Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome (IBS-C). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype
Overview
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60 [Time frame: Baseline to Day 60]
- Change From Baseline in IBS Quality of Life (IBS-QOL) Total Score at Day 60 [Time frame: Baseline to Day 60]
Secondary outcome measures (3)
- Incidence of Adverse Events [Time frame: Baseline through Day 60]
- Participant Compliance With ta-VNS Intervention [Time frame: Baseline to Day 60]
- Change From Baseline in IBS Quality of Life (IBS-QOL) Domain Scores at Day 60 [Time frame: Baseline to Day 60]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- West Virginia University- Gastroenterology and Hepatology — Morgantown
Publications
- 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
Identifiers
NCT: NCT07662083 · STUDY00000105