Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation

Who is this study for? Patients with Dyspepsia, Gastroparesis
What treatments are being studied? taVNS
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Volunteers, female and male, between 18 and 65 years of age.

• For healthy volunteers, ability to undergo MRI for up to 2 hours.

• For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.

• 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.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Andrew Bolender, BA
abolender@mgh.harvard.edu
617-643-4297
Time Frame
Start Date: 2018-11-30
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 65
Treatments
Experimental: taVNS
Active or inactive taVNS
Authors
Brad Kuo, Vitaly Napadow
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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