Not yet recruitingNAINTERVENTIONAL

Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy

If you're an adult living with cerebral palsy (CP) and experience ongoing muscle and joint pain, this study might be for you. We're testing a new, home-based treatment called transcutaneous auricular vagus nerve stimulation (tVNS). This involves placing a small device on your ear to deliver gentle electrical pulses. The aim is to see if this treatment can safely reduce your pain and improve your daily life over 30 days. Some people will get the real treatment, and others a dummy treatment, so we can fairly compare the results. We'll also check for any side effects and how it impacts mood and overall wellbeing.

At a glance

Status

Not yet recruiting

Phase

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

01 Oct 2026

Estimated completion

31 May 2029

Cerebral Palsy (CP)Musculoskeletal Pain

What is this study about?

Many adults with cerebral palsy (CP) regularly experience ongoing muscle and joint pain. This pain can make daily activities harder, affect quality of life, and sometimes lead to feelings of distress. Current treatments don't always completely help, so doctors and researchers are looking for new ways to manage this pain.

This study, taking place over 30 days, is exploring a new approach called transcutaneous auricular vagus nerve stimulation (tVNS). This treatment uses a small device that gently stimulates a specific nerve near the ear. This nerve, called the vagus nerve, plays an important role in how our body handles pain and inflammation. By stimulating it, we hope to reduce pain and inflammation.

We want to find out if this tVNS treatment is safe and effective for adults with CP and long-term muscle and joint pain. Participants will use the device at home, and some will receive the active treatment, while others will receive a 'dummy' (sham) treatment to help us understand the true effects. We'll be looking closely at how much pain is reduced and how it affects daily activities, as well as checking for any side effects. We'll also explore if it helps with things like mood, tiredness, and overall health.

Key takeaways

This study explores a new, gentle electrical stimulation on the ear (tVNS) for pain relief.
It's for adults with cerebral palsy and ongoing muscle and joint pain.
You'll use a small device at home for 30 days.
The study aims to see if tVNS is safe and helps reduce pain and improve daily life.
Some participants will receive active treatment; others a dummy treatment.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, who has been diagnosed with cerebral palsy. You should also have experienced ongoing muscle and joint pain for at least the past year, and this pain should be at a moderate level (meaning it's noticeable, not just a very mild ache).

It's important that any pain or anti-inflammatory medications you're taking have been at a steady dose for at least six weeks before you start the study. Also, you shouldn't have certain health conditions like heart disease, or have medical implants like a pacemaker or a brain shunt. If you are pregnant or planning to become so, or have an infection or open sores on your ear where the device would be placed, you wouldn't 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.

Am I 18 years old or older?
Do I have a diagnosis of cerebral palsy?
Have I had ongoing muscle or joint pain for at least one year?
Is my pain moderate (noticeable) in severity?
Have my pain medications been stable for at least 6 weeks?
Do I have any heart conditions, a pacemaker, or a brain shunt?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to either receive the active tVNS treatment or a 'dummy' (sham) treatment. This part is like drawing names from a hat, and neither you nor the study team will know which one you're getting. You'll use the small electrical stimulation device at home on your ear for 30 days.

Before you start and after the 30 days, you'll have appointments for assessments. These will involve answering questions about your pain, how it affects your daily life, your mood, and your general health. We will also check for any changes in your body, like inflammation levels, and ask about any new symptoms you might experience. The total duration of your active involvement in the study will be just over a month, covering your initial assessments, the 30-day treatment period, and the final checks.

Potential risks and benefits

Potential benefits of taking part could include a reduction in your muscle and joint pain and an improvement in your daily activities and quality of life if the tVNS treatment proves effective. However, it's also possible that the treatment won't help you, or you might receive the 'dummy' treatment, which isn't expected to have a pain-relieving effect. Potential risks are generally low with tVNS and may include skin irritation at the ear where the device is placed, or mild discomfort during stimulation. The study will carefully monitor for any adverse effects. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your usual medical care.

Locations (1)

Parkwood Institute, St Joseph's Health Care London
Verified postcode
London, Canada

Common questions

What exactly is tVNS?

tVNS (transcutaneous auricular vagus nerve stimulation) is a method that uses gentle electrical pulses on your ear to stimulate a nerve called the vagus nerve, which helps regulate pain and inflammation.

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

No, neither you nor the study team will know whether you're receiving the active treatment or a 'dummy' (sham) treatment. This helps us get clearer results.

How long will I need to use the device?

You will use the device at home for 30 days as part of the study intervention.

Are there any side effects?

Known side effects for tVNS are generally mild and might include some skin irritation or discomfort at the application site on your ear. We will monitor you closely for any issues.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

David J Allison, PhD.

david.allison@sjhc.london.on.ca 519 646 6100 Official trial record

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