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Ulcerative ColitisEVASION-UCNCT03908073

Electrical Vagal Nerve Stimulation in Ulcerative Colitis

A study testing Transcutaneous vagal nerve stimulation in people with Ulcerative Colitis and Vagal Nerve Stimulation, run by Queen Mary University of London at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 76 years
What is being tested?
Transcutaneous vagal nerve stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
30 Oct 2018to 15 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females between 18 and 76 years of age (inclusive).
  • Has a clinical diagnosis of UC at least 3 months before screening according to accepted international guidelines.
  • Quiescent disease. Disease activity will be assessed using the validated partial Mayo score and faecal calprotectin of <4 and <250 μg/g (18) respectively, scored within 3 months of entry into the study. Faecal calprotectin <250 μg/g within 2 weeks before study entry to confirm that there has been no change in activity status.
  • Stable medications regimen for 3 months prior to entry into the study, defined as no additions to UC treatment or dosage escalations.
  • Patient is willing and able to participate in the study for the required duration, can understand and is willing to sign the ICF and agrees to undergo all protocol-related tests and procedures.
  • Patient has a BMI between 18 and 35 kg/m2 inclusive.

Who cannot join

  • Has severe extensive colitis and is at imminent risk of colectomy.
  • Presence of a stoma or history of a fistula.
  • Currently taking any topical or oral corticosteroids.
  • Currently taking any anti-TNF therapy, azathioprine, 5-mercaptopurine or methotrexate.
  • Is pregnant, lactating or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use and accepted form of birth control.
  • (Female patients of child-bearing potential must have a negative urine pregnancy test at Screening/pre-dose on Day 1 of the study, excluding female patients of non-child bearing potential who are surgically sterile or post-menopausal. [To be considered post-menopausal female patients must be without menses for 12 consecutive months before screening].)
Show all 19Show fewer
  • Patient has unstable acute illness or exacerbation or an unstable chronic illness or chronic disease (other than UC) that may affect assessments for this study as determined by previous physical examination, medical history, vital signs, ECG, and laboratory (serum biochemistry, haematology, urinalysis) assessments. (Note: Non-fasting elevations of cholesterol and triglycerides are not considered clinically significant.)
  • Patient with medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
  • Has known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF);
  • Has known or suspected cerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery);
  • Has a clinically significant abnormal screening Electrocardiogram (ECG) e.g. second and third degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction);
  • Has had a cervical vagotomy;
  • Has uncontrolled high blood pressure (systolic >160, diastolic >100 after 3 repeated measurements within 24 hours);
  • Is currently implanted with an electrical and/or neurostimulator device (e.g.. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator or occipital nerve stimulator);
  • Has been implanted with metal cervical spine hardware or has a metallic implant near the gammaCore® stimulation site;
  • Has a history of syncope (within last two years);
  • Has a history of seizures (within last five years);
  • Has a known history or suspected history of substance abuse or addiction (within last five years);
  • Has previously used the gammaCore® device.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Tamara Mogilevski

    London, Select One, E1 2AJ

Other trials in United Kingdom

About this study

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

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.

Being tested
Transcutaneous vagal nerve stimulation
Keywords
Ulcerative Colitis, Vagal Nerve Stimulation, Transcutaneous Vagal Nerve Stimulation, Cytokines, LPS stimulated cytokine production
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous vagal nerve stimulationDevice

    The use of a transcutaneous vagal nerve stimulator by the participant

Study groups in NCT03908073
Study groupRoleWhat they receive
Active transcutaneous vagal nerve stimulationActive comparatorThe participant will be taught how to use the device and administer doses in our laboratory and independently at home over a period of 24 hours.
Receives: Device: Transcutaneous vagal nerve stimulation
Sham transcutaneous vagal nerve stimulationPlacebo comparatorThe participant will be taught how to use the device and administer doses in our laboratory and independently at home over a period of 24 hours.
Receives: Device: Transcutaneous vagal nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (3)

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2019
  2. Study start30 Oct 2018
  3. Primary completion15 Mar 2021
  4. Study completion15 Mar 2021

Why it stopped: COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Proof of concept prospective randomized double-blind crossover study evaluating the use of transcutaneous vagal nerve stimulation in a model of acute psychological stress in participants with quiescent Ulcerative colitis
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03908073
Sponsor's protocol ID
18/LO/1693
Acronym
EVASION-UC
Status last verified
Jan 2019
First submitted
22 Feb 2019
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Mogilevski T, Hardy MY, Takahashi K, Smith R, Nguyen AL, Farmer A, Lindsay JO, Tye-Din JA, Aziz Q, Gibson PR. Effects of Stress, Vagal Nerve Stimulation and Disease Activity on Circulating Cytokines, Quantified by an Ultrasensitive Technique, in Ulcerative Colitis: A Pilot Study. JGH Open. 2025 Jun 28;9(7):e70206. doi: 10.1002/jgh3.70206. eCollection 2025 Jul.

    PubMed 40584280

  • Mogilevski T, Nguyen AL, Ajamian M, Smith R, Rosella S, Sparrow MP, Moore GT, Gibson PR. Intestinal barrier biomarkers in clinical evaluation of patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2024 Mar 1;36(3):271-280. doi: 10.1097/MEG.0000000000002681. Epub 2024 Jan 31.

    PubMed 38305113

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous vagal nerve stimulation in people with Ulcerative Colitis and Vagal Nerve Stimulation, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of active transcutaneous vagal nerve stimulation on LPS stimulated TNF-α production in comparison to sham after the stress protocol (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03908073, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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EVASION-UC Clinical Trial NCT03908073 | AzTrials