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Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C

ConditionIrritable Bowel Syndrome (IBS-C)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Referred to the WVU Department of Gastroenterology and Hepatology

Diagnosis of IBS-C

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 Stimulation

    Device

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)Experimental treatment 1 intervention
Group B: Sham Transcutaneous Auricular Vagus Nerve StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
Baseline to Day 60

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Baseline to Day 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West Virginia University

Lead sponsor

Source ClinicalTrials.gov

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