Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C

Официальное название

Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype

Обзор

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.

Вмешательства

• Устройство Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)
  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.
• Устройство Sham Transcutaneous Auricular Vagus Nerve Stimulation
  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.

Первичные конечные точки

• Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60 [Срок оценки: Baseline to Day 60]
• Change From Baseline in IBS Quality of Life (IBS-QOL) Total Score at Day 60 [Срок оценки: Baseline to Day 60]

Вторичные конечные точки (3)

• Incidence of Adverse Events [Срок оценки: Baseline through Day 60]
• Participant Compliance With ta-VNS Intervention [Срок оценки: Baseline to Day 60]
• Change From Baseline in IBS Quality of Life (IBS-QOL) Domain Scores at Day 60 [Срок оценки: Baseline to Day 60]

Критерии участия

Критерии включения

• Referred to the WVU Department of Gastroenterology and Hepatology
• Diagnosis of IBS-C

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Virginia University- Gastroenterology and Hepatology — Morgantown

Публикации

• 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. PMID 36831796
• 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. PMID 35597733
• 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. PMID 39689011
• 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).
• 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. PMID 34138761
• 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. PMID 28826627
• 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. PMID 37595647

Идентификаторы

NCT: NCT07662083 · STUDY00000105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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