RecruitingNAINTERVENTIONAL

Non-invasive Ultrasonic Auricular Vagus Nerve Stimulation

This research is exploring a new, gentler technique called Ultrasound Vagus Nerve Stimulation (U-VNS) using a device called ZenBud. The Vagus nerve is a really important nerve that helps control things like breathing, heart rate, and digestion, and plays a big role in how we relax. Instead of using electrical pulses, which can be tricky to aim, this new method uses sound waves to stimulate the nerve in the ear. Researchers want to understand how U-VNS affects healthy people's physical and mental responses before testing it on those with specific health issues. The goal is to see if this targeted approach could eventually help manage conditions like anxiety or depression more effectively.

At a glance

Status

Recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

Start

01 Oct 2025

Estimated completion

01 May 2026

Healthy Participants

What is this study about?

Imagine your body has a superhighway connecting your brain to many of your organs, controlling things you don't even think about, like your breathing, heart rate, and digestion. That's a bit like your Vagus nerve! It's also super important for helping your body relax. Sometimes, giving this nerve a little nudge, or 'stimulation,' can help with certain health problems.

Traditionally, stimulating the Vagus nerve has either involved a small operation to place a device inside the body, or using a device on the skin that sends tiny electrical pulses. However, these electrical pulses can sometimes be hard to direct precisely to the nerve because electricity doesn't always go where you want it to, especially through skin or bone. This study is testing a brand-new way to stimulate this important nerve using sound waves, which are much easier to guide precisely.

The new device, called ZenBud, uses these sound waves to gently stimulate a specific part of the Vagus nerve located in your ear. Because sound waves can be aimed more accurately than electrical pulses, this method might be better at reaching the Vagus nerve directly. For now, researchers want to see how this gentle sound wave stimulation affects healthy people, looking at any changes in their body, thoughts, or feelings. Understanding these effects in healthy individuals is a crucial first step before thinking about how it might help people with conditions like anxiety or depression in the future.

Key takeaways

A new ultrasound device (ZenBud) is being tested for Vagus nerve stimulation.
This method uses sound waves for more precise targeting than electricity.
The study involves healthy volunteers, not people with existing conditions.
The aim is to understand the device's effects on the body and mind.
This research could pave the way for future treatments for anxiety or mood issues.
Your participation is crucial for advancing medical understanding.

Who may be eligible?

This study is looking for healthy adults aged 18 or older. You generally need to be in good health and not currently taking many medications (birth control pills are usually fine). You also need to be willing to follow some simple instructions, like removing ear piercings for the study and avoiding certain things like heavy exercise or food for a short time before some visits.

There are several reasons why you might not be able to join. For example, if you have ever had a major brain, nerve, or mental health condition (including self-reported depression), or certain heart problems, diabetes, or high blood pressure, you wouldn't be eligible. Also, if you're pregnant, breastfeeding, or have allergies to certain gels, you can't take part. It's also important that you haven't been in another research study involving procedures or payments in the last three months, and you shouldn't be taking medications that affect your nervous system or consume excessive alcohol or tobacco.

Quick self-check

Are you 18 years old or older?
Are you in generally good health and not currently on many medications (birth control is usually okay)?
Have you *never* had a major brain, nerve, or mental health issue like depression, or serious heart problems?
Are you able to avoid food and exercise for 12 hours before some study visits?
Are you not pregnant or breastfeeding, and don't have allergies to common gels?
Are you willing to remove any piercings in your left ear for the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll visit the study centre multiple times. Each time, researchers will use the ZenBud device on your ear to stimulate your Vagus nerve with ultrasound. They'll be checking how your body and mind respond to this stimulation. You'll need to remove any left ear piercings. Before two of the visits, you'll need to avoid exercise and food for 12 hours. The study will involve several assessments to understand the effects of the stimulation. The total duration of your involvement will depend on the study schedule, which the research team will explain in detail.

Potential risks and benefits

Taking part in this study won't directly improve your health, as it's designed for healthy people to understand how the device works. However, your involvement is very important as it helps scientists learn more about this new technology, which could eventually lead to new treatments for others. As with any study, there could be minor risks, like temporary discomfort from the device or the requirements for fasting. For example, if you have ever had a major brain, nerve, or mental health condition or specific heart issues, you would not be eligible to participate. You are free to withdraw from the study at any time without giving a reason, and it won't affect any future medical care you might receive.

Locations (2)

Neuromodulation Lab, Medical School, Queen's Medical Centre
Nottingham, United Kingdom· Recruiting
University of Nottingham
Nottingham, United Kingdom· Not yet recruiting

Common questions

What is the Vagus nerve?

It's a main nerve connecting your brain to many organs, helping control things like breathing, heart rate, and digestion, and plays a big role in relaxation.

What is new about this study?

It's testing a new device called ZenBud that uses gentle sound waves, instead of electricity, to stimulate the Vagus nerve more precisely.

Will this study help my health?

This study is for healthy people to understand the device better; it won't directly treat any conditions you may have, but it helps future research.

Are there any side effects?

As it's a new method, we don't expect major side effects, but any potential minor discomfort will be explained by the study team.

How long will my involvement last?

The study involves multiple visits, and the research team will provide you with a detailed schedule for your participation.

How to find out more

Alicia Falcon-Caro, PhD

Alicia.falconcaro@nottingham.ac.uk +44 7502043643 Official trial record

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