Mapping the effects of noninvasive nerve stimulation on brain and stomach activity
Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
This study is testing how a gentle nerve stimulation technique affects brain and stomach activity in healthy adults to better understand its effects on the body.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT00200889 on ClinicalTrials.gov |
What this trial studies
This study investigates how noninvasive nerve stimulation, specifically transcutaneous electro-acupoint stimulation, influences brain, stomach, and autonomic functions in healthy adults. By utilizing advanced imaging techniques such as functional MRI and gastric MRI, the research aims to understand the underlying mechanisms of neuromodulation. Participants will undergo three fMRI scans while receiving varying parameters of stimulation, with continuous monitoring of physiological responses including heart rate and gastric activity.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-65.
Not a fit: Patients with conditions that contraindicate an fMRI brain scan will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of neuromodulation and its potential therapeutic applications for gastrointestinal and autonomic disorders.
How similar studies have performed: While the approach of using noninvasive nerve stimulation is gaining interest, this specific study's methodology is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18-65 * Functional dyspepsia Exclusion Criteria: * Any condition contraindicating an fMRI brain scan
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Vitaly Napadow, PhD — Harvard University
- Study coordinator: Andy Bolender, B.A.
- Email: abolender@mgh.harvard.edu
- Phone: 617-643-4297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.