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Irritable Bowel Syndrome (IBS-C)NCT07662083

Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) in people with Irritable Bowel Syndrome (IBS-C), run by West Virginia University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome (IBS-C)
What is being tested?
Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
Jul 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zain Sobani, MD contact

304-598-6200

zain.sobani@hsc.wvu.edu

United States1 site

  • West Virginia University- Gastroenterology and Hepatology

    Morgantown, West Virginia, 26506

    Zain Sobani, MD, 304-598-6200, zain.sobani@hsc.wvu.edu

    Zain Sobani, MD

Other trials in United States

About this study

Official title: 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.

Being tested
Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation
Keywords
Trans Auricular Vagal Nerve Stimulation
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)Device

    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.

  • Sham Transcutaneous Auricular Vagus Nerve StimulationDevice

    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.

Study groups in NCT07662083
Study groupRoleWhat they receive
Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)ExperimentalParticipants 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).
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)
Sham Transcutaneous Auricular Vagus Nerve StimulationSham comparatorParticipants 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.
Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60

    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.

    Measured: Baseline to Day 60

  2. Change From Baseline in IBS Quality of Life (IBS-QOL) Total Score at Day 60

    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.

    Measured: Baseline to Day 60

Secondary outcomes (3)

  1. Incidence of Adverse Events

    Evaluate the safety of ta-VNS in patients with IBS-C by assessing the incidence of adverse events during the 60-day intervention period.

    Measured: Baseline through Day 60

  2. Participant Compliance With ta-VNS Intervention

    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.

    Measured: Baseline to Day 60

  3. Change From Baseline in IBS Quality of Life (IBS-QOL) Domain Scores at Day 60

    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.

    Measured: Baseline to Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07662083
Sponsor's protocol ID
STUDY00000105
Status last verified
Jun 2026
First submitted
17 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 37595647

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) in people with Irritable Bowel Syndrome (IBS-C), run by West Virginia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zain Sobani, MD (304-598-6200, zain.sobani@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60 (time frame: Baseline to Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07662083, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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