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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.
Justin
Durham
justin.durham@newcastle.ac.uk
James
Allison
James.allison@newcastle.ac.uk
Diseases of oral cavity, salivary glands and jawsOther disorders of the nervous system
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Pain is often a big problem for people who have a condition called chronic fatigue syndrome (CFS), which is also known as myalgic encephalomyelitis (ME). This condition causes severe fatigue which makes it difficult to do lots of everyday things. Another group of condition which cause pain in the face and jaws, called temporomandibular disorders (TMD), seem to be more common in people with ME/CFS.
We still don’t fully understand what causes ME/CFS or TMD, but we think that one reason they often occur together could be if both conditions are caused, at least in part, by a similar problem. Problems that affect a part of the nervous system which controls our heart rate, blood pressure, and digestive system among other things (the autonomic nervous system) seem to be more common in people with ME/CFS and TMD.
It is possible that changes in how the brain processes pain, or a problem with the autonomic nervous system could explain why ME/CFS and TMD seem to occur together.
In this research, we hope to understand if the brain responds differently to pain in people with ME/CFS and TMD compared to those without these conditions. We would also like to know if this is affected by differences in the autonomic nervous system.
We will use a method called electroencephalography (EEG) to measure the brain’s electrical activity using small sensors on the scalp. Examining the brain’s response to painful pressure in different body regions (finger and jaw) will help us understand how pain differs in ME/CFS compared to in other people, and where in the brain these differences are located. We will also investigate whether stimulating the vagus nerve (which is part of the autonomic nervous system) makes any difference to the brain's response to pain.
We hope that this study will inform future treatments for ME/CFS by identifying where in the brain differences in response to pain occur, what part the autonomic nervous system plays, and by understanding why some people might differ in their response to treatment.
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:
Observational type: Clinical Laboratory Study;
You can take part if:
You may not be able to take part if:
Participants will be excluded if any of the following apply based on a comprehensive history: • Lack of capacity to understand the study or its questionnaires and therefore the ability to give valid consent. • Under 18 years of age. • Painful dental or orofacial condition or dental treatment in the past three months. • History of trauma to the temporomandibular joint. • TMD of fewer than three months duration (TMD groups). • Arthrogenous TMD as a standalone diagnosis, myogenous TMD with locking or with degenerative joint disease (TMD groups). We will make every reasonable effort to exclude participants with the following conditions, however, these conditions are highly prevalent in patients with TMD and with ME/CFS. As this study is exploratory, it may be necessary to include participants with these conditions if, in the opinion of the investigators, exclusion would affect recruitment in a way that would jeopardise the scientific integrity of the study: • Fibromyalgia • Migraine or other chronic overlapping pain conditions • Sleep or mood disorders (other than ME/CFS) Specific exclusions for the ME/CFS+TMD group relating to the use of nVNS based on medical history will be: • Cardiac arrhythmias, significant cardiovascular disease, or uncontrolled hypertension. Participants with palpitations due to autonomic dysfunction in ME/CFS (including Postural Tachycardia Syndrome) will not be excluded. • Active implantable medical devices including, but not limited to, cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. • Carotid atherosclerosis. • Previous vagotomy. • Metallic implants near the application site. • Pregnancy.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST and funded by ME Research UK .
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for Trial ID: CPMS 53717
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