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Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia

Clinical Trial Summary

The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06360900
Study type Interventional
Source Spaulding Rehabilitation Hospital
Contact Andrew Bolender, BA
Phone 617-643-4297
Email abolender@mgh.harvard.edu
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date March 2029
View Details
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