CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
gammaCore™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04990687
NCT04990687N/ACompleted

Vagal Nerve Stimulation for Treatment Resistant Major Depression

University of Alabama at Birmingham·interventional·Posted Aug 4, 2021·Updated Jul 1, 2024

In Brief

A clinical study evaluating gammaCore™ for Major Depressive Disorder. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The purpose of this study is to 1) explore whether vagal nerve stimulation (nVNS) using a hand- held non-invasive device (gammaCore™) works to treat depression and 2) to confirm gammaCore™'s safety profile.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 4, 2021
Enrollment StartJan 1, 2022
Primary CompletionSep 8, 2023
Study CompletionApr 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.9 years ago

Interventions

gammaCore™device

Implantable VNS (iVNS), the electrical stimulation of the nervous system to modulate or modify function, has been FDA approved in the United States since the late 1990s. Implantable VNS therapy has been approved for use in epilepsy and depression. When treating major depression with implanted VNS, the widely held belief is that chronic stimulation is required for therapeutic effect. In trials of implantable VNS in major depression, more patients respond at 12 months than at 3 months. Once depressed patients respond to VNS, the effects have been demonstrated to continue for up to five years with continued stimulation. This finding suggests that VNS gradually changes brain function through neuroplasticity.