Inflammatory Bowel Diseases (IBD)Early Phase 1VIBRANT-IBDNCT07636304

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

A Early Phase 1 study testing Non-invasive vagus nerve stimulation (nVNS) in people with Inflammatory Bowel Diseases (IBD) and Remission of IBD, run by University of Gdansk at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammatory Bowel Diseases (IBD), Remission of IBD, In Adults
What is being tested?: Non-invasive vagus nerve stimulation (nVNS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 sitePoland
Study dates: 7 Aug 2026to May 2027
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site

Gastroenterology Department / Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk
Gdansk, Pomeranian Voivodeship, 80-104

Other trials in Poland

About this study

Official title: VIBRANT-IBD: Pilot fMRI Study on Neural Correlates of Non-Invasive Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease in 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.

Read the detailed description

The VIBRANT-IBD study is a pilot, prospective, single-arm feasibility study designed to investigate the neuropsychological and neurofunctional effects of non-invasive vagus nerve stimulation (nVNS) in adults with inflammatory bowel disease (IBD) who are in clinical remission.

The study focuses on individuals diagnosed with Crohn's disease or ulcerative colitis and aims to explore the relationship between vagal neuromodulation, brain functional connectivity, emotional functioning, stress regulation, fatigue, and quality of life. Approximately 15 adult participants will be recruited from a gastroenterology outpatient clinic and hospital department.

Participants will undergo a 28-day intervention using the Nurosym device, a non-invasive auricular vagus nerve stimulation system. The stimulation will be self-administered daily following standardised instructions after participant training. The intervention involves stimulation of the auricular branch of the vagus nerve at the tragus area of the ear using mild electrical impulses. Stimulation will deliver at a frequency of 25 Hz with a pulse width of 250 µs. Stimulation intensity will be individually adjusted to a comfortable, clearly perceptible, non-painful level following standardized participant training. The total stimulation time will be 1.5 hours per day. The study aims to evaluate preliminary effects of this intervention, the feasibility, and acceptability in individuals with IBD in remission. Each participant will complete two magnetic resonance imaging sessions: one before the intervention and one after the 28-day stimulation period. MRI examinations will be performed using a 3T Magnetom Vida scanner equipped with a 64-channel head coil. The imaging protocol will include structural and functional neuroimaging assessments. Structural MRI will include standard anatomical imaging, high-resolution three-dimensional T1-weighted magnetisation-prepared rapid acquisition gradient echo (3D MPRAGE), diffusion-weighted imaging (DWI), and non-contrast MR angiography using the time-of-flight (TOF) technique. Functional magnetic resonance imaging (rs-fMRI) will be performed during resting-state conditions using T2-weighted Gradient Echo Echo-Planar Imaging (EPI) sequences to assess functional brain connectivity and neural networks.

Participants will also complete a set of standardised psychological questionnaires before and after the intervention. These measures will assess anxiety (DASS-21), depression (DASS-21), stress (DASS-21), fatigue (IBD-F), resilience (RS14), interoceptive awareness (Brief MAIA-2), and quality of life (WHOQoL BREF). In addition, study-specific questionnaires developed for the project will evaluate, e.g., disease-related concerns, fear of relapse, stress-related gastrointestinal symptoms, and daily functioning. Post-intervention assessments will additionally examine treatment adherence, usability, and acceptability of the stimulation device, perceived therapeutic effects, and potential side effects. Optional qualitative interviews will also be conducted with interested participants to explore personal experiences related to living with IBD and using vagus nerve stimulation therapy.

The primary objective of the study is to explore changes in brain functional connectivity following non-invasive vagus nerve stimulation in adults with IBD in remission. Secondary objectives are to evaluate the feasibility and safety of the intervention and to assess psychological outcomes, including associations between neuroimaging findings and psychological measures.

The study may contribute to a better understanding of brain-gut interactions and the potential role of neuromodulation as a supportive non-pharmacological intervention in IBD.

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)
Being tested: Non-invasive vagus nerve stimulation (nVNS)
Keywords: inflammatory bowel disease, IBD, Crohn's disease, CD, ulcerative colitis, UC, vagus nerve stimulation, transcutaneous vagus nerve stimulation
Medical subject headings: Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

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

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.

