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

Description

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

Major Depressive Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Charlestown

Massachusetts General Hospital, Charlestown, Massachusetts, United States, 02129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Current or past diagnosis of recurrent Major Depressive Disorder
  • * History of neuroleptic use
  • * Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar I disorder)
  • * Active suicidal ideation with intent and/or plan or history of a suicide attempt within the last year
  • * Moderate or severe substance use disorder within the past 12 months
  • * Diagnosis of significant cardiovascular or cerebrovascular disease (e.g. congestive heart failure, stroke, cardiac conduction disorders, history of asystole or non-sustained ventricular tachycardia)
  • * Diseases affecting the CNS (e.g. MS, epilepsy, neurodegenerative diseases, etc.)
  • * Traumatic brain injury with cognitive sequelae
  • * MRI or tVNS contraindications (e.g. claustrophobia, metallic implants or devices)
  • * Pregnancy (uncommon, given the age of this cohort is 50+ years) due to unknown health risks for the fetus

Ages Eligible for Study

50 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Ronald G Garcia, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-12-31