Mapping Auricular Vagus Nerve Circuitry

Early Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Device: active TEAS

• Registration Number: NCT00200889
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Study Start: 2023-08-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults 18-65
• Functional dyspepsia

Exclusion Criteria

• Any condition contraindicating an fMRI brain scan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Congruent	active TEAS	Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature.
Incongruent	active TEAS	Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature.

Primary Outcome Measures

Name	Time	Method
Stomach activity during gastric magnetic resonance imaging (MRI)	30 minutes	Gastric accommodation and sensitivity change between active and inactive auricular tVNS
Brain activity during functional magnetic resonance imaging (fMRI)	1 hour	Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS

Secondary Outcome Measures

Name	Time	Method
Electrogastrography (EGG)	2 hours	We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
Electrocardiography (ECG)	2 hours	We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex.
Respiration	2 hours	Respiration will be measured in beats per minute (bpm).
Skin Conductance Levels (SCL)	2 hours	SCL will be measured in volts per second.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States