Combining gentle ear vagus nerve stimulation with online support to ease functional dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults meeting Rome IV criteria for functional dyspepsia (both epigastric pain syndrome and postprandial distress syndrome subtypes) will self-administer daily transcutaneous auricular vagus nerve stimulation (taVNS) at home while participating in weekly live-video sessions that provide skills building and health education. The intervention combines a sensory/subsensory stimulation device with behavioral support and homework to target gut–brain pathways. Participants must be English-speaking, aged 18–65, on stable FD medications, and able to comply with daily device use and weekly telehealth visits. Key exclusions include prior CBT for GI symptoms, significant renal impairment (eGFR < 60), prior GI surgery, enteral/parenteral feeding, or other listed medical contraindications.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Luca McKerley Coronado
• Email: convergestudy@mgb.org
• Phone: 857-238-0962

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa

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• Prevalence and possible role of non-H. pylori Helicobacter species in gastric conditions and cancers

  Researchers will test stomach tissue from people with functional dyspeasia, various gastritis conditions, gastric cancer, and bariatric patients to see if non-H. pylori Helicobacter species are present.

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• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

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• Prevalence of Functional Dyspepsia in a Rural Community in Bangladesh

  This study tests how common functional dyspepsia is in a rural Bangladeshi community among adults who live there.

  Recruiting Bangladesh Medical University · Dhaka · NCT07694778

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.