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Contact Information:

Dr Nicola Baker (Clague-Baker)
+44 7912950671
nicola.baker@liverpool.ac.uk


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Be Part of Research - Trial Details - A trial of stimulating the vagus nerve at the ear for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
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A trial of stimulating the vagus nerve at the ear for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Not Recruiting

Open to: All Genders

Age: Adult

Liverpool

Medical Conditions

Myalgic Encephalomyelitis (ME)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Myalgic Encephalomyelitis (ME), often called Chronic Fatigue Syndrome, is a condition that causes extreme tiredness that doesn’t get better with rest, along with other symptoms like muscle pain, headaches, and problems with concentration. It can significantly impact daily life, but the exact cause is not fully understood. ME affects over 250,000 people in the UK. The main feature is post-exertional malaise (PEM) – a worsening of symptoms after seemingly trivial activity. These symptoms are particularly associated with the autonomic nervous system (ANS). The ANS regulates involuntary physiological processes (such as heart rate and digestion).

Some people with ME (PwME) use Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to manage their symptoms. TaVNS involves stimulating the Vagus nerve which is one of the main parts of the ANS. The stimulation occurs via electrodes applied to the ear. This is the area of skin connected to the vagus nerve. The electrodes produce a gentle tingling/pins and needles sensation which stimulates the nerve and in turn the ANS. To date, there have been only two small studies of taVNS in PwME and neither measured the effect on the ANS.

Aim: To undertake a feasibility trial of taVNS to see if a larger trial to test whether taVNS works for PwME is possible and how to conduct it.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2024 20 Feb 2025

After informed consent, participants will be randomly divided to either receive taVNS or treatment with a sham taVNS device. They will be assessed before and after 3 months treatment. We will mainly test whether a full trial can be conducted by assessing recruitment and drop-out rates; the safety (any side effects of taVNS treatment), what participants think of the treatment and taking part in the trial (via interviews after treatment is complete), and whether the things we measure (outcomes) produce good quality data.


40 PwME will be recruited from ME support groups and online ME forums_

You can take part if:



You may not be able to take part if:


1. Previous or ongoing use of taVNS (as this study is evaluating first-time use of taVNS)2. Inability to stand (as this is part of the assessment procedure)3. Contraindications to Tavns


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Liverpool
    Physiotherapy department
    Liverpool
    L69 3BX

Benefits:
Following two international surveys, the research team recorded the following benefits of taVNS: improvements in: PEM, pain, gut problems, urinary problems and mental health issues. There were also significant improvements in the ability to leave the house. 56% reported beneficial effects of taVNS, with 16% reporting very beneficial effects. 67% said they would recommend it and 4% said they would not recommend it.
For people with ME, taking part will identify if you have abnormal physiological responses to activities and also you will be able to try taVNS for free. We will make every effort to prevent any adverse effects by screening and making sure we monitor your use of taVNS very closely. For everyone with ME, this is important information that we need to identify to help understand the effects of taVNS for people with ME. You will be helping people with ME in the future and help clinicians learn if there is a way to help people with ME. Finally, you will be given £100 for your involvement in the trial
During the assessment you will only be asked to complete activities that you do as part of everyday life. You will not be asked to exercise. We will ensure the appropriate medical cleaning procedures are used for all the equipment you will be using. Due to the lessons learnt from Covid19 we will also ensure that all researchers wear a mask while visiting you as required by the Department of Health and the Chartered Society of Physiotherapy.
Carrying out the 10 min stand test for people with orthostatic intolerance (OI) can cause dizziness and there is a risk of falls. Therefore, this test will be carried out by a qualified physiotherapist who has conducted this test with many people with OI and has been qualified for over 15 years. If you have any difficulties with this test she will stop the test and monitor you until normal values are achieved. Any meaningful results could be shared with your GP with your consent.
Following two international surveys, the research team recorded the following difficulties with taVNS: skin irritation at the site of stimulation (35.3%), headache (14.7%), insomnia (8.6%) and fatigue (8.6%) (Leslie et al., 2024). In terms of aggravating ME symptoms, 7 respondents (6%) reported they felt that using taVNS made them worse. One person reported it caused a crash. If you have any difficulties with taVNS then you can take the device off straight away and contact the researchers.
It is possible when we are discussing the study in the online interviews that you might not want to discuss all aspects of your personal experience and that is fine. If you experience any distress with this discussion we can guide you to support services that might be able to help you. In addition, we can provide a letter to your GP to help you explain your difficulties.

Dr Nicola Baker (Clague-Baker)
+44 7912950671
nicola.baker@liverpool.ac.uk



The study is sponsored by University of Liverpool and funded by University of Liverpool.



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Read full details for Trial ID: ISRCTN15931869
Last updated 14 March 2025

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