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Open Label Optimization Study
Sponsor: Magnus Medical
Summary
The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®
Official title: An Open Label Optimization Study to Assess the Effectiveness of the SAINT® Neuromodulation System (NMS) to Treat Major Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2023-04-06
Completion Date
2027-04-15
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
SAINT® Neuromodulation System (NMS)
The SAINT® NMS utilizes a type of accelerated iTBS delivered to a personalized treatment target derived from a functional MRI scan. SAINT® was designed to optimize the individual patient response to treatment. This novel approach to TMS is accomplished by focusing on three critical aspects of the treatment that drive effect. These aspects are personalized stimulation target, total course dose of stimulation, and neurophysiologically relevant stimulation pattern.
Locations (7)
BrainHealth Solutions
Costa Mesa, California, United States
LA TMS
Los Angeles, California, United States
Integral TMS
Sunnyvale, California, United States
Acacia Research Center
Sunnyvale, California, United States
Boston Precision Neurotherapeutics
Natick, Massachusetts, United States
Fermata
Brooklyn, New York, United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, United States