RecruitingNot ApplicableNCT06360900

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


Sponsor

Spaulding Rehabilitation Hospital

Enrollment

80 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria15

  • 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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Interventions

DEVICESensory device

Sensory vagal nerve stimulation

BEHAVIORALSkills Building

Skills Building behavioral therapy

BEHAVIORALHealth Education

Education of FD condition

DEVICESubsensory device

Subsensory vagal nerve stimulation


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06360900


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