Actively Recruiting
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
Led by Massachusetts General Hospital · Updated on 2025-10-27
65
Participants Needed
1
Research Sites
487 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.
CONDITIONS
Official Title
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers, female and male, between 18 and 65 years of age.
- Healthy volunteers must be able to undergo MRI for up to 2 hours.
- Functional dyspepsia patients must have diagnosis per Rome III criteria for PDS and EPS subtypes.
- Gastroparesis patients must have symptoms for at least 12 weeks, idiopathic cause, and abnormal gastric emptying tests within the last 6 months.
- Stable medical treatment for functional dyspepsia or gastroparesis for at least 1 month before and during the study.
- Avoidance of alcohol, nicotine, and caffeine for 24 hours before study sessions.
You will not qualify if you...
- History of gastric or esophageal surgery.
- Use of alternative treatments like acupuncture or hypnosis within 2 weeks before or during the study.
- Use of illicit drugs or opioids.
- History of heart arrhythmias.
- Presence of implanted pacemaker.
- Epilepsy or history of seizures.
- Gastroparesis patients unable to complete gastric emptying tests or allergic to eggs.
- Pregnancy, nursing, or plans to become pregnant.
- Inability to provide informed consent.
- Body mass index over 32 or weight above 235 lbs.
- Contraindications for MRI including implanted metal devices, recent surgery, tattoos with metallic ink above the nipple line, certain medical conditions, claustrophobia, and use of some transdermal patches.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Andrew Bolender, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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