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

3 giugno 2026 aggiornato da: Agata Rudnik, University of Gdansk

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

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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. The total stimulation time will be approximately 1.5 hours per day. The study aims to evaluate the feasibility, acceptability, and preliminary effects of this intervention 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 evaluate the feasibility and safety of non-invasive vagus nerve stimulation in adults with IBD in remission. Secondary objectives include exploring preliminary changes in brain functional connectivity and investigating associations between neuroimaging findings and psychological outcomes following the intervention.

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

15

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria

Participants must meet all of the following criteria to be eligible for participation:

  1. Adults aged 18 years or older.
  2. Diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis.
  3. Clinical remission of IBD confirmed by medical evaluation.
  4. Ability to provide informed consent.
  5. Ability to comply with study procedures and daily use of the stimulation device.
  6. No contraindications to magnetic resonance imaging (MRI).
  7. No contraindications to non-invasive vagus nerve stimulation (nVNS).

Exclusion Criteria

Participants meeting any of the following criteria will be excluded from the study:

  1. Active inflammatory bowel disease flare or clinically significant gastrointestinal symptoms.
  2. Severe or life-threatening comorbid medical conditions (e.g., active cancer).
  3. Contraindications to MRI, including metallic implants, pacemaker, or severe claustrophobia.
  4. Contraindications to nVNS, including significant cardiac arrhythmias, severe bradycardia, active implanted electronic medical devices, recent trigeminal neuralgia, or previous vagotomy.
  5. Current pregnancy.
  6. Diagnosed with severe neurological or psychiatric disorders.
  7. Ongoing changes in pharmacological treatment that may affect central nervous system functioning.
  8. Inability to comply with study procedures or complete study assessments.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Adults with IBD in clinical remission receiving non-invasive vagus nerve stimulation

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.
Dispositivo: 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 approximately 1.5 hours per day. A consistent morning session (e.g., approximately 45 minutes) will be recommended, with the possibility of additional reactive sessions during the day if needed. The total daily stimulation time should remain constant at approximately 1.5 hours, and any missing stimulation time may be completed during evening hours on the same day.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation
Lasso di tempo: Baseline and Day 28 (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.
Baseline and Day 28 (post-intervention)
Change in structural brain imaging measures following non-invasive vagus nerve stimulation
Lasso di tempo: Baseline and Day 28 (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.
Baseline and Day 28 (post-intervention)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in anxiety, depression, and stress levels
Lasso di tempo: Baseline and Day 28 (post-intervention)
Changes in psychological distress will be assessed using the Depression Anxiety Stress Scales (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; higher scores indicate greater symptom severity. In clinical trial registration, it can be described as an outcome measure where higher Depression, Anxiety, or Stress scores reflect more severe symptoms in the respective domain. The original DASS was developed by P.F. Lovibond and S.H. Lovibond (1995), and the Polish adaptation was prepared and published by M. Makara-Studzińska, M. Załuski, K. Adamczyk and E. Tyburski (2022).
Baseline and Day 28 (post-intervention)
Change in fatigue severity
Lasso di tempo: Baseline and Day 28 (post-intervention)
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 greater impact of fatigue on everyday life. The original English version was developed by W. Czuber-Dochan et al. (2014), and the Polish version was translated and validated by A. Liebert, A. Wileńska, W. Czuber-Dochan, and M. Kłopocka (2021).
Baseline and Day 28 (post-intervention)
Change in quality of life
Lasso di tempo: Baseline and Day 28 (post-intervention)
Quality of life will be evaluated using the WHOQOL-BREF questionnaire. The WHOQOL-BREF is a short, generic self-report questionnaire developed by the World Health Organization Quality of Life Group to assess quality of life across cultures (the Polish WHOQOL-BREF was introduced in 1999). 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.
Baseline and Day 28 (post-intervention)
Change in interoceptive awareness
Lasso di tempo: Baseline and Day 28 (post-intervention)
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). Higher scores indicate greater interoceptive awareness or stronger ability to perceive and use bodily sensations. The original MAIA was developed by Mehling et al. (2018), and the Polish version of Brief MAIA-2 was validated by A. M. Rogowska, R. Tataruch, and K. Klimowska (2023).
Baseline and Day 28 (post-intervention)
Change in psychological resilience
Lasso di tempo: Baseline and Day 28 (post-intervention)
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. The short RS-14 version was developed by G. Wagnild (2009), the Polish version was validated by J. Surzykiewicz, K. Konaszewski, and G. Wagnild (2019).
Baseline and Day 28 (post-intervention)
Change in emotional functioning and stress-related gastrointestinal experiences
Lasso di tempo: Baseline and Day 28 (post-intervention)
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.
Baseline and Day 28 (post-intervention)
Intervention adherence and usability
Lasso di tempo: Day 28 (post-intervention)
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.
Day 28 (post-intervention)
Occurrence of adverse events
Lasso di tempo: Day 28 (post-intervention)
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.
Day 28 (post-intervention)
Qualitative assessment of participant experiences
Lasso di tempo: Up to 1 week after Day 28 intervention completion
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.
Up to 1 week after Day 28 intervention completion

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Gdansk

Collaboratori

Medical University of Gdansk
Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

15 dicembre 2026

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KB 17/26
  • 2025 (Altro identificatore: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025/09/X/HS6/01840 (Altro numero di sovvenzione/finanziamento: Polish National Science Centre (NCN))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD will not be shared due to the risk of participant re-identification and to protect confidentiality.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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