NCT04448327Completed
Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression
Sex-Dependent Impact of Transcutaneous Vagal Nerve Stimulation on the Stress Response Circuitry and Autonomic Dysregulation in Major Depression
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 17 Jun 2020
- Start date
- 29 Jan 2021
- Primary completion date
- 13 Jun 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Depression
- NCT number
- NCT04448327
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 29 Jan 2021 to the primary completion date, 13 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI or tVNS contraindications (e.g. claustrophobia, metallic implants or devices)
Other illness
- 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.)
Age
- Pregnancy (uncommon, given the age of this cohort is 50+ years) due to unknown health risks for the fetus
Other
- Traumatic brain injury with cognitive sequelae
Who the study is looking for
- Current or past diagnosis of recurrent Major Depressive Disorder
Age in the registry: 50 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Charlestown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.