NCT07636304Enrolling by invitationEarly phase 1
VIBRANT-IBD: Brain Effects of Non-Invasive Vagus Nerve Stimulation in IBD Remission
VIBRANT-IBD: Pilot fMRI Study on Neural Correlates of Non-Invasive Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease in Remission
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The VIBRANT-IBD study is a pilot, prospective, single-arm feasibility study investigating the effects of non-invasive vagus nerve stimulation (nVNS) in adults with inflammatory bowel disease (IBD) in clinical remission. Approximately 15 participants with Crohn's disease or ulcerative colitis will use the Nurosym auricular vagus nerve stimulation device daily for 28 days. Participants will undergo two magnetic resonance imaging (MRI) sessions, one before and one after the intervention. The MRI protocol will include structural imaging, diffusion-weighted imaging, MR angiography, and resting-state functional MRI (rs-fMRI) to assess brain structure and functional connectivity. Before and after the intervention, participants will complete standardised psychological and study-specific questionnaires assessing stress, anxiety, depression, fatigue, emotional functioning, body awareness (interoception), quality of life, gastrointestinal symptom-related experiences, and perceived effects of the intervention. Optional qualitative interviews will additionally explore participants' experiences of living with IBD and using vagus nerve stimulation. The study aims to evaluate the feasibility and preliminary neuropsychological and neurofunctional effects of non-invasive vagus nerve stimulation in individuals with IBD.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 26 May 2026
- Start date
- 7 Aug 2026
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- University of Gdansk
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07636304
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 15
- From 7 Aug 2026 to the primary completion date, 15 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to MRI, including metallic implants, pacemaker, or severe claustrophobia.
- Contraindications to nVNS, including significant cardiac arrhythmias, severe bradycardia, active implanted electronic medical devices, recent trigeminal neuralgia, or previous vagotomy.
Other illness
- Active inflammatory bowel disease flare or clinically significant gastrointestinal symptoms.
- Severe or life-threatening comorbid medical conditions (e.g., active cancer).
- Diagnosed with severe neurological or psychiatric disorders.
Other
- Participants meeting any of the following criteria will be excluded from the study:
- Current pregnancy.
- Ongoing changes in pharmacological treatment that may affect central nervous system functioning.
- Inability to comply with study procedures or complete study assessments.
Who the study is looking for
- Participants must meet all of the following criteria to be eligible for participation:
- Adults aged 18 years or older.
- Diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis.
- Clinical remission of IBD confirmed by medical evaluation.
- Ability to provide informed consent.
- Ability to comply with study procedures and daily use of the stimulation device.
- No contraindications to magnetic resonance imaging (MRI).
- No contraindications to non-invasive vagus nerve stimulation (nVNS).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology Department / Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.