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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: Active NA study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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 during transcutaneous vagus nerve stimulation. For this analysis a General Lineal Model analysis 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 task. A voxel-wise height threshold of p\<0.001, and
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 |
What the registry record for NCT04448327 still lists
NCT04448327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04448327's enrollment target sits among peer trials
62 165th of 282 higher than 116 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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