Mapping Auricular Vagus Nerve Circuitry
Purpose
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Adults 18-65 - Functional dyspepsia
Exclusion Criteria
- Any condition contraindicating an fMRI brain scan
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized 1:1 to "Congruent" or "Incongruent" briefing groups. The Congruent group receives briefings including expectations of stimulation effects on gastric motility consistent with prior research in the literature. The Incongruent group receives briefings including expectations of stimulation effects on gastric motility inconsistent with prior research in the literature.
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- Participants are not made aware of the expectation manipulation nor their group assignment until the end of the final visit, at which point they are debriefed. Outcomes assessors will be blind to group assignments until analysis is complete.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Congruent |
Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature. |
|
|
Experimental Incongruent |
Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.