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TerminatedNCT02463695Updated Apr 29, 2026

Characterisation of Cortical Vestibular Evoked Potentials (C-VEPs)

An interventional study of cortical vestibular evoked potentials (CVEPs) in Vestibular Neuronitis, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

Why this study was terminated
staffing issues, no capacity in team to continue the project

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2014, registered May 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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.

A) Patients will receive a consultation with an ENT Consultant or Registrar as per standard practice.

B) 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).

C) If agreeable the patients will be given information packs by the PI/CI and taken through the study.

D) 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.

E) 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.

F) 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.

02

Conditions studied

  • Vestibular Neuronitis

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Keywords

  • partial vestibular deficit
  • cortical vestibular evoked potential
03

In context

Vestibular Neuronitis

34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.

This study's planned enrollment of 51 is close to the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.

Browse Vestibular Neuronitis studies →

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 214 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Vestibular deficit Group:

    1. Over 18 years of age
    2. Can provide
    3. Deemed to have an otoneurological cause for their symptoms (true vertigo, room spinning even when head is still)
    4. No middle ear pathology

NORMATIVE GROUP:

  1. Over 18 years of age
  2. Can provide informed consent
  3. No previous otoneurological history

Exclusion criteria

Exclusion Criteria:

  • VESTIBULAR DEFICIT GROUP PATIENTS

    1. Participants under the age of 18
    2. Participants unable to provide
    3. Patients not deemed to have an otoneurological cause for their symptoms
    4. Patients with middle ear pathology

NORMATIVE GROUP:

  1. Previous history of problems with hearing and or balance
  2. Participants under the age of 18
  3. Participants unable to provide informed consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    vestibular deficit

    * 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.

    Procedure: cortical vestibular evoked potentials (CVEPs)

  • Active comparator
    otologically normal controll

    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

    Procedure: cortical vestibular evoked potentials (CVEPs)

Interventions

  • Procedurecortical vestibular evoked potentials (CVEPs)

    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)

    Also known as: Cortical auditory evoked potential

06

What researchers measure

Primary outcomes

  1. The degree of change of cortical vestibular evoked potential measured by amplitude (in microvolts)

    Time frame: 6 months

Secondary outcomes

  1. The time interval between the stimulation and response (latency) of cortical vestibular evoked potential

    Time frame: 6 months

07

Study locations

1 site
  • Sheffield Teaching Hospitals NHS Trust
    Sheffield, South Yorkshire S10 2JF, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02463695
Responsible party
Sponsor
First posted
Jun 4, 2015
Start date
Oct 14, 2014
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016
Last update
Apr 29, 2026

Study contacts

Jaswinder S Sandhu, Dr
principal investigator · Sheffield Teaching Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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