- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03049683
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The combined evaluation of ocular and cervical VEMPs permits the assessment of both endorgans and whole vestibular nerve function, as well as the ascending and descending vestibular pathways in the brainstem at once.
In about 30 healthy participants and 20 patients with acute unilateral vestibular neuritis, unilateral simultaneous cVEMP and oVEMP recordings in each side during monaural stimulation (air-conducted sound, 500Hz tone bursts, 100 nHL), and bilateral simultaneous recordings of each VEMP while binaural stimulation were compared to the conventional method of sequential recording each VEMPs on each side at a time.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- a previous history of vertigo or neuro-otologic diseases
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time Frame: 6 months
|
The changes in the mean time for each recording
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time Frame: 6 months
|
VEMP parameters: latency
|
6 months
|
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time Frame: 6 months
|
VEMP parameters: peak-to-peak amplitude
|
6 months
|
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time Frame: 6 months
|
VEMP parameters: threshold
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChonbukNU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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