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Major Depressive Disorder / active tVNS / Sham tVNS · Interventional Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed but unpublished randomized controlled trial evaluating transcutaneous vagal nerve stimulation (tVNS) against sham in major depressive disorder. The trial measures changes in brain activity via fMRI and heart rate variability as primary outcomes, with a hypothesis of sex-dependent modulation of stress-response circuitry. No efficacy or safety results are currently available in this registry record.
Interventional, Randomized, Parallel, Double masking, Basic Science purpose. Major Depressive Disorder; age from 50 Years; to 65 Years. Intervention: Active tVNS. Compared with: Sham tVNS — Sham Comparator. n = 62. 1 site: United States.
This is a completed but unpublished randomized controlled trial evaluating transcutaneous vagal nerve stimulation (tVNS) against sham in major depressive disorder. The trial measures changes in brain activity via fMRI and heart rate variability as primary outcomes, with a hypothesis of sex-dependent modulation of stress-response circuitry. No efficacy or safety results are currently available in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial addresses a mechanistic question about tVNS effects on stress-response neural and physiological pathways in MDD. Clinical relevance will depend on whether neuroimaging and physiological changes translate to symptomatic benefit, which this registry record does not address.
This is a completed registry record with no posted results; it describes a planned interventional study using surrogate neurophysiological endpoints (fMRI brain activity, heart rate variability) in a small sample, which constitutes early-phase evidence pending outcome publication.
As stated by the source record.
Quoted from the source exactly as published.
This trial addresses a mechanistic question about tVNS effects on stress-response neural and physiological pathways in MDD. Clinical relevance will depend on whether neuroimaging and physiological changes translate to symptomatic benefit, which this registry record does not address.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04448327). This is a study registration, not published results. Lead sponsor: Massachusetts General Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 62 participants (ACTUAL). Conditions: Major Depressive Disorder. Interventions: DEVICE: active tVNS; DEVICE: Sham tVNS. Primary outcome measures: Change in Brain Activity (Average Beta Weights From Significantly Activated Regions) Evaluated Using Functional Magnetic Resonance Imaging (fMRI) , 1 hour; Percent Change in Normalized High Frequency Power - Heart Rate Variability From Baseline , 1 hour. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.