Vagal Nerve Stimulation for Treatment Resistant Major Depression

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

September 8, 2023

Study Completion Date

April 3, 2024

Conditions
Major Depressive Disorder
Interventions
DEVICE

gammaCore™

"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."

Trial Locations (1)

35294

The University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER

NCT04990687 - Vagal Nerve Stimulation for Treatment Resistant Major Depression | Biotech Hunter | Biotech Hunter