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NCT06357832

New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD)

A Prospective, Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS) With a New Stimulation Protocol in Subjects With Major Depression Disorder (MDD)
Brainsway·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Major Depressive Disorder
Drug/Device/Intervention
Brainsway Deep TMS System
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Brainsway
Location
Tuscaloosa,Palm Beach,Brooklyn,Abington,Seattle,South Charleston, United States of America
Timeline & enrollment
Phase
N/A
Start date
Apr 15, 2024
End date
Dec 15, 2024
Enrollment
104 participants
Primary outcome

Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group

Summary

The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the
 treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD).
 The device technology is based on the application of deep brain TMS by means of repetitive
 pulse trains at a determined frequency. The purpose of the current study is to evaluate the
 safety and effectiveness of a new investigational stimulation protocol delivered with the
 BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to
 the current standard-of-care stimulation protocol, in a randomized, controlled study.

ICD-10 classifications
Recurrent depressive disorderRecurrent depressive disorder, unspecifiedDepressive conduct disorderOther recurrent depressive disordersRecurrent depressive disorder, current episode moderate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06357832
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06357832 through Pure Global AI's free database. This phase not specified trial is sponsored by Brainsway and is currently Not yet recruiting. The study focuses on Major Depressive Disorder. Target enrollment is 104 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.