At a glance
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A Prospective, Multicenter, Double-Blind, Sham-Controlled Adaptive Design Study to Confirm the Safety and Efficacy of NEST sTMS in Subjects With Major Depressive Disorder Who Have Not Responded to at Least One Antidepressant Medication in the Current Episode
In Brief
A clinical study evaluating Synchronized Transcranial Magnetic Stimulation (sTMS) and Sham Stimulation for Depressive Disorder and 4 related conditions. Completed, enrolled 121 participants across 14 sites.
Detailed Summary
This is a double-blind, sham controlled, multi-center study to confirm the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of patients currently experiencing an episode of depression who have failed to respond to at least one (1) antidepressant medication. Patients will be randomly assigned to either active or sham therapy and will undergo daily treatments for a period of time. Following completion of blinded treatments, patients may be eligible for a course of open label treatments.
Study Details
Timeline
Interventions
sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF).
Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.