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

NCT07636304 | Enrolling By Invitation Early Phase 1

• 3 other identifiers: KB 17/262025/09/X/HS6/018402025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Remission of IBD; Crohn's Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Diseases (IBD); In Adults; Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)

Keywords

inflammatory bowel disease; IBD; Crohn's disease; CD; ulcerative colitis; UC; vagus nerve stimulation; transcutaneous vagus nerve stimulation

Outcome Measures

Primary Outcomes (2)

• Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation

  Resting-state functional magnetic resonance imaging will be used to assess changes in functional connectivity between baseline (pre-intervention) and post-intervention measurements following 28 days of daily auricular non-invasive vagus nerve stimulation using the Nurosym device. Analyses will focus on brain networks associated with emotional regulation, interoception, autonomic regulation, and stress processing.

  Baseline and Day 28 (post-intervention)

• Change in structural brain imaging measures following non-invasive vagus nerve stimulation

  Structural magnetic resonance imaging (MRI) assessments, including high-resolution 3D T1-weighted imaging (MPRAGE), diffusion-weighted imaging (DWI), and MR angiography, will be used to explore potential changes in brain morphology, microstructural integrity, and vascular characteristics between baseline and post-intervention measurements.

  Baseline and Day 28 (post-intervention)

Secondary Outcomes (9)

• Change in anxiety, depression, and stress levels

  Baseline and Day 28 (post-intervention)

• Change in fatigue severity

  Baseline and Day 28 (post-intervention)

• Change in quality of life

  Baseline and Day 28 (post-intervention)

• Change in interoceptive awareness

  Baseline and Day 28 (post-intervention)

• Change in psychological resilience

  Baseline and Day 28 (post-intervention)

Study Arms (1)

Adults with IBD in clinical remission receiving non-invasive vagus nerve stimulation

EXPERIMENTAL

This cohort includes adults (≥18 years) diagnosed with inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis, who are in remission at the time of enrollment. Participants will be recruited from gastroenterology outpatient clinics and hospital departments. Participants will undergo a 28-day non-invasive auricular vagus nerve stimulation intervention using the Nurosym device. The intervention consists of daily self-administered stimulation of the auricular branch of the vagus nerve at the tragus region of the ear for approximately 1.5 hours per day following standardised training and instructions. Participants will complete two study visits, before and after the intervention period, including magnetic resonance imaging (MRI) assessments and psychological questionnaires.

Device: Non-invasive vagus nerve stimulation (nVNS)

Interventions

Non-invasive vagus nerve stimulation (nVNS) DEVICE

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.

Adults with IBD in clinical remission receiving non-invasive vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• Active inflammatory bowel disease flare or clinically significant gastrointestinal symptoms.
• Severe or life-threatening comorbid medical conditions (e.g., active cancer).
• 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.
• Current pregnancy.
• Diagnosed with severe neurological or psychiatric disorders.
• Ongoing changes in pharmacological treatment that may affect central nervous system functioning.
• Inability to comply with study procedures or complete study assessments.

Sponsors & Collaborators

• University of Gdansk: lead
• Medical University of Gdansk: collaborator
• Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk: collaborator

Study Sites (1)

Gastroenterology Department / Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk

Gdansk, Pomeranian Voivodeship, 80-104, Poland

Location

Related Publications (16)

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

  PMID: 30513087 BACKGROUND

• Rogowska AM, Tataruch R, Klimowska K. Validation of the shortened 24-item multidimensional assessment of interoceptive awareness, version 2 (Brief MAIA-2). Sci Rep. 2023 Dec 2;13(1):21270. doi: 10.1038/s41598-023-48536-0.

  PMID: 38042880 BACKGROUND

• Makara-Studzinska M, Tyburski E, Zaluski M, Adamczyk K, Mesterhazy J, Mesterhazy A. Confirmatory Factor Analysis of Three Versions of the Depression Anxiety Stress Scale (DASS-42, DASS-21, and DASS-12) in Polish Adults. Front Psychiatry. 2022 Jan 4;12:770532. doi: 10.3389/fpsyt.2021.770532. eCollection 2021.

  PMID: 35058818 BACKGROUND

• Jaracz K, Kalfoss M, Gorna K, Baczyk G. Quality of life in Polish respondents: psychometric properties of the Polish WHOQOL-Bref. Scand J Caring Sci. 2006 Sep;20(3):251-60. doi: 10.1111/j.1471-6712.2006.00401.x.

