VIBRANT-IBD: Brain Effects of Non-Invasive Vagus Nerve Stimulation in IBD Remission

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.

NCT Number	NCT07636304
Lead Sponsor	University of Gdansk Collaborators: Medical University of Gdansk, Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk
Conditions	Inflammatory Bowel Diseases (IBD), Remission of IBD, In Adults, Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Crohn's Disease (CD), Ulcerative Colitis (UC)
Enrollment	15 participants
Start Date	2026-08-07
Primary Completion	2026-12-15 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-08-11