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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04467164
The ClinicalTrials.gov registry entry for NCT04467164 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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