RecruitingOBSERVATIONAL

Imaging of Endolymphatic Hydrops at 7T MRI

This study is investigating new ways to use MRI scans to improve the diagnosis of Meniere's disease. Meniere's disease is an inner ear condition that can cause dizzy spells, ringing in the ears, and hearing loss. Currently, it's hard to diagnose because symptoms can come and go, and there isn't one simple test. This research aims to see if very powerful 7T MRI scans using a special technique, or standard 1.5T and 3T MRI scans with a dye, can pinpoint a specific change in the inner ear called 'endolymphatic hydrops'. This change is thought to be a key part of Meniere's disease. By comparing these different scanning methods, doctors hope to find a better way to diagnose and understand the condition.

At a glance

Status

Recruiting

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

01 Jul 2023

Estimated completion

01 Jul 2026

Meniere Disease

What is this study about?

Meniere's disease is a problem with the inner ear that can cause a range of symptoms, including hearing loss that comes and goes, ringing in the ears (tinnitus), and sudden attacks of dizziness. It can be a very challenging condition to live with, and diagnosing it can be tricky. This is because there isn't one single test that confirms Meniere's disease, and symptoms can vary greatly from person to person and even over time.

Doctors believe that a key feature of Meniere's disease is something called 'endolymphatic hydrops'. This happens when fluid builds up in certain parts of the inner ear. Think of it like a tiny balloon inside your ear swelling up. While doctors have known about this for a long time, it's been difficult to see this fluid buildup clearly in living patients. This study is exploring if modern MRI scanning techniques, particularly very powerful 7T MRI scans and others using a special dye, can show this fluid buildup more accurately.

The main goal is to compare how well these different MRI scans can detect 'endolymphatic hydrops' and help doctors tell the difference between an ear affected by Meniere's disease and one that isn't. Researchers will look at scans from both 1.5T and 3T MRI machines (which are more common) and compare them with the advanced 7T MRI scans. The hope is that improved scanning methods could lead to a clearer diagnosis for patients and a better understanding of their condition.

Key takeaways

Aims to improve diagnosis of Meniere's disease.
Compares advanced 7T MRI with standard 1.5T/3T MRI scans.
Focuses on detecting fluid build-up in the inner ear ('endolymphatic hydrops').
Study duration is 24 months, involving several MRI appointments.
You continue your existing Meniere's disease treatment.
Contributes to a better understanding of Meniere's for future patients.

Who may be eligible?

This study is looking for volunteers who are aged 18 or over and have been diagnosed with Meniere's disease that affects only one ear. This diagnosis must meet specific 2015 Bárány criteria and have started less than five years ago. Participants must also be able to understand the study information and give their permission in writing.

There are some reasons why someone might not be able to join. For example, if you have certain conditions that prevent you from having an MRI scan, or if you are allergic to the special dye sometimes used in MRI scans. People who have had previous ear surgery, ear injuries, or other known ear problems, or those with severe kidney issues, would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Meniere's disease that affects only one ear?
Has your Meniere's disease started less than 5 years ago?
Are you able to have an MRI scan (e.g., no metal implants, no severe claustrophobia)?
Do you not have a known allergy to common MRI dyes?
Have you not had previous ear surgery or major ear injuries?

Answer every question to see your result.

What does participation involve?

If you take part in this study, your involvement will last for 24 months (two years). During this time, you will have several MRI scans. These scans are a key part of the study as researchers are comparing different types of MRI technology. You will likely have scans on a standard 1.5T or 3T MRI machine, which may involve having a special dye injected into your arm to help certain parts of your ear show up more clearly. You will also have a scan on a more powerful 7T MRI machine, which uses a different technique to gather information.

The study involves attending appointments for these scans. There won't be any new medication given as part of this study; it's purely focused on improving imaging. You will continue with any treatment for Meniere's disease that your doctor has already prescribed.

Potential risks and benefits

Taking part in a research study always involves a balance of potential benefits and risks. For this study, potential benefits could include contributing to a better understanding and diagnosis of Meniere's disease, which could help future patients. You might also gain a more detailed picture of your own inner ear. Potential risks are generally low, mainly related to the MRI scans themselves, such as claustrophobia or, for some scans, a small risk of reaction to the contrast dye. It's important to remember that you are free to withdraw from the study at any time without having to give a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

King's College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'endolymphatic hydrops'?

It's a build-up of fluid in the inner ear, which doctors believe is linked to Meniere's disease.

What is an MRI scan?

MRI uses strong magnets and radio waves to create detailed pictures of the inside of your body without using X-rays.

Why is this study using different types of MRI?

Researchers want to compare how well powerful 7T MRI and standard 1.5T/3T MRI scans can show the inner ear changes related to Meniere's disease.

Will I get treatment for my Meniere's as part of the study?

This study focuses on improving diagnosis through scans, not new treatments. You'll continue your current care.

How long will I be involved in the study?

Your participation in the study will last for two years (24 months).

How to find out more

Stephen EJ Connor, MRCP FRCR

steve.connor@nhs.net 07816882304 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.