Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
Spaulding Rehabilitation Hospital
Summary
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 (…
Interventions
- DeviceSensory device
Sensory vagal nerve stimulation
- BehavioralSkills Building
Skills Building behavioral therapy
- BehavioralHealth Education
Education of FD condition
- DeviceSubsensory device
Subsensory vagal nerve stimulation
Location
- Massachusetts General HospitalBoston, Massachusetts