NCT03049683

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

December 21, 2016

Last Update Submit

February 8, 2017

Conditions

Keywords

Vestibular evoked myogenic potentials

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.

Other: Vestibular evoked myogenic potentials (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.

Other: Vestibular evoked myogenic potentials (VEMPs)

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).

Acute unilateral vestibular neuritisNormal subjects

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Vestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials, MotorEvoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological Phenomena

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