RecruitingNAINTERVENTIONAL

Aftereffects of PES Preconditioned with RTMS on the Human Pharyngeal Motor Cortex

This study aims to understand how to best activate the brain areas responsible for swallowing. It's an important step because difficulties with swallowing can be a significant health problem for many. The researchers want to see if applying a gentle magnetic pulse to the head, followed by a mild electrical pulse in the throat, can enhance brain activity related to swallowing. Healthy volunteers aged 18 and over are taking part. Each participant will visit the hospital three times, about a week apart. During each visit, they'll have some measurements taken and receive different combinations of real or 'sham' (inactive) magnetic and electrical pulses. The team will then measure their brain's response to see which combination works best. This research could eventually help develop better treatments for people with swallowing difficulties.

At a glance

Status

Recruiting

Phase

Sponsor

University of Manchester

Enrolment target

Start

14 Sep 2024

Estimated completion

31 Aug 2025

Healthy Subjects (HS)

What is this study about?

This study is looking into how we can get our brains to work better when it comes to swallowing. Swallowing might seem simple, but it's actually a very complex process controlled by specific parts of our brain. For many people, especially after illnesses like a stroke, swallowing can become difficult. This can lead to serious health problems, so finding ways to help the brain control swallowing more effectively is really important.

Researchers are using two gentle methods to stimulate the brain: one involves a magnetic pulse applied to the head (rTMS), and the other uses a small electrical pulse in the throat (PES). Individually, these methods have shown promise in affecting brain activity. This study wants to find out if using them one after the other, in a specific order, can make the brain's swallowing areas even more active compared to using just one or none at all.

By understanding the best way to combine these gentle stimulation techniques, scientists hope to lay the groundwork for future treatments. The goal is to eventually help people who struggle with swallowing to do so more easily and safely, improving their quality of life. This current study is a crucial step towards that aim, as it helps us understand the fundamental brain responses in healthy individuals.

Key takeaways

Tests gentle brain and throat stimulation for swallowing.
Aims to improve future treatments for swallowing problems.
Involves 3 visits, each about a week apart.
Participants are healthy adults aged 18 and over.
Compares real and inactive (sham) stimulation methods.
Your safety and comfort are top priorities.

Who may be eligible?

The study is looking for healthy adult volunteers, aged 18 or older. There is no upper age limit, so people of all adult ages can take part as long as they meet the other healthy criteria.

However, some people will not be able to participate. This includes individuals who have ever had epilepsy, a heart pacemaker, or brain surgery. Also, if you have had swallowing problems in the past, or if you have any metal implants in your head, you won't be able to join. Your safety is very important, so the research team needs to make sure it's suitable for you.

Finally, if you are pregnant (or think you might be), or if you are taking any medication that affects your brain or nervous system, you would also not be able to take part in this particular 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?
Are you generally healthy?
Have you ever had epilepsy?
Do you have a heart pacemaker or any metal implants in your head?
Have you ever had brain surgery or problems with swallowing?
Are you pregnant or taking medication that affects your brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will visit the hospital three times in total. Each visit will be scheduled at least one week apart. During each visit, the researchers will take some baseline measurements of your muscle activity in your throat and hand using a gentle electrical method called EMG, which involves a thin tube (catheter) in your throat and sticky pads on your skin.

You will then receive one of three combinations of stimulation: either real magnetic stimulation followed by real electrical stimulation, or one of these being a 'sham' (inactive) treatment. The magnetic stimulation involves a device placed near your head, and the electrical stimulation uses the thin tube in your throat. After the stimulation, the researchers will repeat the muscle activity measurements at several points over the next hour. Each visit will also include a brief survey about how you felt during the procedures. The overall study will involve these three visits, with no long-term follow-up required after your final visit.

Potential risks and benefits

This study aims to discover new information about how brain stimulation can affect swallowing, which could eventually lead to better treatments for people with swallowing difficulties. You might not directly benefit from participating in this study yourself, as it's a very early stage of research. The procedures are generally considered safe, but there's a small chance of mild discomfort during the stimulation or from the throat tube. Any risks will be fully explained before you agree to take part. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

University of Manchester
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is 'sham' stimulation?

Sham stimulation means you'll undergo a procedure that feels similar to the real one, but it's not actually delivering any active stimulation. This helps researchers compare the effects of the real treatment against no treatment.

Will the stimulation hurt?

The magnetic and electrical stimulations are designed to be gentle. You might feel a tapping sensation on your head or a mild sensation in your throat, but it should not be painful. The research team will ensure you are comfortable.

How long will each visit take?

The study summary doesn't specify the exact duration, but each visit will involve baseline measurements, the stimulation procedures, and then follow-up measurements over an hour. You'll also complete a safety survey at the end.

What is a 'pharyngeal catheter'?

It's a thin, flexible tube that will be gently placed into your throat. It has sensors on it to measure muscle activity related to swallowing. It might feel a bit unusual but shouldn't be painful.

Who is funding this research?

The study description doesn't explicitly state the funding source, but it is being conducted by researchers associated with the University of Manchester and Salford Royal Hospital.

How to find out more

Meng Dai, PhD

meng.dai@manchester.ac.uk 44 7585922413 Official trial record

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