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Not yet recruitingNCT07890948Updated Oct 23, 2026

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

An interventional study of Nurosym Device in Irritable Bowel Syndrome (IBS), sponsored by Hoag Memorial Hospital Presbyterian. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Hoag Memorial Hospital Presbyterian · Not applicable, Interventional, and Device feasibility

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

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Conditions studied

  • Irritable Bowel Syndrome (IBS)
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In context

Irritable Bowel Syndrome

1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Hoag Memorial Hospital Presbyterian is the lead sponsor of 33 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female adults, aged 18 to 60 years, who can provide written, informed consent.
  2. 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.

  3. Completion of at least 4 of the 7 daily surveys during week prior to study intervention
  4. Average daily abdominal intensity score between 4 and 8 (on a 10-point numeric rating scale) during week prior to study intervention.
  5. Ability to read and speak English fluently.
  6. Ability to provide own written informed consent (or assent) and comply with the requirements of the study.
  7. Daily access to a computer with internet for online surveys

Exclusion criteria

Exclusion Criteria:

  1. Age under 18 years or over 60 years
  2. Those who cannot provide informed consent.
  3. Those who cannot read or speak English fluently.
  4. Organic medical conditions associated with abdominal pain, including inflammatory bowel disease, celiac disease, peptic ulcer disease, chronic liver disease, cancer, or endometriosis.
  5. 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.
  6. Those who have permanent implanted metal objects (e.g., stimulator, implants).
  7. History of surgery involving the vagus nerve
  8. History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months prior to study entry
  9. Use of chronic opioids, benzodiazepines, glucagon-like peptide-1 receptor agonists
  10. Underlying psychiatric conditions other than anxiety and depression on stable controlled medications in the past 6 months prior to study entry
  11. 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
  12. 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
  13. Dermatological conditions affecting the ear, face, or neck region, cuts or abrasions to the external ear that would interfere with ability to wear taVNS.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    ACTIVE

    Participants will receive 8 weeks of active stimulation (ACTIVE)

    Device: Nurosym Device

  • Sham comparator
    SHAM

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

    Device: Nurosym Device

Interventions

  • DeviceNurosym Device

    Neuromodulation with Transcutaneous Auricular Vagus Nerve Stimulation

06

What researchers measure

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

    Time frame: 21 Weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 41024200 ↗
  • 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. PubMed 37288650 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890948
Lead sponsor
Hoag Memorial Hospital Presbyterian
Responsible party
Catherine Ngo (Gastroenterologist, Hoag Memorial Hospital Presbyterian) — Principal investigator
First posted
Oct 23, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Catherine Ngo, M.D.
Contact
catherine.ngo@hoag.org
949-764-7569

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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