Vestibular NeuronitisNCT02463695
Characterisation of Cortical Vestibular Evoked Potentials (C-VEPs)
A study testing cortical vestibular evoked potentials (CVEPs) in people with Vestibular Neuronitis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The pathophysiology of vertigo is complex and usually requires specialist involvement. During the diagnostic process, patients commonly undergo tests which assess the integrity of the gaze and posture stabilisation mechanisms involving the inner ear (vestibular system), the visual systems and the subconscious neural… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Neuronitis
- What is being tested?
- cortical vestibular evoked potentials (CVEPs)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2014to 31 Aug 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vestibular deficit Group:
- Over 18 years of age
- Can provide informed consent
- Deemed to have an otoneurological cause for their symptoms (true vertigo, room spinning even when head is still)
- No middle ear pathology
- NORMATIVE GROUP:
Show all 9Show fewer
- Over 18 years of age
- Can provide informed consent
- No previous otoneurological history
Who cannot join
- VESTIBULAR DEFICIT GROUP PATIENTS
- Participants under the age of 18
- Participants unable to provide informed consent
- Patients not deemed to have an otoneurological cause for their symptoms
- Patients with middle ear pathology
- NORMATIVE GROUP:
Show all 9Show fewer
- Previous history of problems with hearing and or balance
- Participants under the age of 18
- Participants unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Characterisation of Cortical Vestibular Evoked Potentials (C-VEPs): A Comparative Study of Normal Ears Versus Those With Vestibular Deficits
The pathophysiology of vertigo is complex and usually requires specialist involvement. During the diagnostic process, patients commonly undergo tests which assess the integrity of the gaze and posture stabilisation mechanisms involving the inner ear (vestibular system), the visual systems and the subconscious neural pathways that interconnect them. Whilst these tests are useful they fail to provide information concerning the neural connections to the cortex and therefore neglect the perceptual aspects of disequilibrium.
At present the possibility of routine examination of these higher projections remains elusive as no practical alternatives to the expensive functional magnetic resonance imaging systems exist. However, recently a novel method of recording cortical vestibular evoked potentials (CVEPs) has been described.
Read more
CVEPs utilise an existing method used to interrogate cortical projections from the auditory system in which sound waves stimulate the inner ear and the resulting electrical responses from the brain are recorded. The recent breakthrough is in the realisation that these responses also contain information from the balance organs and therefore are a direct measure of cortical processing of the vestibular inputs.
Current evidence shows that CVEPs are present in the normal population and absent in patients with no vestibular function. The primary aim for this study is to extend the patient cohort to include those who have a vestibular injury but retain residual function. Patients going through standard testing will have also have CVEPs on both ears providing seminal information into the effect of injury to the peripheral vestibular system on the cortical pathways. Furthermore, by following the cohort through their complete management pathway it will be possible to ascertain if the CVEP can be used to predict rehabilitation outcome success.
Read the detailed description
Ears with a vestibular deficit:
Patients referred to the tertiary ear nose and throat clinics as well otoneurological clinics at the Royal Hallamshire will be eligible for enrolment. The investigators aim to record data from 36 ears with vestibular dysfunction.
- Patients will receive a consultation with an ENT Consultant or Registrar as per standard practice.
- If the patient is deemed by the doctor to have an otoneurological cause for their symptoms then further audiovestibular testing and imaging will be arranged as per standard practice. The patients will then be made aware of this study and if interested will be given the opportunity to discuss it further with the chief investigator (CI) or the principal investigator (PI).
- If agreeable the patients will be given information packs by the PI/CI and taken through the study.
- The patients will leave the consultation with the information pack and be asked to consider participation in the study. They will have no obligation to take part and they can contact the any member of the research team to ask for further information or to have any questions answered.
- Upon their return for audiovestibular testing the patients will inform the CI/PI if they wish to participate in the study and if so will have an additional test at the end of test sequence. This will add approximately 30 minutes to their appointment time.
