Vestibular Function DisorderNCT03049683
Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials
An observational study of Vestibular Function Disorder, run by Chonbuk National University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Disorder
- What is being tested?
- Vestibular evoked myogenic potentials (VEMPs)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- a previous history of vertigo or neuro-otologic diseases
About this study
Official title: Clinical Utility of Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials During Monaural Stimulation
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.
Read the 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.
- Conditions
- Vestibular Function Disorder
- Being tested
- Vestibular evoked myogenic potentials (VEMPs)
- Keywords
- Vestibular evoked myogenic potentials
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular evoked myogenic potentials (VEMPs)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Vestibular evoked myogenic potentials (VEMPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
VEMP parameters: latency
Measured: 6 months
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
VEMP parameters: peak-to-peak amplitude
Measured: 6 months
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
VEMP parameters: threshold
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startOct 2016
- Primary completion1 Mar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular Function DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun-Young Oh, Chonbuk National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049683
- Sponsor's protocol ID
- ChonbukNU
- Status last verified
- Feb 2017
- First submitted
- 21 Dec 2016
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29263227
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials During Monaural Stimulation
- ClinicalTrials.gov ID
- NCT03049683
- Acronym / sponsor ID
- ChonbukNU
- Conditions
- Vestibular Function Disorder
- Keywords
- Vestibular evoked myogenic potentials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chonbuk National UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | Other: Vestibular evoked myogenic potentials (VEMPs)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 | – | Other: Vestibular evoked myogenic potentials (VEMPs)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. |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- a previous history of vertigo or neuro-otologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular evoked myogenic potentials (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). | Other | Acute unilateral vestibular neuritis, Normal subjects |
Primary outcome
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
3 secondary outcomes
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time frame: 6 months
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time frame: 6 months
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Derived from this study: PubMed 29263227Oh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Function Disorder, run by Chonbuk National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical utility of simultaneous recordings of cervical and ocular vestibular-evoked myogenic potentials during monaural stimulation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.