There are approximately 2.5-3 million patients with inflammatory bowel disease (IBD) across Europe, with associated healthcare costs of €4.6-5.6 billion per annum (1). IBD is associated with a significant reduction in quality of life. Treatments directed towards modifying the inflammatory response, such as anti-tumour necrosis factor-alpha (TNF-α) agents, are expensive, can necessitate admission to hospital for their administration and can be associated with side effects (2 3). Thus, the development of a novel non-pharmacological anti-inflammatory intervention, such as electrical vagal nerve stimulation, is warranted. This is a proof of concept study which aims to investigate whether transcutaneous vagal nerve stimulation is effective at reducing stress induced inflammatory cytokine levels in patients with quiescent ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
12
The use of a transcutaneous vagal nerve stimulator by the participant
Tamara Mogilevski
London, Select One, United Kingdom
The effect of active transcutaneous vagal nerve stimulation on LPS stimulated TNF-α production in comparison to sham after the stress protocol
Whole blood taken from the participants is stimulated with LPS. The concentration of TNF-α will be measured using the ELISA technique. TNF-α level of intervention versus sham is the primary outcome measure.
Time frame: 1 year
The effect of active transcutaneous vagal nerve stimulation compared to sham on LPS stimulated TNF-α production without the stress protocol
Whole blood taken from the participants is stimulated with LPS. The concentration of TNF-α will be measured using the ELISA technique. TNF-α level of intervention versus sham without the stress protocol is a secondary measure.
Time frame: 1 year
Cardiac vagal tone at baseline visits 1 and 2 and post stress protocol
Cadriac vagal tone and autonomic nervous system monitoring is performed in our laboratory using a specialised device called 'powerlab'. It is able to convert ECG data into autonomic parameters, including vagal tone, which the investigators can then use as an outcome measure.
Time frame: 1 year
The effect of active transcutaneous vagal nerve stimulation compared to sham on LPS stimulated Il6 and Il10 production with and without the stress protocol
Whole blood taken from the participants is stimulated with LPS. The concentration of IL6 and IL10 will be measured using the ELISA technique. IL6 and IL10 level of intervention versus sham without the stress protocol is a secondary measure.
Time frame: 1 year
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