N/A
N=20
Vagus Nerve Stimulation: Integration of Behavior and Cardiac Modulation
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04467164 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Brain Activity Changes (Average Differences in Beta Weights From Significantly Activated Regions: Post-stimulation Minus Pre-stimulation) Evaluated Using Functional Magnetic Resonance Imaging. — 0.60; -0.05; 0.28; -0.16 Beta weight difference — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- exhalatory-gated transcutaneous vagus nerve stimulation (e-RAVANS) (Other); Inhalatory-gated transcutaneous vagus nerve stimulation (i-RAVANS) (Other)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Activity Changes (Average Differences in Beta Weights From Significantly Activated Regions: Post-stimulation Minus Pre-stimulation) Evaluated Using Functional Magnetic Resonance Imaging. |
0.60; -0.05; 0.28; -0.16; 0.44; -0.24 | 0.03 sig |
| SECONDARY Change in Depressive Symptoms Assessed by the Beck Depression Inventory (1 Hour Post Intervention Minus Baseline) |
-8.21; -3.58 | 0.03 sig |
| SECONDARY Changes in Cardiac Autonomic Function (Percent Change in Normalized High-frequency Power of Heart Rate Variability (HFn-HRV): Post-stimulation Versus Pre-stimulation) |
28.1; -0.31 | 0.01 sig |
Summary
This study characterized the impact of respiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry, vagal tone and depressed mood in patients with major depressive disorder (MDD). Twenty premenopausal women with recurrent MDD in an active episode were recruited into a single-blind cross-over study that included two functional MRI visits within a one week period with simultaneous mood and physiological assessments. Randomization to exhalatory- or inhalatory-gated tVNS was performed to control for order effects. The study hypothesis was that exhalatory-gated tVNS would have a significantly greater impact on the regulation of brain activity in stress response circuitry, vagal tone and depressed mood in MDD patients compared to inhalation-gated tVNS. This is not a clinical trial aimed to test a medical device, but a basic experimental study oriented to understand the effects of vagal afference modulation on brain and cardiovagal physiological response to stress in major depression.
Eligibility Criteria
Inclusion Criteria: Recurrent MDD diagnosis (≥ 2 episodes) with a current active depressive episode.
Exclusion Criteria
- History of Axis I psychiatric diagnosis other than MDD or anxiety disorder - e.g., substance use disorder, psychotic disorder, or bipolar disorder.
- Current Suicidal Ideation with intent and/or plan or history of suicide attempt within the last year
- Use of psychotropic medications within four weeks prior to study with the exception of Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Norepinephrine Reuptake Inhibitors (SNRIs) class of antidepressant medication only
- Use of Tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and Atypical agents
- History of cardiovascular disease
- History of neuroleptic use
- Past history of substance abuse or dependence within the past 12 months (excludes nicotine)
- Bleeding disorder or use of anticoagulants.
- Pregnancy
- Metallic implants or devices contraindicating magnetic resonance imaging.
- Use of beta blockers
Data sourced from ClinicalTrials.gov (NCT04467164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.