  PMID: 16922978 BACKGROUND

• Czuber-Dochan W, Norton C, Bassett P, Berliner S, Bredin F, Darvell M, Forbes A, Gay M, Nathan I, Ream E, Terry H. Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale. J Crohns Colitis. 2014 Nov;8(11):1398-406. doi: 10.1016/j.crohns.2014.04.013. Epub 2014 May 22.

  PMID: 24856864 BACKGROUND

• Surzykiewicz J, Konaszewski K, Wagnild G. Polish Version of the Resilience Scale (RS-14): A Validity and Reliability Study in Three Samples. Front Psychol. 2019 Jan 17;9:2762. doi: 10.3389/fpsyg.2018.02762. eCollection 2018.

  PMID: 30705657 BACKGROUND

• Skrobisz K, Piotrowicz G, Naumczyk P, Sabisz A, Markiet K, Rydzewska G, Szurowska E. Imaging of Morphological Background in Selected Functional and Inflammatory Gastrointestinal Diseases in fMRI. Front Psychiatry. 2020 May 20;11:461. doi: 10.3389/fpsyt.2020.00461. eCollection 2020.

  PMID: 32508692 BACKGROUND

• Skrobisz K, Piotrowicz G, Drozdowska A, Markiet K, Sabisz A, Naumczyk P, Rydzewska G, Szurowska E. Use of functional magnetic resonance imaging in patients with irritable bowel syndrome and functional dyspepsia. Prz Gastroenterol. 2019;14(3):163-167. doi: 10.5114/pg.2019.88163. Epub 2019 Sep 27.

  PMID: 31649785 BACKGROUND

• Bonaz B, Bazin T, Pellissier S. The Vagus Nerve at the Interface of the Microbiota-Gut-Brain Axis. Front Neurosci. 2018 Feb 7;12:49. doi: 10.3389/fnins.2018.00049. eCollection 2018.

  PMID: 29467611 BACKGROUND

• Sarb OF, Sarb AD, Leucuta D, Brisc C, Tantau AI. Predictors of Stress, Anxiety, Depression and Quality of Life in Patients Diagnosed with Chronic Inflammatory Bowel Disease in Romania: A Cross-Section Observational Case-Report Study. J Clin Med. 2026 Mar 5;15(5):1996. doi: 10.3390/jcm15051996.

  PMID: 41827416 BACKGROUND

• Ciorba MA, Konnikova L, Hirota SA, Lucchetta EM, Turner JR, Slavin A, Johnson K, Condray CD, Hong S, Cressall BK, Pizarro TT, Hurtado-Lorenzo A, Heller CA, Moss AC, Swantek JL, Garrett WS. Challenges in IBD Research 2024: Preclinical Human IBD Mechanisms. Inflamm Bowel Dis. 2024 May 23;30(Suppl 2):S5-S18. doi: 10.1093/ibd/izae081.

  PMID: 38778627 BACKGROUND

• Radford SJ, McGing J, Czuber-Dochan W, Moran G. Systematic review: the impact of inflammatory bowel disease-related fatigue on health-related quality of life. Frontline Gastroenterol. 2020 Jan 24;12(1):11-21. doi: 10.1136/flgastro-2019-101355. eCollection 2021.

  PMID: 33489066 BACKGROUND

• Liebert A, Wilenska A, Czuber-Dochan W, Klopocka M. Translation and validation of the inflammatory bowel disease fatigue (IBD-F) patient self-assessment questionnaire. Prz Gastroenterol. 2021;16(2):136-143. doi: 10.5114/pg.2021.106665. Epub 2021 Jun 4.

  PMID: 34276841 BACKGROUND

• Radford SJ, Moran GW, Czuber-Dochan W. The impact of Inflammatory Bowel Disease related fatigue on Health-Related Quality of Life: a qualitative semi-structured interview study. J Res Nurs. 2022 Dec;27(8):685-702. doi: 10.1177/17449871211061048. Epub 2022 Jul 5.

  PMID: 36530749 BACKGROUND

• Lommano MG, Farah S, Bianchi B, Risa AM, Sarzi-Puttini P, Salaffi F, Di Carlo M. Non-invasive auricular vagus nerve stimulation in fibromyalgia: Impacts on autonomic function, central sensitization and pain catastrophizing. Joint Bone Spine. 2026 Jan;93(1):105966. doi: 10.1016/j.jbspin.2025.105966. Epub 2025 Sep 9.

  PMID: 40935122 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)