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ACTIVE NOT RECRUITING
NCT05819021

Open Label Optimization Study

Sponsor: Magnus Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

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