Not yet recruitingNAINTERVENTIONAL

Transcutaneous Vagus Nerve Stimulation for Ventricular Arrhythmias

This study is investigating a new treatment for irregular heartbeats that come from the lower chambers of the heart, known as ventricular arrhythmias. These can cause symptoms or even be serious. We're testing a gentle electrical stimulation applied to a part of the ear, called Low-Level Tragus Stimulation (LLTS). This method helps balance nerve activity in your heart, similar to how it's been used safely for other conditions. We want to see if LLTS can reduce these irregular heartbeats. Patients will try both the real treatment and a 'dummy' treatment, and we'll compare the results. This research could offer a new, safe way to manage these heart conditions.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

15 Jun 2025

Estimated completion

31 Dec 2027

Premature Ventricular Complexes Ventricular Tachycardia (VT)Ventricular Arrhythmias

What is this study about?

This study is about a type of irregular heartbeat that starts in the lower parts of your heart. These are called ventricular arrhythmias. Sometimes they happen just now and then, and are called PVCs (Premature Ventricular Contractions). Other times, they can happen very quickly and continuously, which is called Ventricular Tachycardia (VT). Both types can make you feel unwell, and VT can be quite serious.

Your heart's rhythm is controlled by your nervous system. Sometimes, one part of this system, called the 'sympathetic nervous system,' can become overactive, leading to these irregular heartbeats. This study is testing a gentle way to calm this down using something called Low-Level Tragus Stimulation (LLTS). It involves a small device, like a TENS machine, with an ear clip you wear for about an hour a day. This device sends very mild electrical signals to a nerve in your ear (the vagus nerve), which helps to balance your nervous system. This approach has been used safely for many years for other medical conditions, like epilepsy, so we know it's generally very safe and well-tolerated.

We want to find out if this gentle ear stimulation can help reduce the number of irregular heartbeats people experience. If it works, it could offer a simple, non-invasive (meaning it doesn't involve surgery or needles) way to manage these heart rhythm problems, potentially improving your quality of life. We'll be comparing it to a 'dummy' treatment to see if the real stimulation makes a difference.

Key takeaways

Tests a gentle ear stimulation for irregular heartbeats (ventricular arrhythmias).
Aims to reduce frequent irregular beats like PVCs and VT.
The treatment involves wearing a small ear clip daily.
Participation includes trying both active and 'dummy' treatments.
Considered safe with few known side effects from similar uses.
Your regular medical care will continue unaffected.

Who may be eligible?

We are looking for adults aged 18 or over. If you experience many PVCs (more than 10% of your heartbeats in a day), or if you have Ventricular Tachycardia (VT) and already have an implanted device like a defibrillator, you might be able to take part. For those with VT, you should have had at least three significant VT episodes in the last six months.

However, this study might not be suitable for everyone. For example, if you have other serious heart conditions like very serious heart failure, or if you've had a heart attack or heart surgery recently, you might not be able to join. We also cannot include pregnant individuals or people planning to become pregnant in the next year, or anyone who has epilepsy. Also, if you’re currently using a TENS device for another reason, you wouldn’t be eligible.

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 many PVCs (more than 10% of your heartbeats) or VT with an implanted defibrillator?
Are you NOT currently pregnant or planning to be in the next year?
Do you NOT have epilepsy?
Have you NOT had a recent heart attack or major heart surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will not interfere with any ongoing medical treatment you are receiving for your heart condition. We expect your participation to last several weeks. You will be asked to use the LLTS device with an ear clip for about an hour each day. For some of the time, you will receive the actual treatment, and for another period, you will receive a 'sham' or 'dummy' treatment. This 'dummy' treatment looks and feels similar but doesn't deliver the active stimulation. Neither you nor the researchers will know when you are receiving the real versus the dummy treatment until the study is over.

We will monitor your heart rhythm to see how the treatments affect your arrhythmias. If you have PVCs, we will use a Holter monitor (a small, portable device you wear) after each treatment period to count your irregular heartbeats. If you have VT and an implantable defibrillator, the device will continuously record any VT episodes. You will be asked to provide your written consent before participating, ensuring you understand everything involved.

Potential risks and benefits

Participating in this study might offer a potential benefit: if the low-level ear stimulation works, it could help reduce your irregular heartbeats and improve your well-being. However, there's no guarantee it will work for everyone, and it's also possible that you won't experience any direct benefit. The risks associated with this treatment are generally very low, as similar devices have been used safely for many years in other medical conditions. You might feel a mild tingling sensation at the application site, but serious side effects are rare. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

St Bartholomew's Hospital, Barts Health NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is a 'ventricular arrhythmia'?

It's an irregular or fast heartbeat that starts in the lower chambers of your heart.

What is Low-Level Tragus Stimulation (LLTS)?

It's a gentle electrical stimulation applied to a specific part of your ear using a small device and an ear clip, aimed at helping to regulate your heart rhythm.

Is the treatment painful?

No, it's designed to be very gentle. You might feel a mild tingling sensation, but it should not be painful.

Will I know if I'm getting the real treatment or the 'dummy' one?

Neither you nor the study team will know during the study. This helps us get unbiased results.

What is a Holter monitor?

It's a small, portable device you wear that records your heart's electrical activity over 24 hours to detect irregular beats.

How to find out more

Nikhil Ahluwalia, MBBS, PhD

nikhil.ahluwalia@nhs.net +44(0)2037658682 Official trial record

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