Actively Recruiting
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
Led by Spaulding Rehabilitation Hospital · Updated on 2025-11-06
80
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
S
Spaulding Rehabilitation Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Willingness to self-administer daily transcutaneous auricular vagus nerve stimulation sessions
- Willingness to engage in homework during treatment
- Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study sessions
- Diagnosis of functional dyspepsia according to Rome IV criteria for epigastric pain syndrome and postprandial distress syndrome
- Stable medical treatment for functional dyspepsia for at least 1 month before and during the study
You will not qualify if you...
- Previous receipt of cognitive behavioral therapy for gastrointestinal symptoms
- Use of enteral or parenteral feeding
- Previous gastrointestinal surgery
- Electrolyte disturbances
- Kidney dysfunction or renal insufficiency
- Iron overload disorders
- Estimated Glomerular Filtration Rate (eGFR) less than 60
- Use of medications affecting gastrointestinal motility or products containing tetrahydrocannabinol (THC) within 7 days before and during the study (exceptions for some antidepressants)
- History of intellectual disability
- Diabetes, mitochondrial disease, severe autonomic dysfunction, or small fiber polyneuropathy
- Current active clinical acupuncture therapy
- Use of illicit drugs or opioids
- History of arrhythmias
- Current pregnancy or breastfeeding
- Contraindications for magnetic resonance imaging (MRI), including implanted ferromagnetic objects or claustrophobia
- Weight over 450 lbs (MRI table limit)
- Allergy to pineapple (used in test meal during MRI)
- Any condition interfering with study requirements as determined by the Investigator
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, 02129
Actively Recruiting
Research Team
K
Karen Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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