Characterisation of Cortical Vestibular Evoked Potentials (C-VEPs)

NCT02463695 | Terminated

• 1 other identifier: STH18541
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vestibular Neuronitis

Keywords

partial vestibular deficit; cortical vestibular evoked potential

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

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.

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

Procedure: cortical vestibular evoked potentials (CVEPs)

Interventions

cortical vestibular evoked potentials (CVEPs) PROCEDURE

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

otologically normal controll; vestibular deficit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Over 18 years of age
• Can provide informed consent
• No previous otoneurological history

You may not qualify if:

• 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:
• Previous history of problems with hearing and or balance
• Participants under the age of 18
• Participants unable to provide informed consent

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Vestibular Neuronitis

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Jaswinder S Sandhu, Dr

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 4, 2015
• Study Start: October 14, 2014
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GB (1)