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Contact Information:

Mr Richard Irving
+44 (0)121 371 4928
Richard.Irving@uhb.nhs.uk


Dr Raymond Reynolds
+44 (0)121 414 4107
r.f.reynolds@bham.ac.uk


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Be Part of Research - Trial Details - A new diagnostic for vestibular balance dysfunction
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A new diagnostic for vestibular balance dysfunction

Recruiting

Open to: All Genders

Age: Adult

Birmingham Edgbaston

Medical Conditions

Vestibular dysfunction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The vestibular system is the part of the inner ear used to maintain balance. When it goes wrong this can lead to dizziness, loss of balance and blurred vision. It is therefore important to be able to test vestibular function accurately. The purpose of this research is to develop a faster, better vestibular test called electrical vestibular stimulation (EVS). EVS involves a very small electrical stimulus delivered behind the ears. This causes an eye movement which we record with a camera. This study will compare the accuracy of EVS with three other existing diagnostic tests: caloric irrigation, vestibular-evoked myogenic potentials (VEMPs) and the video head impulse test (vHIT).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Mar 2024 30 Apr 2027

The study will involve a single visit to the School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham. It will last about 3 ½ hours (including breaks) during which the participant will experience the following tests of vestibular function, all of which are non-invasive.
1. Electrical Vestibular Stimulation (EVS)
EVS is a safe and painless method of testing inner ear function. Two electrodes will be placed on the skin immediately behind your ears. A very small current (up to ~5 mA and 30 s duration) is then passed between the electrodes to produce eye movements. You may feel this current on your skin as a tingling sensation, but it should not be painful. All volunteers will be given an initial test of the stimulus before being asked if they are happy to continue. We record the eye movement in darkness using an infrared camera. This test lasts about 30 minutes.
2. Caloric Irrigation
Caloric irrigation is an established test of inner ear function which you may have experienced previously in clinic. It involves either cool (30O oC) or warm (44O oC) water being poured into the external ear canal while you lie on a couch. Calorics evoke a spinning sensation and an eye movement which we will record by camera. This test lasts about 40 minutes.
3. Video Head Impulse Testing (vHIT)
vHIT involves very small rotations of the head. The experimenter will hold your head with their hands on either side and produce small fast rotations of the head. The resulting eye movement will be measured using small lightweight goggles with cameras. This test lasts 5-10 minutes.
4. Vestibular-Evoked Myogenic Potentials (VEMPs)
VEMPs are a technique for assessing the function of the otolith organs (a part of the vestibular system). Small recording electrodes are placed on the skin over the neck muscles or around the eyes. Very brief tones are then delivered through headphones or bone-conducted vibrations. This test lasts about 45 minutes.


Patients aged 18 years and over diagnosed with unilateral vestibular schwannoma (VS), Ménière’s disease, and patients attending ENT clinic with suspected but undiagnosed peripheral vestibular disorders. Healthy control volunteers over 18 years old will also participate in the study as controls.

You can take part if:



You may not be able to take part if:


1. Other afflictions which may affect the control of balance and vestibular function e.g. neurological conditions such as stroke, Parkinson's disease, cerebellar ataxia, dementia.2. Electronic implants (including cochlear implants, pacemakers and bone-anchored hearing aids)3. Uncontrolled heart disease or uncontrolled mental illness4. Any patient with eardrum perforation or other damage/infection of the outer ear will be excluded from caloric irrigation5. Any patient with severe tinnitus will be excluded from air-conducted VEMPs6. Any patients with neck pain will be excluded from vHIT


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital Birmingham
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2WB
  • University of Birmingham
    School of Sport, Exercise and Rehabilitation Science
    Edgbaston
    B15 2TT

There is unlikely to be any direct benefit for the participants. The main purpose of the project is to help with the diagnosis of future patients once EVS has been fully validated.
Caloric irrigation, VEMPs and vHIT are regularly used in hospital clinics. Caloric irrigation can exacerbate any pre-existing outer ear problems such as a perforated eardrum. To avoid such issues, we will carefully examine the outer ear using an otoscope. Caloric irrigation can cause a spinning sensation, and this is occasionally accompanied by feelings of dizziness or nausea. However, this usually subsides within a minute or two of stopping the test.
Since calorics can induce a strong spinning sensation, exclusion criteria will include uncontrolled heart disease or mental illness. vHIT involves small manual rotations of the head. Anyone with neck pain/damage will be excluded from vHIT. VEMPs involve bone/air-conducted sound while recording muscle activity and carry no specific risks
EVS itself is a safe technique which has been applied to humans for many years for research. We use a CE-marked stimulator approved for use on human participants. EVS can sometimes cause discomfort at the site of the stimulating electrode behind the ear. However, this is usually alleviated by repositioning the electrode. All participants will be given a test stimulus at the beginning of the session to check that they are happy to continue.
Since these interventions all carry low risk, it is unlikely that any patient will experience any lasting ill effects (other than their existing illness).

Mr Richard Irving
+44 (0)121 371 4928
Richard.Irving@uhb.nhs.uk


Dr Raymond Reynolds
+44 (0)121 414 4107
r.f.reynolds@bham.ac.uk



The study is sponsored by University of Birmingham and funded by Medical Research Council.



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Read full details for Trial ID: ISRCTN11391023

Or CPMS 58768

Last updated 16 December 2024

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