Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C

Conditions

• Irritable Bowel Syndrome (IBS-C)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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).
• 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.

Primary Outcome Measure

Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60 [ Time Frame: Baseline to Day 60 ]

Central Contacts

• Zain Sobani, MD
  304-598-6200
  [email protected]

Locations (1)

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