Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
2026年6月17日 更新者：Zain Sobani、West Virginia University
Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype
This study evaluates the efficacy and safety of transcutaneous auricular vagus nerve stimulation (ta-VNS) in adults with constipation-predominant irritable bowel syndrome (IBS-C). Participants will be randomized to receive either active or sham stimulation using a non-invasive auricular device over a 60-day period.
The primary objectives are to assess changes in symptom severity and quality of life using validated instruments, including the IBS Symptom Severity Scale (IBS-SSS) and the IBS Quality of Life questionnaire (IBS-QOL). Secondary assessments include safety and participant compliance.
This study aims to determine whether ta-VNS is an effective non-invasive therapeutic modality for improving symptoms and quality of life in patients with IBS-C.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zain Sobani, MD
- 电话号码：304-598-6200
- 邮箱：zain.sobani@hsc.wvu.edu
学习地点
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West Virginia
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Morgantown、West Virginia、美国、26506
- West Virginia University- Gastroenterology and Hepatology
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接触：
- Zain Sobani, MD
- 电话号码：304-598-6200
- 邮箱：zain.sobani@hsc.wvu.edu
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首席研究员：
- Zain Sobani, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Referred to the WVU Department of Gastroenterology and Hepatology
- Diagnosis of IBS-C
Exclusion Criteria:
- Failure of second-line therapy with secretagogues (linaclotide, lubiprostone, plecanatide, or tenapanor)
- Failure of third-line therapy with tegaserod
- Known debilitating psychiatric illness
- Cognitive impairment
- Pregnancy
- Prisoners
- Active substance use disorder
- Concurrent opioid use
- History of major gastrointestinal surgery resulting in luminal alteration
- History of vagotomy
- Secondary causes of constipation (e.g., opioid use, uncontrolled hypothyroidism, celiac disease)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)
Participants will receive active transcutaneous auricular vagus nerve stimulation (ta-VNS) using the Parasym device (Parasym Health, Inc., London, UK).
The device delivers electrical stimulation to the auricular branch of the vagus nerve via an ear clip.
Stimulation will be administered once daily for 30 minutes over 60 days at a consistent time chosen by the participant.
Stimulation parameters are set at 25 Hz and 250 microseconds, with intensity adjusted to just below the participant's discomfort threshold (0-36 mA).
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Delivery of non-invasive electrical stimulation to the auricular branch of the vagus nerve using the Parasym device.
Stimulation is applied via an ear clip at 25 Hz and 250 microseconds, with intensity titrated to just below discomfort (0-36 mA).
Administered for 30 minutes daily over 60 days.
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假比较器：Sham Transcutaneous Auricular Vagus Nerve Stimulation
Participants will receive sham stimulation using an identical-appearing Parasym device.
The device delivers a brief, low-level electrical output at the start of each session, which ramps down to zero and provides no stimulation for the remainder of the session.
Sessions will last 30 minutes daily for 60 days at a consistent time of the participant's choosing.
The device will look, feel, and sound identical to the active device to maintain blinding.
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Use of a sham Parasym device that mimics active stimulation but delivers only a brief, low-level output at session onset before ramping down to zero for the remainder of the 30-minute session.
Administered daily for 60 days to maintain participant blinding.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60
大体时间：Baseline to Day 60
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Evaluate the effect of transcutaneous auricular vagus nerve stimulation (ta-VNS) on symptom severity in patients with IBS-C using the IBS Symptom Severity Scale (IBS-SSS).
The IBS-SSS assesses abdominal pain severity and frequency, abdominal distension, bowel habit satisfaction, and interference with quality of life.
Scores range from 0 to 500, with higher scores indicating more severe symptoms (≤75 remission, 75-174 mild, 175-299 moderate, 300-500 severe).
The outcome measure is defined as the change in IBS-SSS score from baseline to Day 60.
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Baseline to Day 60
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Change From Baseline in IBS Quality of Life (IBS-QOL) Total Score at Day 60
大体时间：Baseline to Day 60
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Evaluate the impact of ta-VNS on quality of life in patients with IBS-C using the IBS Quality of Life (IBS-QOL) questionnaire.
The IBS-QOL is a 34-item validated instrument scored on a 5-point Likert scale and converted into a total score ranging from 0 to 100, with higher scores indicating better quality of life.
The outcome measure is defined as the change in IBS-QOL total score from baseline to Day 60.
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Baseline to Day 60
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Adverse Events
大体时间：Baseline through Day 60
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Evaluate the safety of ta-VNS in patients with IBS-C by assessing the incidence of adverse events during the 60-day intervention period.
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Baseline through Day 60
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Participant Compliance With ta-VNS Intervention
大体时间：Baseline to Day 60
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Assess participant compliance with the ta-VNS intervention by measuring the number of days the device was used according to the study protocol over the 60-day intervention period.
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Baseline to Day 60
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Change From Baseline in IBS Quality of Life (IBS-QOL) Domain Scores at Day 60
大体时间：Baseline to Day 60
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Evaluate the impact of transcutaneous auricular vagus nerve stimulation (ta-VNS) in patients with IBS-C using the IBS Quality of Life (IBS-QOL) questionnaire domain scores.
The IBS-QOL is a validated instrument that includes the following domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, and relationships.
Each domain score is transformed to a 0 to 100 scale, with higher scores indicating better quality of life.
The outcome measure is defined as the change in each domain score from baseline to Day 60.
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Baseline to Day 60
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
- Shi X, Hu Y, Zhang B, Li W, Chen JD, Liu F. Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. JCI Insight. 2021 Jul 22;6(14):e150052. doi: 10.1172/jci.insight.150052.
- Hou L, Rong P, Yang Y, Fang J, Wang J, Wang Y, Zhang J, Zhang S, Zhang Z, Chen JDZ, Wei W. Auricular Vagus Nerve Stimulation Improves Visceral Hypersensitivity and Gastric Motility and Depression-like Behaviors via Vago-Vagal Pathway in a Rat Model of Functional Dyspepsia. Brain Sci. 2023 Feb 1;13(2):253. doi: 10.3390/brainsci13020253.
- Zhu Y, Xu F, Sun C, Xu W, Li M, Gong Y, Rong P, Lin L, Chen JDZ. Noninvasive Transcutaneous Auricular Vagal Nerve Stimulation Improves Gastric Slow Waves Impaired by Cold Stress in Healthy Subjects. Neuromodulation. 2023 Dec;26(8):1851-1857. doi: 10.1016/j.neurom.2022.03.010. Epub 2022 May 19.
- Liu J, Lv C, Yin M, Zhu M, Wang B, Tian J, Hashimoto K, Yu Y. Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Constipation-Predominant Irritable Bowel Syndrome: A Single-Center, Single-Blind, Randomized Controlled Trial. Am J Gastroenterol. 2024 Dec 17;120(9):2139-2153. doi: 10.14309/ajg.0000000000003257.
- Weronika Górska and Mikołaj Raszek, Auricular versus Cervical Vagus Nerve Stimulation: A Narrative Perspective on Safety, Mechanisms, and Clinical Applicability. MAR Neurology, Neurosurgery & Psychology, 2025. 9(4).
- Almario CV, Sharabi E, Chey WD, Lauzon M, Higgins CS, Spiegel BMR. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年7月1日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.