NCT07369180

NQ Square TMS for MDD 1Dx3S Adults Multi-site Sham-controlled Protocol

Safety and Efficacy of an Accelerated, Rectangular Waveform rTMS Protocol in Treatment of Adults With Major Depressive Disorder.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: NeuroQore Inc. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions. The goal of this multi-site sham-controlled double-blinded randomized clinical trial is to evaluate the safety and effectiveness of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder. The accelerated protocol of this study will involve the same currently FDA-cleared 19-min treatment session offered three times in a single day, with no additional treatment sessions.

Detailed description

Study Description: This multi-site sham-controlled double-blinded randomized study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder. Currently cleared protocol with the FDA (the Standard of Care Protocol) is one 19-min treatment session a day for 5 days/week for 6 weeks. The accelerated protocol will involve the same 19-min treatment session offered three times in a single day, with no additional treatment sessions. Primary Objectives: 1. To assess the efficacy of the NeuroQore Square TMS system, with accelerated delivery, in the treatment of adults with major depressive disorder as measured by a change in MADRS score 24 hours, 7 days and 30 days after the treatment end. 2. To compare the safety profile of the accelerated delivery protocol to the historical safety profile of the Standard of Care protocol. End Points: Primary * Change in MADRS score from baseline to 24 hours, 7 days and 24 days post treatment. * Number and type of adverse events. Secondary * Change in PHQ-9 score from baseline to 24 hours, 7 days and 24 days post treatment. Study Population: Men and women 22-85 with major depressive disorder that have failed one medication in the current episode. Its demographics will reflect variations in race, ethnicity, residence status (urban, suburban, rural), and socioeconomic status (education, profession). Study Intervention: NeuroQore TMS System includes (1) a pulse generator, (2) a magnetic coil, (3) a coil cooler, and (4) a chair with a headpiece. It has been cleared for clinical use (K232688) by the FDA for the treatment of Major Depressive Disorder (MDD) using a 19-min Standard of Care protocol. Treatment during this study will be administered according to this protocol and following the instructions in the device user manual. Personalized stimulation targets will be produced from participants' structural MRI via the proprietary targeting generation component of the NeuroQore TMS system. Only personnel trained and certified by NeuroQore will be permitted to administer treatment. All session and device information will be captured on appropriate data collection forms. Study Duration: The study is anticipated to last up to 3 months including enrollment and follow-up. Individual participant duration in the study will be 1 day of treatment, 24- hour, 7-day and 30-day follow-up.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Active Accelerated rTMS Treatment	1 Day x 3 Sessions of 19-minutes active rTMS treatment, with 60 minutes rest between sessions.
DEVICE	Sham Accelerated rTMS Treatment	1 Day x 3 Sessions of 19-minutes sham rTMS treatment, with 60 minutes rest between sessions. It simulates the treatment regimen but blocks the treatment from reaching the target in Cortex.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study