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VIBRANT-IBD: Brain Effects of Non-Invasive Vagus Nerve Stimulation in IBD Remission
Sponsor: University of Gdansk
Summary
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.
Official title: VIBRANT-IBD: Pilot fMRI Study on Neural Correlates of Non-Invasive Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease in Remission
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-06-20
Completion Date
2027-05
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Non-invasive vagus nerve stimulation (nVNS)
Participants will undergo non-invasive auricular vagus nerve stimulation (nVNS), also referred to as auricular vagal neuromodulation therapy (AVNT). The intervention is neuromodulatory and autonomic in nature and involves transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus region of the ear. The stimulation will be self-administered by participants at home after standardised training provided by the research team. The intervention period will last 28 consecutive days prior to the second MRI assessment. Participants will perform daily stimulation with a total target duration of 1.5 hours per day. A consistent 45-minute morning session will be required. Another session may be applied reactively during the day or in the evening hours. The total daily stimulation time should remain constant at 1.5 hours. Daily stimulation use, including session timing, duration, and adherence, will be recorded in a participant diary or device log.
Locations (1)
Gastroenterology Department / Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk
Gdansk, Pomeranian Voivodeship, Poland