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Recruiting NCT03603730

Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Trial Parameters

Condition Dyspepsia
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2018-11-30
Completion 2027-06-30
Interventions
taVNS

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1. Volunteers, female and male, between 18 and 65 years of age. 2. For healthy volunteers, ability to undergo MRI for up to 2 hours. 3. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes. 4. For Gastroparesis patients, diagnosis will include the following criteria: * symptoms of gastroparesis of at least 12 weeks duration (does not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness * an idiopathic etiology * abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters® protocol within the last 6 months with either a gastric emptying rate \> 60% retention at 2 hours and/or \>10% retention at 4 hours. 4\) Stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month before study and during the study period. 5\) Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session. Exclusion Crit

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