- Patients who are suitable for rehabilitation (as per standard care pathway) will go ahead and have the course of treatment at subsequent visit(s). The outcomes following the treatment will be logged and correlated with the CVEP to check for any correlation that may or may not be present.
Otologically normal ears:
Normative data will be collected from 36 normal ears from subjects that have no history of audiovestibular symptoms and are not being investigated for any balance disorders. Healthy controls will be recruited via poster advertisements and potential participants asked to contact the research team if they are considering taking part.
- Conditions
- Vestibular Neuronitis
- Being tested
- cortical vestibular evoked potentials (CVEPs)
- Keywords
- partial vestibular deficit, cortical vestibular evoked potential
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cortical vestibular evoked potentials (CVEPs)Procedure or surgery
Also called Cortical auditory evoked potential
CVEPs utilise an existing method used to interrogate cortical projections from the auditory system in which sound waves stimulate the inner ear and the resulting electrical responses from the brain are recorded (known as Cortical Auditory Evoked Potentials CAEPs)
| Study group | Role | What they receive |
|---|---|---|
| vestibular deficit | Experimental | * Initial clinical assessment including otoneurological examination, pure tone audiometry, tympanometry vestibular screening tests and Magnetic Resonance Imaging as clinically indicated.
* The cortical vestibular evoked potentials will add approximately add an extra 30 minutes to the test sequence but is minimally invasive and will not cause any pain or discomfort. It will be conducted on both the affected and non-affected ears. Receives: Procedure: cortical vestibular evoked potentials (CVEPs) |
| otologically normal controll | Active comparator | Normative data will be collected from 36 normal ears from subjects that have no history of audiovestibular symptoms and are not being investigated for any balance disorders. The cortical vestibular evoked potentials will be recorded from both ears Receives: Procedure: cortical vestibular evoked potentials (CVEPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of change of cortical vestibular evoked potential measured by amplitude (in microvolts)
Measured: 6 months
Secondary outcomes (1)
The time interval between the stimulation and response (latency) of cortical vestibular evoked potential
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 posted4 Jun 2015 (estimated)
- Study start14 Oct 2014
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Why it stopped: staffing issues, no capacity in team to continue the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular NeuronitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaswinder S Sandhu, Dr, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463695
- Sponsor's protocol ID
- STH18541
- Status last verified
- Apr 2026
- First submitted
- 28 May 2015
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Cortical Vestibular Evoked Potentials (C-VEPs): A Comparative Study of Normal Ears Versus Those With Vestibular Deficits
- ClinicalTrials.gov ID
- NCT02463695
- Acronym / sponsor ID
- STH18541
- Conditions
- Vestibular Neuronitis
- Keywords
- partial vestibular deficit, cortical vestibular evoked potential
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: staffing issues, no capacity in team to continue the project
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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.
The pathophysiology of vertigo is complex and usually requires specialist involvement. During the diagnostic process, patients commonly undergo tests which assess the integrity of the gaze and posture stabilisation mechanisms involving the inner ear (vestibular system), the visual systems and the subconscious neural pathways that interconnect them. Whilst these tests are useful they fail to provide information concerning the neural connections to the cortex and therefore neglect the perceptual aspects of disequilibrium.
At present the possibility of routine examination of these higher projections remains elusive as no practical alternatives to the expensive functional magnetic resonance imaging systems exist. However, recently a novel method of recording cortical vestibular evoked potentials (CVEPs) has been described.
CVEPs utilise an existing method used to interrogate cortical projections from the auditory system in which sound waves stimulate the inner ear and the resulting electrical responses from the brain are recorded. The recent breakthrough is in the realisation that these responses also contain information from the balance organs and therefore are a direct measure of cortical processing of the vestibular inputs.
