Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Maria Germann
+44 (0) 191 208 6977
maria.germann@newcastle.ac.uk


Dr Mark Baker
+44 (0)191 208 6897
mark.baker@newcastle.ac.uk


Ms Maria Germann
+44 (0) 191 208 6977
maria.germann@newcastle.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Pausing post-COVID fatigue

Pausing post-COVID fatigue

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Post-COVID fatigue


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.


Fatigue is a very common symptom of Long COVID. Feedback from those with post-COVID fatigue (pCF) has highlighted the devastating impact it has on their lives and the need for novel therapeutic options.
As with all forms of post-viral fatigue, the causes of pCF are likely to be multi-factorial. However, as a post-infectious phenomenon, inflammatory/immune processes are likely to be important. Fatigue encompasses not only the perception of increased physical effort and extreme tiredness but also cognitive/mental fatigue (problems with thinking, remembering and concentrating). As part of a separate study, we have recently shown that such symptoms in pCF are associated with measurable changes in the nervous system.
There is increasing evidence that COVID-19 can affect the autonomic nervous system. Interestingly, most of the changes could be mediated by the vagus nerve. If true, stimulation of the vagus nerve might help to prove that the changes we have observed have a mechanistic role in pCF.
The vagus nerve controls many of the unconscious functions of the body. However, it also provides access for modulating abnormal brain networks and neuroinflammatory pathways by electrical nerve stimulation. For example, the surgical implantation of devices for stimulating the vagus nerve is a long-established approach for managing difficult to treat epilepsy. Non-invasive vagus nerve stimulation (nVNS), delivered through electrodes placed on the skin of the neck, avoids the risks of surgery, and is now also recognized to be an effective treatment for certain headache disorders. More recently, small studies in patients who have chronic immune-mediated diseases associated with fatigue have shown that nVNS significantly reduces the symptoms of fatigue. If nVNS can improve symptoms of fatigue in chronic immune-mediated diseases it should in theory also be effective in pCF.
Whilst most studies have stimulated the vagus nerve non-invasively via electrodes placed on the neck, the vagus can also be activated by stimulating the skin of the ear. Transcutaneous auricular vagus nerve stimulation (taVNS) is potentially an easier and more reliable approach to activating the vagus nerve and can be self-administered safely at home. Moreover, taVNS can be delivered with a handheld battery-powered transcutaneous electrical nerve stimulation (TENS) device purchased without prescription over the counter, or online.
This study will:
1. Probe the mechanisms of pCF in adults by testing whether taVNS self-administered using a TENS device can reduce symptoms of fatigue (assessed by questionnaires) and normalise changes in the peripheral and central nervous system that are hypothesized to mediate fatigue; and
2. Provide trial evidence as to whether taVNS is an effective intervention for pCF.

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:

15 May 2022 30 Apr 2024

Fatigue and biometric/neurophysiological/behavioural assessments are completed and blood samples collected (week 1). Participants will be fitted with wearable technology and smartphones for collecting data will be provided, and baseline ambulatory data collected for 7 days. During this 7-day period, participants will be randomly allocated to one of the three experimental groups – active tragus stimulation, sham tragus stimulation (control 1) and active pinna/greater auricular nerve stimulation (control 2). At the Week 2 visit fatigue assessments will be repeated, taVNS parameters will be set and equipment, consumables and instructions for the assigned intervention provided in a box. In weeks 3-4 wearable devices (patches and smartphones) will be collected and the fatigue assessments repeated. At the Week 8 visit neurophysiology, behavioural and fatigue assessments will be repeated, and participants receiving active VNS will continue for a further 8 weeks and those initially in the control arms will cross over to the active intervention for the last 8 weeks of their participation in the study; thus all participants will have the opportunity to experience the active VNS intervention. At Week 12 fatigue assessments will again be completed and at the Week 16 visit, all assessments will be repeated.


Members of the public who have a verifiable positive COVID-19 diagnosis but who did not require hospitalisation and who are at least 2 weeks after diagnosis. They will be screened for symptoms of fatigue.

You can take part if:



You may not be able to take part if:


1. Previous diagnosis of neurological or psychiatric disorder2. Cardiac disease (e.g., cardiomyopathy, myocardial infarction, arrhythmia, prolonged QT interval, etc)3. Implanted device (e.g., pacemaker)4. Pregnant5. Not fluent in English


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

  • Newcastle University
    Henry Wellcome Building The Medical School Framlington Place
    Newcastle upon Tyne
    NE2 4HH

Members of the public with post-COVID fatigue may benefit from an improvement in fatigue syndromes. Participants will help with basic research. There are no associated risks in participating.

Ms Maria Germann
+44 (0) 191 208 6977
maria.germann@newcastle.ac.uk


Ms Maria Germann
+44 (0) 191 208 6977
maria.germann@newcastle.ac.uk


Dr Mark Baker
+44 (0)191 208 6897
mark.baker@newcastle.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Newcastle University and funded by National Institute for Health Research.




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Read full details for Trial ID: ISRCTN18015802
Last updated 11 March 2024

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