RecruitingNAINTERVENTIONAL

Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

This research explores a new approach to stimulating the vagus nerve, which helps control many body functions. Currently, when the vagus nerve is stimulated for conditions like epilepsy, it can affect many organs, leading to side effects. This study aims to map out the specific parts of the vagus nerve that connect to different organs like the heart and lungs. Using special tools called nerve cuff electrodes and electrical imaging (EIT), researchers will temporarily study the nerve during operations where vagus nerve stimulators are already being implanted for epilepsy. This will help them learn how to activate only certain parts of the nerve, hoping to treat diseases more effectively with fewer side effects in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

04 Dec 2023

Estimated completion

31 Jul 2027

Vagus Nerve Diseases Epilepsy Vagus Nerve Autonomic Disorder

What is this study about?

This study is part of a new and exciting field called 'electroceuticals,' which focuses on treating various medical conditions by using gentle electrical currents on specific nerves. The vagus nerve is a key target because it's easily accessible during surgery and plays a vital role in controlling many organs throughout your body, including your heart, lungs, and digestive system.

The challenge with current vagus nerve stimulation is that it can affect the whole nerve, leading to unwanted side effects because many organs are stimulated at once. This research aims to understand the vagus nerve in much more detail. Think of the vagus nerve like a collection of many wires, each going to a different organ. Until now, we haven't clearly understood which 'wires' go where in humans. This study wants to create a map of these connections.

To do this, when someone is already having an operation to implant a vagus nerve stimulator for epilepsy, the researchers will use special tools for a short time (about 30 minutes). These tools include a soft cap (nerve cuff) placed around the nerve and a new imaging method called Electrical Impedance Tomography (EIT). This allows them to see in real-time which parts of the nerve are active and how they respond to things like breathing or your heartbeat. The ultimate goal is to find ways to precisely stimulate only the necessary parts of the nerve, which could lead to more effective treatments for epilepsy and other conditions with fewer unwanted effects.

Key takeaways

Researchers are studying the vagus nerve to find better ways to treat diseases.
The goal is to stimulate the nerve more precisely to reduce side effects.
This research happens during a planned surgery for epilepsy patients.
New electrical imaging tools will be used for a short time to map the nerve.
The findings could lead to more effective treatments in the future.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You also need to have a medical condition that either directly involves the vagus nerve or is thought to respond well to vagus nerve stimulation.

It's important that you or a nominated representative can give written consent to take part. This means understanding what the study involves and agreeing to participate.

Unfortunately, if you are under 18 or cannot understand English well enough for explanations, and we are unable to find suitable support to help you understand, you would not be able to join the study.

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 a medical condition that might benefit from vagus nerve stimulation?
Can you understand information about the study in English?
Are you able to provide written consent, or have someone do so for you?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, the research would happen for a brief period (about 30 minutes) during an operation you are already having to implant a vagal nerve stimulator for epilepsy. You wouldn't need any extra visits specifically for this research. During this short time, special nerve cuff electrodes would be placed around your vagus nerve by the surgical team. These tools, along with a new imaging method, would be used temporarily to gather information about your nerve's activity. This is done while you are under anaesthetic, so you would not feel anything during this part of the study. There are no additional medications or long-term follow-up required specifically for this research part of your surgery.

Potential risks and benefits

The potential benefits of this research are not directly for you as an individual, but for future patients. By better understanding the vagus nerve, this study could lead to more targeted and effective treatments for conditions like epilepsy with fewer side effects. As this is done during a planned surgery and with well-established monitoring, the additional risks from the research are expected to be very low. However, as with any medical procedure, there is always a very small possibility of unforeseen issues. You would have the right to withdraw from the research at any point, even during the operation, without affecting your standard medical care.

Locations (1)

National Hospital of Neurology and Neurosurgery
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the vagus nerve?

It's a major nerve running from your brain to many organs, helping control things like your heart rate, breathing, and digestion.

What is 'electroceuticals'?

It's a new way to treat diseases by using small electrical signals to stimulate nerves, rather than just medication.

How is this study different from current treatments?

Current treatments stimulate the whole nerve. This study aims to learn how to stimulate only specific parts, to reduce side effects and make treatments more effective.

Will I feel anything extra during the study?

No, the research will take place while you are under anaesthetic during your planned surgery, so you won't feel anything.

Will this research change my planned surgery for epilepsy?

No, this research is a temporary addition for about 30 minutes during a surgery you are already planning to have. It won't alter the main purpose of your operation.

How to find out more

Kirill Aristovich

k.aristovich@ucl.ac.uk +44 (0) 20 3549 5035 Official trial record

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