Study Stopped
Due to time constraints, the study will not be able to be completed as outlined
Test-Retest Reliability of oVEMP's Across Different Electrode Montages
1 other identifier
interventional
N/A
1 country
1
Brief 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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 15, 2018
March 1, 2018
Same day
August 11, 2017
March 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Development of Normative Values per Decade
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.
5 months for data collection, one visit per subject.
Study Arms (8)
20-29
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
30-39
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
40-49
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
50-59
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
60-69
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
70-79
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
80-89
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
90-99
EXPERIMENTALParticipants within the above age range who have normal hearing and no history of balance disorders or unsteadiness.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Normal hearing and no history of balance disorders
You may not qualify if:
- Hearing loss, a large amount of ear wax, inner ear of balance problems, and/or no recordable eye muscle responses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (14)
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: 20541460RESULTChihara 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: 17905655RESULTCurthoys 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: 20709596RESULTGovender 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: 19464947RESULTMakowiec 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: 28520834RESULTKantner 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: 23123220RESULTMurnane 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: 21993052RESULTNguyen 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: 20517167RESULTPiker 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: 21586257RESULTPiker 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: 23673615RESULTRosengren 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: 15979939RESULTSandhu 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: 23333609RESULTTodd 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: 17141563RESULTWelgampola 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: 20647135RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn F Makowiec, AuD
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vestibular Fellow
Study Record Dates
First Submitted
August 11, 2017
First Posted
August 16, 2017
Study Start
April 1, 2018
Primary Completion
April 1, 2018
Study Completion
May 1, 2018
Last Updated
March 15, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD with other researchers.