VIBRANT-IBD: Pilot fMRI Study on Neural Correlates of Non-Invasive Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease in Remission
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-invasive vagus nerve stimulation (nVNS) (Device)
结局指标
主要结局
Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation
时间窗: 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
时间窗: 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.
次要结局
- Change in anxiety, depression, and stress levels(Baseline and at least 28 days post-intervention)
- Change in fatigue severity(Baseline and at least 28 days post-intervention)
- Change in quality of life(Baseline and at least 28 days post-intervention)
- Change in interoceptive awareness(Baseline and at least 28 days post-intervention)
- Change in psychological resilience(Baseline and at least 28 days post-intervention)
- Change in emotional functioning and stress-related gastrointestinal experiences(Baseline and at least 28 days post-intervention)
- Intervention adherence and usability(At least 28 days post-intervention)
- Occurrence of adverse events(At least 28 days post-intervention)
- Qualitative assessment of participant experiences(Up to 1 week after Day 28 intervention completion)
研究者
Agata Rudnik
Principal Investigator
University of Gdansk