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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Brainsway · Industry
• Sex: All
• Age: 22 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Brainsway Deep TMS System	The BrainsWay Deep 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.

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-02-26
• Completion: 2026-03-05
• First posted: 2024-04-10
• Last updated: 2026-03-10

Locations

9 sites across 3 countries: United States, India, Israel

Regulatory

• FDA-regulated device study