NCT06090110招募中不适用
Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Clinical meaningful decrease in severity of GI-symptoms
研究概览
简要总结
This randomized control trial aims to evaluate the effect of transcutaneous auricular vagal nerve stimulation in patients with irritable bowel syndrome. The intervention will be 8 weeks of treatment with a vagal nerve stimulator. The main objectives are:
- To evaluate the clinical response, defined as a decrease of at least 50 points on the IBS-SSS questionnaire, of the treatment.
- To ascertain whether the autonomic-vagal neurosignature, derived from pre-treatment registration of symptom profiles, autonomic responses and imaging of neuronal activity as a reaction to stress is able to predict therapeutic response to tVNS accurately.
- To evaluate the effect of treatment on quality of life
- To evaluate the effect of treatment on depression
- To evaluate the effect of treatment on anxiety Participants will be asked to wear a wearable (Fitbit) and fill out a daily questionnaire for one week. Thereafter, a functional brain MRI will be performed.
In the intervention group patients will receive transcutaneous nerve stimulation for 8-weeks at home. The comparison group will receive the same device but with a non-conducting electrode.
Patients fill out weekly questionnaires during the treatment period and at follow-up moments 3 and 6 months after finishing the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of IBS according to Rome IV criteria (3), as follows:
- •Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
- •Related to defecation.
- •Associated with a change in stool frequency.
- •Associated with a change in stool from (appearance).
- •Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- •Age between 18 and 75 years;
- •Ability to understand and speak the Dutch language.
- •Ability to understand how to utilize the ESM application.
排除标准
- •A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present or otherwise based on the principal investigator's judgement.
- •Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device (with the exception of the Mirena IUD), metal braces, facial tattoos and/or metal objects.
- •History of major head trauma or head/brain surgery
- •History of claustrophobia
- •Pregnancy, lactation, intention to become pregnant during the study period
- •Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.
- •If the subject has a cardiac arrhythmia, the attending physician will be consulted before participation.
结局指标
主要结局
Clinical meaningful decrease in severity of GI-symptoms
时间窗: at the end of the 8 week treatment period
Measuring IBS-SSS, defined as a decrease of at least 50 points
次要结局
- Anxiety/depression(at the end of the 8 week treatment period)
- Cost-effectiveness(at follow up moment 2 (6 months after 8 week treatment period))
- adverse events(at the end of the 8 week treatment period)
- Predictive value of neuro-signature(at the end of the 8 week treatment period)
- Time the device was used(at the end of the 8 week treatment period)
研究者
研究点 (2)
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