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NCT03908073: EVASION-UC

Electrical Vagal Nerve Stimulation in Ulcerative Colitis

Terminated NA Last updated 22 March 2022
What this trial tests

NA trial testing Transcutaneous vagal nerve stimulation in Ulcerative Colitis in 12 participants. Terminated before completion.

Timeline
30 October 2018
Primary endpoint
15 March 2021
15 March 2021

Quick facts

Lead sponsorQueen Mary University of London
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposeother
Enrollment12
Start date30 October 2018
Primary completion15 March 2021
Estimated completion15 March 2021
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Queen Mary University of London

Who can join

Adults 18 to 76, any sex, with Ulcerative Colitis or Vagal Nerve Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapeutic Potential of Vagus Nerve Stimulation for Inflammatory Bowel Diseases.
    Bonaz B, Sinniger V, Pellissier S. · · 2021 · cited 108× · PMID 33828455 · DOI 10.3389/fnins.2021.650971
  2. Anatomical and clinical implications of vagal modulation of the spleen.
    Bassi GS, Kanashiro A, Coimbra NC, Terrando N, et al · · 2020 · cited 59× · PMID 32061636 · DOI 10.1016/j.neubiorev.2020.02.011
  3. Neuro-Immune Circuits Regulate Immune Responses in Tissues and Organ Homeostasis.
    Jakob MO, Murugan S, Klose CSN. · · 2020 · cited 54× · PMID 32265899 · DOI 10.3389/fimmu.2020.00308
  4. Cholinergic immunomodulation in inflammatory bowel diseases.
    Serafini MA, Paz AH, Nunes NS. · · 2022 · cited 16× · PMID 34977822 · DOI 10.1016/j.bbih.2021.100401
  5. Effects of Stress, Vagal Nerve Stimulation and Disease Activity on Circulating Cytokines, Quantified by an Ultrasensitive Technique, in Ulcerative Colitis: A Pilot Study.
    Mogilevski T, Hardy MY, Takahashi K, Smith R, et al · · 2025 · cited 1× · PMID 40584280 · DOI 10.1002/jgh3.70206
  6. Macrophages as central mediators of sympathetic neuro-immune interplay in autoimmunity.
    Muntjewerff EM, Josyula VS, Lehmair F, Christoffersson G. · · 2025 · PMID 41476959 · DOI 10.3389/fimmu.2025.1654382

Verify or expand the search:

Other trials of Transcutaneous vagal nerve stimulation

Trials testing the same drug.

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

Other Queen Mary University of London trials

Trials by the same sponsor.

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