Study groups in NCT07636304
Study group	Role	What they receive
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. Receives: Device: Non-invasive vagus nerve stimulation (nVNS)

What is being measured

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

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.
Measured: Baseline and at least 28 days 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.
Measured: Baseline and at least 28 days post-intervention

Secondary outcomes (9)

Change in anxiety, depression, and stress levels
Changes in psychological distress will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21). The DASS-21 is a 21-item self-report questionnaire measuring symptoms of depression, anxiety, and stress over the past week. It includes three 7-item subscales. Each item is rated from 0 to 3, and subscale scores are summed for each subscale, yielding raw subscale scores ranging from 0 to 21. Scores may also be multiplied by 2 to obtain scores comparable with the full 42-item DASS, resulting in subscale scores ranging from 0 to 42. Higher Depression, Anxiety, or Stress scores indicate greater symptom severity in the respective domain.
Measured: Baseline and at least 28 days post-intervention
Change in fatigue severity
Fatigue-related symptoms and their impact on functioning will be assessed using the Inflammatory Bowel Disease Fatigue Scale (IBD-F). The IBD-F Scale includes a section on fatigue severity, frequency, and duration, and a section on the impact of fatigue on daily functioning. Items are scored from 0 to 4, with higher scores indicating greater fatigue or a greater impact of fatigue on everyday life. The fatigue severity, frequency, and duration section has a maximum score of 20, while the impact of fatigue on daily functioning section has a maximum score of 120. Higher scores reflect more severe fatigue-related symptoms and greater functional impact.
Measured: Baseline and at least 28 days post-intervention
Change in quality of life
Quality of life will be evaluated using the Polish version of the World Health Organization Quality of Life questionnaire, WHOQOL-BREF. The WHOQOL-BREF is a short, generic self-report questionnaire. The tool contains 26 items: 24 items grouped into four domains - physical health, psychological health, social relationships, and environment - plus two general items assessing overall quality of life and satisfaction with health. Items are rated from 1 to 5, with higher scores generally indicating better quality of life. Raw domain scores are calculated by summing the items within each domain: physical health has a maximum raw score of 35, psychological health has a maximum raw score of 30, social relationships has a maximum raw score of 15, and environment has a maximum raw score of 40. The two general items are scored separately, each with a maximum score of 5. Domain scores may also be transformed to a 4-20 or 0-100 scale, with higher scores indicating better quality of life.
Measured: Baseline and at least 28 days post-intervention
Change in interoceptive awareness
The Brief Multidimensional Assessment of Interoceptive Awareness, version 2 (Brief MAIA-2), is a 24-item self-report questionnaire used to assess interoceptive awareness, meaning how a person perceives, attends to, interprets, and trusts internal bodily sensations. The tool includes eight 3-item subscales: Noticing, Not Distracting, Not Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Items are rated from 0 (never) to 5 (always). Subscale scores are typically calculated as the mean of the three items in each subscale and therefore range from 0 to 5. If item scores are summed within each subscale, each 3-item subscale has a maximum score of 15, and the total maximum score across all 24 items is 120. Higher scores indicate greater interoceptive awareness or a stronger ability to perceive and use bodily sensations.
Measured: Baseline and at least 28 days post-intervention
Change in psychological resilience
Psychological resilience will be measured using the Resilience Scale (RS-14). The scale consists of 14 items, each rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 14 to 98, with higher scores indicating higher resilience.
Measured: Baseline and at least 28 days post-intervention
Change in emotional functioning and stress-related gastrointestinal experiences
The self-constructed study-specific questionnaire will assess fear of disease relapse, emotional tension, stress-related gastrointestinal symptoms, body awareness, perceived control over health, psychosocial functioning, and expectations toward non-invasive vagus nerve stimulation. It will also assess participants' general health status on a 1-10 scale, where 1 indicates very poor health and 10 indicates very good health. Items are mainly rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating stronger agreement with each statement. As a study-specific tool, it should be treated as an exploratory questionnaire rather than a standardised validated scale.
Measured: Baseline and at least 28 days post-intervention
Intervention adherence and usability
Participant adherence, usability, comfort, and acceptability of the intervention will be assessed using a study-specific post-intervention questionnaire. The questionnaire includes items on the frequency of stimulation, ease of device use, technical difficulties, perceived comfort, safety, willingness to continue therapy, and whether the participant would recommend it to others with IBD. It will also assess participants' general health status on a 1-10 scale, where 1 indicates very poor health and 10 indicates very good health. Most items are rated on a 5-point scale, with higher scores indicating more positive evaluation of the intervention. The questionnaire also records perceived changes in well-being, IBD-related functioning, stress response, adverse effects, and open-ended feedback about the therapy experience. As a study-specific tool, it should be treated as an exploratory questionnaire rather than a standardised validated scale.
Measured: At least 28 days post-intervention
Occurrence of adverse events
Occurrence of adverse events will be measured using the study-specific post-intervention questionnaire. Participants will be asked whether any adverse events occurred during therapy, with multiple-choice response options including: no adverse events, discomfort at the stimulation site, headache, dizziness, fatigue, sleepiness, worsening of gastrointestinal symptoms, anxiety, and other symptoms specified by the participant. Additional comments can be provided in an open-text field. As a study-specific tool, it should be treated as an exploratory questionnaire rather than a standardised validated scale.
Measured: At least 28 days post-intervention
Qualitative assessment of participant experiences
Optional semi-structured qualitative interviews will explore participant experiences related to living with IBD and using vagus nerve stimulation therapy. Interviews will be conducted up to one week after completion of the intervention, depending on participant availability.
Measured: Up to 1 week after Day 28 intervention completion

