EVASION-UC
Research type
Research Study
Full title
Electrical VAgal StimulatION in Ulcerative Colitis – EVASION-UC
IRAS ID
230030
Contact name
Tamara Mogilevski
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 6 days
Research summary
Inflammatory bowel disease (IBD) is common exerting a large personal and societal burden. For individuals, on going symptoms and side effects of treatments combine to reduce quality of life. For society, healthcare costs are considerable and are estimated to be in the order of €5 billion per year across the European Union. Many medications currently used to treat IBD are directed at reducing inflammation within the bowel. However, many of these are associated with significant side effects, can be very expensive and, for some, require admission to hospital for their administration. Therefore the development of new methods and strategies to reduce inflammation in IBD, which are not drug based, are needed.
The autonomic nervous system has two branches known as the sympathetic and parasympathetic nervous systems. The main nerve of the parasympathetic nervous system is the vagus nerve which supplies the majority of the digestive tract including its immune system. Previous studies have shown that lower vagus nerve activity is linked with increased inflammation in the digestive tract. We have recently shown in a pilot study in healthy participants that transcutaneous (applied to the skin) electrical vagal nerve stimulation can increase activity of the vagus nerve and reduce tumour necrosis factor-alpha; a key chemical (cytokine) that causes inflammation in IBD
We aim to assess the effect of transcutaneous electrical vagal nerve stimulation in reducing cytokines causing inflammation in patients with IBD. In patients with ulcerative colitis in remission, we will experimentally induce stress using a protocol that is known to increase cytokines that cause inflammation, such as tumour necrosis factors-alpha; thereby testing the effect of transcutaneous electrical vagal nerve stimulation on its ability to reduce cytokine production in comparison to dummy (placebo) stimulation. The success of this study will be a major advance in non drug treating of ulcerative colitis.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1128
Date of REC Opinion
31 Jul 2018
REC opinion
Further Information Unfavourable Opinion