NeuroQore Inc.
Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions. The goal of this multi-site sham-controlled double-blinded randomized clinical trial is to evaluate the safety and effectiveness of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder. The accelerated protocol of this study will involve the same currently FDA-cleared 19-min treatment session offered three times in a single day, with no additional treatment sessions.
Study Description: This multi-site sham-controlled double-blinded randomized study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder. Currently cleared protocol with the FDA (the Standard of Care Protocol) is one 19-min treatment session a day for 5 days/week for 6 weeks. The accelerated protocol will involve the same 19-min treatment session offered three times in a single day, with no additional treatment sessions. Primary Objective…
Inclusion Criteria: 1. Males or females aged 22-85. 2. Current diagnosis of major depressive disorder according to the criteria defined in the current Diagnosis and Statistical Manual of Mental Disorders (DSM-V) without psychotic features. The diagnosis of DSM-5 criteria-defined MDD will be made by a psychiatrist in light of a comprehensive psychiatric evaluation and other available clinical data. 3. Drug-resistant MDD (lack of improvement on antidepressant medication in the current episode, despite adequate dose and duration and adherence to treatment). 4. MADRS score \> 20 at baseline and i…
1 Day x 3 Sessions of 19-minutes active rTMS treatment, with 60 minutes rest between sessions.
1 Day x 3 Sessions of 19-minutes sham rTMS treatment, with 60 minutes rest between sessions. It simulates the treatment regimen but blocks the treatment from reaching the target in Cortex.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.