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

NCT07369180 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Makromed Inc.

    collaborator UNKNOWN

  • NeuroQore Inc.

    lead INDUSTRY

Principal Investigators

  • Karthik Ramgopal, DO · LGTC Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369180 on ClinicalTrials.gov