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Study of Vagal Stimulation and Support Therapy for Functional Dyspepsia

This study is looking at new ways to help people with functional dyspepsia (a condition causing ongoing stomach upset without a clear cause). We are testing two approaches together: a sensory device that stimulates the vagal nerve (a nerve that connects your brain to your gut), and support therapy. The support therapy includes both skills building and education about functional dyspepsia. We are also looking at a subsensory device for vagal nerve stimulation. To join, you need to be between 18 and 65 years old, able to give written consent, and willing to participate in weekly online sessions and daily at-home stimulation. The main goal is to see how these treatments affect your visceral sensitivity (how sensitive your gut is) after 8 weeks. This study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 80 participants.
What's involved
You would attend weekly treatment sessions over live video, perform daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS), and engage in homework during treatment.
Compensation
Not stated in the trial record.
Follow-up
Your visceral sensitivity will be measured at 8 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06360900

Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia

Recruiting
NAAges 18–65InterventionalTreatment
Spaulding Rehabilitation Hospital
~80 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Sensory deviceSkills BuildingHealth EducationSubsensory device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visceral Sensitivity Index (VSI)
Measured over 8 weeks (post-treatment)

Conditions

Functional Dyspepsia

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NCT06360900

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Luca McKerley Coronado
[email protected]
857-238-0962
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Visceral Sensitivity Index (VSI)8 weeks (post-treatment)

    GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes