NCT03908073

Electrical Vagal Nerve Stimulation in Ulcerative Colitis

Electrical Vagal Nerve Stimulation in Ulcerative Colitis - a Double Blind Placebo - Controlled Study of Transcutaneous Vagal Nerve Stimulation in Ulcerative Colitis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis
• Vagal Nerve Stimulation
• Transcutaneous Vagal Nerve Stimulation

Interventions

Type	Name	Description
DEVICE	Transcutaneous vagal nerve stimulation	The use of a transcutaneous vagal nerve stimulator by the participant

Timeline

• Start date: 2018-10-30
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2019-04-09
• Last updated: 2022-03-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study