Combining gentle ear vagus nerve stimulation with online support to ease functional dyspepsia
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
This trial will test whether daily mild ear vagus nerve stimulation plus weekly online support sessions can help adults with functional dyspepsia reduce stomach pain and bothersome fullness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06360900 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–65 diagnosed with functional dyspepsia by Rome IV criteria, on stable treatment, who can do daily home taVNS, attend weekly online sessions, and complete homework are the ideal candidates.
Not a fit: People with prior CBT for gastrointestinal symptoms, significant renal dysfunction (eGFR < 60), prior gastrointestinal surgery, reliance on enteral/parenteral feeding, or those unable to complete daily stimulation or weekly video visits are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this combined device-and-support approach could reduce dyspeptic symptoms and improve daily functioning using a noninvasive at-home therapy.
How similar studies have performed: Small studies of taVNS and combined behavioral interventions for functional gastrointestinal disorders have shown promising but limited results, making this combined approach relatively novel and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Karen Lin
- Email: klin16@mgh.harvard.edu
- Phone: 617-724-6642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.