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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Device: Sensory device; Behavioral: Skills Building; Behavioral: Health Education; Device: Subsensory device

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Lin; Phone Number: 617-724-6642; Email: klin16@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Karen Lin; Phone Number: 617-724-6642; Email: klin16@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensory device + Skills Building	Device: Sensory device; Sensory vagal nerve stimulation; Behavioral: Skills Building; Skills Building behavioral therapy
Active Comparator: Sensory device + Health Education	Device: Sensory device; Sensory vagal nerve stimulation; Behavioral: Health Education; Education of FD condition
Active Comparator: Subsensory device + Skills Building	Behavioral: Skills Building; Skills Building behavioral therapy; Device: Subsensory device; Subsensory vagal nerve stimulation
Sham Comparator: Subsensory device + Health Education	Behavioral: Health Education; Education of FD condition; Device: Subsensory device; Subsensory vagal nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral Sensitivity Index (VSI)	GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes	8 weeks (post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nepean Dyspepsia Index (NDI)	FD symptoms severity; score ranging from 0 to 100, with higher scores indicating worse outcomes	8 weeks (post-treatment)
Gastric peristaltic velocity	MRI-derived gastric motility outcome	8 weeks (post-treatment)

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2024P000849; R01DK136243 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No