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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID: NCT07369180
Run by: NeuroQore Inc.
People needed: 37
Starts: 2026-01-15
Expected to finish: 2026-03-01
Last updated by the study team: 2026-01-27

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males or females aged 22-85.
Current diagnosis of major depressive disorder according to the criteria defined in the current Diagnosis and Statistical Manual of Mental Disorders (DSM-V) without psychotic features. The diagnosis of DSM-5 criteria-defined MDD will be made by a psychiatrist in light of a comprehensive psychiatric evaluation and other available clinical data.
Drug-resistant MDD (lack of improvement on antidepressant medication in the current episode, despite adequate dose and duration and adherence to treatment).
MADRS score > 20 at baseline and immediately prior to the day of treatment.
Agrees to adhere to the study treatment and follow-up schedule.
Evidence of no change in AD medications or psychotherapy from 4 weeks prior to enrollment and participant's agreement not to request such changes through 2 weeks after study regimen treatment.
Fluent in English.

You may not qualify if…

Any medical conditions that would preclude the use of rTMS to treat depression.
Any conditions that would prevent the ability to undergo MRI testing.
Pregnancy as determined by serum/urine pregnancy test
History of epilepsy, seizure(s), or a seizure disorder as determined by the principal investigator based on a medical history obtained from the patient and/or others authorized to provide such history, combined with a brief screening instrument.
Active substance abuse
Diagnosis of bipolar or psychotic disorder
Considered to be at moderate-high risk of suicide according to the C-SSRS assessment (i.e., Answers YES to Question 3 and NO to Question 6; or answers YES to Question 4, 5, or 6)
As determined by the Principal Investigator, subjects with cognitive impairment according to either the medical history obtained from the patient and/or a reliable secondary source, or the results of the Montreal Cognitive Assessment (MoCA) performed during screening.

Where it is running

LGTC Group — Campbell, California, United States
LGTC Group — Sunnyvale, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.