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

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT04448327

Run by

Massachusetts General Hospital

People needed

62

Starts

2021-01-29

Expected to finish

2025-06-14

Last updated by the study team

2026-04-29

Who can join

Age: 50 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current or past diagnosis of recurrent Major Depressive Disorder

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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