Irritable Bowel Syndrome (IBS)NCT07890948
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
A study testing Nurosym Device in people with Irritable Bowel Syndrome (IBS), run by Hoag Memorial Hospital Presbyterian.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Nurosym Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
- Being tested
- Nurosym Device
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurosym DeviceDevice
Neuromodulation with Transcutaneous Auricular Vagus Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE | Experimental | Participants will receive 8 weeks of active stimulation (ACTIVE) Receives: Device: Nurosym Device |
| SHAM | Sham comparator | Participants will receive 4 weeks of sham followed by 4 weeks of active stimulation Receives: Device: Nurosym Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Ngo, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890948
- Sponsor's protocol ID
- 228-25-GI
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 41024200Song 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
- ClinicalTrials.gov ID
- NCT07890948
- Acronym / sponsor ID
- 228-25-GI
- Conditions
- Irritable Bowel Syndrome (IBS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVE | Experimental | Device: Nurosym DeviceParticipants will receive 8 weeks of active stimulation (ACTIVE) |
| SHAM | Sham comparator | Device: Nurosym DeviceParticipants will receive 4 weeks of sham followed by 4 weeks of active stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurosym DeviceNeuromodulation with Transcutaneous Auricular Vagus Nerve Stimulation | Device | ACTIVE, SHAM |
Primary outcome
IBS-SSS
Time frame: 21 Weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Results publication: PubMed 41024200Wang 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.
- Results publication: PubMed 37288650Song 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nurosym Device in people with Irritable Bowel Syndrome (IBS), run by Hoag Memorial Hospital Presbyterian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Ngo, M.D. (949-764-7569, catherine.ngo@hoag.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-SSS (time frame: 21 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07890948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.