Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
17 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zain Sobani, MD
- Telefonnummer: 304-598-6200
- E-post: zain.sobani@hsc.wvu.edu
Studieorter
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University- Gastroenterology and Hepatology
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Kontakt:
- Zain Sobani, MD
- Telefonnummer: 304-598-6200
- E-post: zain.sobani@hsc.wvu.edu
-
Huvudutredare:
- Zain Sobani, MD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Sham Comparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of Adverse Events
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 maj 2027
Avslutad studie (Beräknad)
1 juli 2027
Studieregistreringsdatum
Först inskickad
17 juni 2026
Först inskickad som uppfyllde QC-kriterierna
17 juni 2026
Första postat (Faktisk)
23 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00000105
Plan för individuella deltagardata (IPD)
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NEJ
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Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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