CompletedNot Applicable

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

United States62 participantsStarted 2021-01-29

Plain-language 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.

Who can participate

Age range

50 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Current or past diagnosis of recurrent Major Depressive Disorder Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain activity during functional magnetic resonance imaging (fMRI)

Timeframe: 1 hour

Cardiac autonomic function during functional magnetic resonance imaging (fMRI)

Timeframe: 1 hour

Trial details

NCT IDNCT04448327

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-13

View on ClinicalTrials.gov More Major Depressive Disorder trials