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Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression

NCT04448327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-29

No results posted yet for this study

Summary

This study will identify the sex-dependent impact of expiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and associated physiology in major depressive disorder (MDD). We will evaluate a sample of 80 adults with recurrent MDD randomized to receive active or sham expiratory-gated tVNS during a functional magnetic resonance imaging (fMRI) session, with simultaneous mood and physiological assessments. We hypothesize that expiratory-gated tVNS will effectively modulate, in a sex-dependent manner, specific brainstem-cortical pathways of the stress circuitry and attenuate physiological deficits in MDD.

Conditions

Interventions

DEVICE

active tVNS

non-painful electrical stimulation of the auricle for 30 minutes during a functional magnetic resonance imaging session

DEVICE

Sham tVNS

Sham stimulation of the auricle for 30 minutes during a functional magnetic resonance imaging session

Sponsors & Collaborators

Principal Investigators

  • Ronald G Garcia, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2025-06-13
Completion
2025-06-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448327 on ClinicalTrials.gov