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Trans Auricular Vagal Nerve Stimulation for IBS-C

This study is testing a non-invasive device called Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) for adults with constipation-predominant Irritable Bowel Syndrome (IBS-C). You would use an ear clip device daily for 60 days. Half of the participants will receive active ta-VNS, and the other half will receive a sham (inactive) device. The researchers want to see if ta-VNS can improve your IBS symptoms and your quality of life. To join, you must have IBS-C and be referred to the WVU Department of Gastroenterology and Hepatology. The study is currently unclear about its recruitment status.

Study design
This is an interventional study with 80 planned participants. You would be randomly assigned to receive either the active ta-VNS device or a sham device, meaning neither you nor the researchers will know which treatment you are getting.
What's involved
You would use the ta-VNS device for 30 minutes daily over 60 days. Your IBS symptoms and quality of life will be assessed at the beginning and end of this 60-day period.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at Day 60, which is the end of the treatment period.

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NCT07662083

Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C

Not Yet Recruiting
NAAges 18+InterventionalTreatment
West Virginia University
~80 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)Sham Transcutaneous Auricular Vagus Nerve Stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60
Measured over Baseline to Day 60
+1 more outcome measured

Conditions

Irritable Bowel Syndrome (IBS-C)

Explore related trials

Irritable Bowel Syndrome

Where it's being run

1 sites across 1 states
West Virginia1

Who to contact

Zain Sobani, MD
[email protected]
304-598-6200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

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

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