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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.
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.
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:
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.
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.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.