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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
West Virginia University- Gastroenterology and Hepatology
Morgantown, West Virginia, United States
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
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
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
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
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
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