Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials
Clinical Utility of Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials During Monaural Stimulation
1 other identifier
observational
60
0 countries
N/A
Brief Summary
To lower the threshold for clinical application by reducing the testing time for recording vestibular-evoked myogenic potentials (VEMPs), we evaluated whether a simultaneous recording of ocular and cervical VEMPs after unilateral or bilateral stimulation can be achieved without a loss in diagnostic sensitivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
Shorter than P25 for all trials
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
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 10, 2017
February 1, 2017
5 months
December 21, 2016
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
The changes in the mean time for each recording
6 months
Secondary Outcomes (3)
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
6 months
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
6 months
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
6 months
Study Arms (2)
Normal subjects
Thirty healthy volunteers without a previous history of vertigo or neuro-otologic diseases will be enrolled in this study. The subjects will be also screened with a full history on vestibular disorders, with pure tone audiogram, and head-impulse tests to exclude the possibility of previous vestibular disorders or migraine which may cause abnormal VEMPs.
Acute unilateral vestibular neuritis
The criteria for inclusion as a patient with vestibular neuritis involving the superior division (superior VN) included the following: (1) acute onset of vertigo, (2) the appearance of mixed horizontal and torsional nystagmus, (3) impaired horizontal semicircular canal (SCC) function on head-impulse test and a unilaterally absent or reduced caloric response (i.e., a caloric paresis score \> 25%), (4) intact inferior division of vestibular nerve as evidenced by normal cVEMP and normal head-impulse test for vertical SCCs, and (5) the absence of auditory and neurologic signs. Thirty patients (aged 32-82 years; mean age, 51.7 years; 16 males) fulfilled the criteria of superior VN.
Interventions
The c- and oVEMPs will be assessed in three different sessions including conventional sequential recordings and two different simultaneous recording methods, i.e., unilateral simultaneous recording of cVEMPs and oVEMPs during monaural stimulation (Figure 1A) and bilateral simultaneous recording of each VEMP during binaural stimulation (Figure 1B).
Eligibility Criteria
About thirty healthy volunteers without a previous history of vertigo or neuro-otologic diseases will be enrolled in this study. The subjects were also screened with a full history on vestibular disorders, with pure tone audiogram, and head-impulse tests to exclude the possibility of previous vestibular disorders or migraine which may cause abnormal VEMPs. The criteria for inclusion as a patient with vestibular neuritis involving the superior division (superior VN) will be included the following: (1) acute onset of vertigo, (2) the appearance of mixed horizontal and torsional nystagmus, (3) impaired horizontal semicircular canal (SCC) function on head-impulse test and a unilaterally absent or reduced caloric response (i.e., a caloric paresis score \> 25%), (4) intact inferior division of vestibular nerve as evidenced by normal cVEMP and normal head-impulse test for vertical SCCs, and (5) the absence of auditory and neurologic signs.
You may qualify if:
- acute onset of vertigo
- the appearance of mixed horizontal and torsional nystagmus
- impaired horizontal semicircular canal (SCC) function on head-impulse test and a unilaterally absent or reduced caloric response (i.e., a caloric paresis score \> 25%)
- intact inferior division of vestibular nerve as evidenced by normal cVEMP and normal head-impulse test for vertical SCCs
- the absence of auditory and neurologic signs
You may not qualify if:
- a previous history of vertigo or neuro-otologic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Oh SY, Shin HJ, Boegle R, Ertl M, Eulenburg PZ, Kim JS, Dieterich M. Simultaneous recording of cervical and ocular vestibular-evoked myogenic potentials. Neurology. 2018 Jan 16;90(3):e230-e238. doi: 10.1212/WNL.0000000000004835. Epub 2017 Dec 20.
PMID: 29263227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 21, 2016
First Posted
February 10, 2017
Study Start
October 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
February 10, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share