NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY

NCT07890948 | Not Yet Recruiting

• 1 other identifier: 228-25-GI
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, single-blind, sham-controlled crossover study evaluating the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in adult patients with IBS. Two intervention groups will receive the investigational NurosymTM device and be randomized (1:1) to either the ACTIVE or SHAM crossover taVNS group. After randomization, participants will receive 8 weeks of active stimulation (ACTIVE) or 4 weeks of sham followed by 4 weeks of active stimulation (SHAM crossover).

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

• IBS-SSS

  Change in the IBS-SSS from baseline (week 1) to the end of week 5 and week 9, and extended follow up at the end of week 21

  21 Weeks

Study Arms (2)

ACTIVE

EXPERIMENTAL

Participants will receive 8 weeks of active stimulation (ACTIVE)

Device: Nurosym Device

SHAM

SHAM COMPARATOR

Participants will receive 4 weeks of sham followed by 4 weeks of active stimulation

Device: Nurosym Device

Interventions

Nurosym Device DEVICE

Neuromodulation with Transcutaneous Auricular Vagus Nerve Stimulation

ACTIVE; SHAM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female adults, aged 18 to 60 years, who can provide written, informed consent.
• A diagnosis of IBS according to Rome IV criteria, as follows:
• a. Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: i. Related to defecation. ii. Associated with a change in stool frequency. iii. Associated with a change in stool from (appearance). b. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
• Completion of at least 4 of the 7 daily surveys during week prior to study intervention
• Average daily abdominal intensity score between 4 and 8 (on a 10-point numeric rating scale) during week prior to study intervention.
• Ability to read and speak English fluently.
• Ability to provide own written informed consent (or assent) and comply with the requirements of the study.
• Daily access to a computer with internet for online surveys

You may not qualify if:

• Age under 18 years or over 60 years
• Those who cannot provide informed consent.
• Those who cannot read or speak English fluently.
• Organic medical conditions associated with abdominal pain, including inflammatory bowel disease, celiac disease, peptic ulcer disease, chronic liver disease, cancer, or endometriosis.
• Those who are pregnant, lactating, or intending to become pregnant during study period. Women of childbearing potential who are unwilling or unable to use effective contraception during the study period will also be excluded.
• Those who have permanent implanted metal objects (e.g., stimulator, implants).
• History of surgery involving the vagus nerve
• History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months prior to study entry
• Use of chronic opioids, benzodiazepines, glucagon-like peptide-1 receptor agonists
• Underlying psychiatric conditions other than anxiety and depression on stable controlled medications in the past 6 months prior to study entry
• Underlying neurological or neuropathic conditions, including history of seizures, cerebrovascular accident, uncontrolled migraines, traumatic brain injury, hydrocephalus, multiple sclerosis, movement disorder, complex regional pain syndrome, fibromyalgia
• Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, metallic intrauterine device, metal braces, facial tattoos and/or metal objects above the level of the neck
• Dermatological conditions affecting the ear, face, or neck region, cuts or abrasions to the external ear that would interfere with ability to wear taVNS.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Related Publications (2)

• Wang K, Alam MJ, Lan X, Li F, Chen JDZ. Efficacy and mechanisms of neuromodulation in the treatment of irritable bowel syndrome. Bioelectron Med. 2025 Sep 30;11(1):23. doi: 10.1186/s42234-025-00186-5.

  PMID: 41024200 RESULT

• Song G, Trujillo S, Fu Y, Shibi F, Chen J, Fass R. Transcutaneous electrical stimulation for gastrointestinal motility disorders. Neurogastroenterol Motil. 2023 Nov;35(11):e14618. doi: 10.1111/nmo.14618. Epub 2023 Jun 8.

  PMID: 37288650 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Catherine Ngo, M.D.

CONTACT

949-764-7569; catherine.ngo@hoag.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10