135
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Kathryn Makowiec
investigator title: Vestibular Fellow
mesh term: Vestibulocochlear Nerve Diseases
sharing ipd: No
ipd description: There is no plan to share IPD with other researchers.