NCT03603730

Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.

Detailed description

The primary aims of this study are to 1) investigate the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain-gut signaling using a liquid meal test in functional dyspepsia (FD) and gastroparesis (GP) patients using combined gastric, autonomic and neuroimaging measures, and 2) evaluate the effectiveness of taVNS on FD and GP symptoms. A total of 25 FD and 25 GP patients will be enrolled in this study, both females and males, ranging between 18 and 65 years of age. There will be multiple study visits consisting of a screening, baseline testing, consumption of a liquid meal, and fMRI brain and gut imaging sessions. Visits will include active and inactive taVNS delivered to the outer ear at a moderate, non-painful level.

Conditions

• Dyspepsia
• Gastroparesis

Interventions

Type	Name	Description
DEVICE	taVNS	Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.

Timeline

• Start date: 2018-11-30
• Primary completion: 2027-06-30
• Completion: 2028-03-31
• First posted: 2018-07-27
• Last updated: 2025-10-27

Locations

1 site across 1 country: United States