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NCT04467164 · ClinicalTrials.gov registry record · NA
Vagus Nerve Stimulation: Integration of Behavior and Cardiac Modulation
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04467164: Completed NA study, sponsored by Massachusetts General Hospital.
NCT04467164 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04467164, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
A functional magnetic resonance imaging (fMRI) analysis was used to evaluate changes in brain activity \[blood oxygenation level-dependent (BOLD) signal\] in response to a visual stress challenge (post- and pre-stimulation). For this analysis a General Lineal Model analsysis with the statistical parametrical software (SPM) was used to model the change in BOLD signals during exposure to negative vs neutral images of the stress tasks. A voxel-wise height threshold of p \< 0.001, and a cluster corr
Interventions
- OTHER exhalatory-gated transcutaneous vagus nerve stimulation (e-RAVANS)
- OTHER Inhalatory-gated transcutaneous vagus nerve stimulation (i-RAVANS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-04-15 |
| Est. Completion | 2018-09-22 |
| Phase | NA |
What the finished NCT04467164 record still lists
NCT04467164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which exhalatory-gated transcutaneous vagus nerve stimulation (e-RAVANS) is the first listed.
NCT04467164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04467164 about?
NCT04467164 is a clinical study titled "Vagus Nerve Stimulation: Integration of Behavior and Cardiac Modulation". 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 episod...
What is the current status of trial NCT04467164?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-04-15. Estimated completion is 2018-09-22.
What interventions are being tested in trial NCT04467164?
The interventions under investigation include: exhalatory-gated transcutaneous vagus nerve stimulation (e-RAVANS) (OTHER), Inhalatory-gated transcutaneous vagus nerve stimulation (i-RAVANS) (OTHER).
Who is sponsoring clinical trial NCT04467164?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04467164's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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