A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)
Summary
The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications. The study involves the use of Brainsway H-Coil Deep TMS System and will assess clinical outcomes in participants with Major Depressive Disorder.
Why it matters
This trial represents an important advancement in neurotechnology for treating Major Depressive Disorder. If successful, the device-based intervention could provide a new therapeutic option for patients who have not responded adequately to conventional treatments or therapies. The study results may inform future regulatory approval pathways and establish clinical precedent that could benefit broader patient populations with similar conditions.
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