Current evidence shows that CVEPs are present in the normal population and absent in patients with no vestibular function. The primary aim for this study is to extend the patient cohort to include those who have a vestibular injury but retain residual function. Patients going through standard testing will have also have CVEPs on both ears providing seminal information into the effect of injury to the peripheral vestibular system on the cortical pathways. Furthermore, by following the cohort through their complete management pathway it will be possible to ascertain if the CVEP can be used to predict rehabilitation outcome success.
Detailed description
Ears with a vestibular deficit:
Patients referred to the tertiary ear nose and throat clinics as well otoneurological clinics at the Royal Hallamshire will be eligible for enrolment. The investigators aim to record data from 36 ears with vestibular dysfunction.
- Patients will receive a consultation with an ENT Consultant or Registrar as per standard practice.
- If the patient is deemed by the doctor to have an otoneurological cause for their symptoms then further audiovestibular testing and imaging will be arranged as per standard practice. The patients will then be made aware of this study and if interested will be given the opportunity to discuss it further with the chief investigator (CI) or the principal investigator (PI).
- If agreeable the patients will be given information packs by the PI/CI and taken through the study.
- The patients will leave the consultation with the information pack and be asked to consider participation in the study. They will have no obligation to take part and they can contact the any member of the research team to ask for further information or to have any questions answered.
- Upon their return for audiovestibular testing the patients will inform the CI/PI if they wish to participate in the study and if so will have an additional test at the end of test sequence. This will add approximately 30 minutes to their appointment time.
- Patients who are suitable for rehabilitation (as per standard care pathway) will go ahead and have the course of treatment at subsequent visit(s). The outcomes following the treatment will be logged and correlated with the CVEP to check for any correlation that may or may not be present.
Otologically normal ears:
Normative data will be collected from 36 normal ears from subjects that have no history of audiovestibular symptoms and are not being investigated for any balance disorders. Healthy controls will be recruited via poster advertisements and potential participants asked to contact the research team if they are considering taking part.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vestibular deficit | Experimental | Procedure: cortical vestibular evoked potentials (CVEPs)* Initial clinical assessment including otoneurological examination, pure tone audiometry, tympanometry vestibular screening tests and Magnetic Resonance Imaging as clinically indicated. * The cortical vestibular evoked potentials will add approximately add an extra 30 minutes to the test sequence but is minimally invasive and will not cause any pain or discomfort. It will be conducted on both the affected and non-affected ears. |
| otologically normal controll | Active comparator | Procedure: cortical vestibular evoked potentials (CVEPs)Normative data will be collected from 36 normal ears from subjects that have no history of audiovestibular symptoms and are not being investigated for any balance disorders. The cortical vestibular evoked potentials will be recorded from both ears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Vestibular deficit Group:
- Over 18 years of age
- Can provide informed consent
- No previous otoneurological history
Key exclusion criteria (9 listed)
- VESTIBULAR DEFICIT GROUP PATIENTS
- Previous history of problems with hearing and or balance
- Participants under the age of 18
- Participants unable to provide informed consent
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 |
|---|---|---|
| cortical vestibular evoked potentials (CVEPs)Also: Cortical auditory evoked potentialCVEPs utilise an existing method used to interrogate cortical projections from the auditory system in which sound waves stimulate the inner ear and the resulting electrical responses from the brain are recorded (known as Cortical Auditory Evoked Potentials CAEPs) | Procedure or surgery | otologically normal controll, vestibular deficit |
Primary outcome
The degree of change of cortical vestibular evoked potential measured by amplitude (in microvolts)
Time frame: 6 months
1 secondary outcome
The time interval between the stimulation and response (latency) of cortical vestibular evoked potential
Time frame: 6 months
Results and safety
The study was stopped early (reason given: staffing issues, no capacity in team to continue the project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
Jaswinder S Sandhu, Dr principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cortical vestibular evoked potentials (CVEPs) in people with Vestibular Neuronitis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: staffing issues, no capacity in team to continue the project). 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?
The degree of change of cortical vestibular evoked potential measured by amplitude (in microvolts) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.