Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Stomach activity during gastric magnetic resonance imaging (MRI)
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
Detailed Description
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring. This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
Investigators
Vitaly Napadow, Ph.D., Lic.Ac.
Assistant Professor
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Adults 18-65
- •Functional dyspepsia
Exclusion Criteria
- •Any condition contraindicating an fMRI brain scan
Outcomes
Primary Outcomes
Stomach activity during gastric magnetic resonance imaging (MRI)
Time Frame: 30 minutes
Gastric accommodation and sensitivity change between active and inactive auricular tVNS
Brain activity during functional magnetic resonance imaging (fMRI)
Time Frame: 1 hour
Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS
Secondary Outcomes
- Electrogastrography (EGG)(2 hours)
- Electrocardiography (ECG)(2 hours)
- Respiration(2 hours)
- Skin Conductance Levels (SCL)(2 hours)