Timeline

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

7 Aug 2026May 2027

First posted9 Jun 2026
Study start7 Aug 2026 (estimated)
Primary completion15 Dec 2026 (estimated)
Study completionMay 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Inflammatory Bowel Diseases (IBD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07636304
Sponsor's protocol ID: KB 17/26
Other IDs: 2025/09/X/HS6/01840, 2025
Acronym: VIBRANT-IBD
Status last verified: Aug 2026
First submitted: 26 May 2026
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared due to the risk of participant re-identification and to protect confidentiality.

Publications

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.
PubMed 7726811
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.
PubMed 30513087
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.
PubMed 38042880
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.
PubMed 35058818
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.
PubMed 16922978
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.
PubMed 24856864
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.
PubMed 30705657
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.
PubMed 32508692
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.
PubMed 31649785
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.
PubMed 29467611
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.
PubMed 41827416
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.
PubMed 38778627
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.
PubMed 33489066
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.
PubMed 34276841
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.
PubMed 36530749

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VIBRANT-IBD: Pilot fMRI Study on Neural Correlates of Non-Invasive Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease in Remission
ClinicalTrials.gov ID: NCT07636304
Acronym / sponsor ID: VIBRANT-IBD / KB 17/26
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)
Keywords: inflammatory bowel disease, IBD, Crohn's disease, CD, ulcerative colitis, UC, vagus nerve stimulation, transcutaneous vagus nerve stimulation
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 15 participants (estimated)
Lead sponsor: University of GdanskUniversity, hospital or other
Collaborators: Medical University of Gdansk, Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk
Study start: 7 Aug 2026 (estimated)
Primary completion: 15 Dec 2026 (estimated)
Study completion: May 2027 (estimated)
First posted: 9 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Approximately 15 participants with Crohn's disease or ulcerative colitis will use the Nurosym auricular vagus nerve stimulation device daily for 28 days.

The study aims to evaluate the feasibility and preliminary neuropsychological and neurofunctional effects of non-invasive vagus nerve stimulation in individuals with IBD.

Detailed description

The study may contribute to a better understanding of brain-gut interactions and the potential role of neuromodulation as a supportive non-pharmacological intervention in IBD.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adults with IBD in clinical remission receiving non-invasive vagus nerve stimulation	Experimental	Device: Non-invasive vagus nerve stimulation (nVNS)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Adults with IBD in clinical remission receiving non-invasive vagus nerve stimulation

Primary outcome

Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation
Time frame: Baseline and at least 28 days post-intervention
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.
Change in structural brain imaging measures following non-invasive vagus nerve stimulation
Time frame: Baseline and at least 28 days post-intervention
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.

9 secondary outcomes

Change in anxiety, depression, and stress levels
Time frame: Baseline and at least 28 days post-intervention
Change in fatigue severity
Time frame: Baseline and at least 28 days post-intervention
Change in quality of life
Time frame: Baseline and at least 28 days post-intervention
Change in interoceptive awareness
Time frame: Baseline and at least 28 days post-intervention
Change in psychological resilience
Time frame: Baseline and at least 28 days post-intervention
Change in emotional functioning and stress-related gastrointestinal experiences
Time frame: Baseline and at least 28 days post-intervention
Intervention adherence and usability
Time frame: At least 28 days post-intervention
Occurrence of adverse events
Time frame: At least 28 days post-intervention
Qualitative assessment of participant experiences
Time frame: Up to 1 week after Day 28 intervention completion

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Background: PubMed 7726811Lovibond 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.
Background: PubMed 30513087Mehling 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.
Background: PubMed 38042880Rogowska 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.
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Individual participant dataSharing planned: No. IPD will not be shared due to the risk of participant re-identification and to protect confidentiality.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Non-invasive vagus nerve stimulation (nVNS) in people with Inflammatory Bowel Diseases (IBD) and Remission of IBD, run by University of Gdansk at 1 site in Poland.

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 8 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. 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 Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation (time frame: Baseline and at least 28 days post-intervention). The study lists 2 primary outcomes in all. 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 NCT07636304, which also lists 16 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 11 Aug 2026.