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临床试验/NCT03251586
NCT03251586撤回不适用

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

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家开始时间: 2018年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Development of Normative Values per Decade

研究概览

简要总结

"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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详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Normal hearing and no history of balance disorders

排除标准

  • Hearing loss, a large amount of ear wax, inner ear of balance problems, and/or no recordable eye muscle responses

研究组 & 干预措施

20-29

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

20-29

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

30-39

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

30-39

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

40-49

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

40-49

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

70-79

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

50-59

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

50-59

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

60-69

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

60-69

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

70-79

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

80-89

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

80-89

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

90-99

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - infra-orbital electrode montage (Diagnostic Test)

90-99

Experimental

Participants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.

干预措施: oVEMP - belly-tendon electrode montage (Diagnostic Test)

结局指标

主要结局

Development of Normative Values per Decade

时间窗: 5 months for data collection, one visit per subject.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn Makowiec

Vestibular Fellow

Vanderbilt University Medical Center

研究点 (2)

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