Mapping Auricular Vagus Nerve Circuitry

Mass General Brigham

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy

Treatments: Device: active TEAS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00200889

3OT2OD023867-01S2 (U.S. NIH Grant/Contract)

2009P002177

Details and patient eligibility

About

This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18-65
• Functional dyspepsia

Exclusion criteria

• Any condition contraindicating an fMRI brain scan

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Congruent

Experimental group

Description:

Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature.

Treatment:

Device: active TEAS

Incongruent

Experimental group

Description:

Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature.

Treatment:

Device: active TEAS