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Could a nerve zap and talk therapy soothe your upset stomach?

NCT ID NCT06360900

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 16, 2026 · Updated 5 times

Summary

This study tests whether combining a nerve-stimulating device (placed on the ear) with behavioral therapy can reduce stomach pain and anxiety in people with functional dyspepsia, a condition where the stomach feels upset without a clear cause. Researchers will track symptoms and stomach movement using MRI. The trial involves 80 adults who will attend weekly therapy sessions online and use the device daily at home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vagal nerve stimulation device and behavioral therapy
What this could lead to
If it works, this could offer a new drug-free way to manage functional dyspepsia symptoms and related anxiety.
What could go wrong
This is an early-stage study with only 80 people, so results may not apply to everyone. The device and therapy may not provide significant relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age 18-65 years old (inclusive) * Ability to give written consent and participate in behavioral intervention in English * Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment * Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session * Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes * Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period Exclusion Criteria: * Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms * Enteral or parenteral feeding * Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders * Estimated Glomerular Filtration Rate (eGFR) \< 60 * Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study * Intellectual disability by history * Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy * No active clinical acupuncture therapy * Illicit drugs or opioid usage * History of arrhythmias * Current pregnancy/breastfeeding * Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia) * Weight \> 450 lbs. (limit of the MRI table) * Allergy to pineapple (used in the test meal during MRI) * Any other condition interfering with study requirements, according to the Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02129, United States

    Contact Email: •••••@•••••

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