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.
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
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
Spaulding Rehabilitation Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator