Test-Retest Reliability of oVEMP's Across Different Electrode Montages

NCT03251586 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-03-15

No results posted yet for this study

Summary

"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.

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Conditions

  • Vestibular Abnormality
  • Vestibular Nerve Disorders

Interventions

DIAGNOSTIC_TEST

oVEMP - infra-orbital electrode montage

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.

DIAGNOSTIC_TEST

oVEMP - belly-tendon electrode montage

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Kathryn F Makowiec, AuD · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2018-04-30
Completion
2018-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03251586 on ClinicalTrials.gov