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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Sensory vagal nerve stimulation
Skills Building behavioral therapy
Education of FD condition
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGVisceral Sensitivity Index (VSI)
GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes
Time frame: 8 weeks (post-treatment)
Gastric peristaltic velocity
MRI-derived gastric motility outcome
Time frame: 8 weeks (post-treatment)
Nepean Dyspepsia Index (NDI)
FD symptoms severity; score ranging from 0 to 100, with higher scores indicating worse outcomes
Time frame: 8 weeks (post-treatment)
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Subsensory vagal nerve stimulation