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New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD) - Trial NCT06357832

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT06357832
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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)

Study Focus

Major Depressive Disorder

Brainsway Deep TMS System

Interventional

device

Sponsor & Location

Brainsway

Tuscaloosa,Palm Beach,Brooklyn,Abington,Seattle,South Charleston, United States of America

Timeline & Enrollment

N/A

Apr 15, 2024

Dec 15, 2024

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 disorder
Recurrent depressive disorder, unspecified
Depressive conduct disorder
Other recurrent depressive disorders
Recurrent depressive disorder, current episode moderate

Data Source

ClinicalTrials.gov

NCT06357832

Device Trial