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NCT04448327 · ClinicalTrials.gov registry record · NA
Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression
A NA study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- NA
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT04448327 is a NA study of Major Depressive Disorder that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 62 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04448327, a NA study of Major Depressive Disorder, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Sham tVNS
- DEVICE active tVNS
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04448327
The ClinicalTrials.gov registry entry for NCT04448327 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sham tVNS is the first listed.
NCT04448327 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04448327 about?
NCT04448327 is a clinical study titled "Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression". 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...
What is the current status of trial NCT04448327?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 62 participants. The study started on 2021-01-29. Estimated completion is 2026-05-31.
What conditions does trial NCT04448327 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04448327?
The interventions under investigation include: Sham tVNS (DEVICE), active tVNS (DEVICE).
Who is sponsoring clinical trial NCT04448327?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04448327 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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