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ACTIVE NOT RECRUITING
NCT04448327
NA

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Official title: Sex-Dependent Impact of Transcutaneous Vagal Nerve Stimulation on the Stress Response Circuitry and Autonomic Dysregulation in Major Depression

Key Details

Gender

All

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2021-01-29

Completion Date

2026-05-31

Last Updated

2025-12-29

Healthy Volunteers

No

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

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States