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

NCT07369180 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: CL-NQ-2025-01BRANY IRB File #2-02-5-1959
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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

Major Depressive Disorder

Keywords

Maor Depressive Disorder (MDD); Accelerated Treatment; 1-day Treatment

Outcome Measures

Primary Outcomes (1)

• MADRS Score

  Change in MADRS score from baseline to immediately post treatment, 24 hours, 7 days and 30 days post-treatment.

  From enrollment to final MADRS score assessment within 6 weeks.

Secondary Outcomes (1)

• PHQ-9 Score

  From enrollment to final PHQ-9 score assessment within 6 weeks.

Study Arms (2)

Active Accelerated Protocol

EXPERIMENTAL

Three 19-min TMS treatment protocol delivered on the same day, with 1 hour rest between the sessions.

Device: Active Accelerated rTMS Treatment

Sham Accelerated Protocol

SHAM COMPARATOR

Three 19-min TMS treatment protocol simulated but blocked from delivery to the target region in Cortex, on the same day, with 1 hour rest between the sessions.

Device: Sham Accelerated rTMS Treatment

Interventions

Active Accelerated rTMS Treatment DEVICE

1 Day x 3 Sessions of 19-minutes active rTMS treatment, with 60 minutes rest between sessions.

Active Accelerated Protocol

Sham Accelerated rTMS Treatment DEVICE

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.

Sham Accelerated Protocol

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Makromed Inc.: collaborator
• NeuroQore Inc.: lead

Study Sites (2)

LGTC Group

Campbell, California, 95008, United States

Location

LGTC Group

Sunnyvale, California, 94086, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Karthik Ramgopal, DO

  LGTC Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Device operators delivering the treatment regimen are also masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The subjects will be randomly and in double-blind manner (blind to investigator and participant) provided the active or sham treatment with NeuroQore's TMS system using a neuro-navigation system utilizing MRI to identify individualized target area for stimulation.

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: January 27, 2026
• Study Start: January 15, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (2)