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

Part of paid clinical trials in Campbell, California.

Sponsor
NeuroQore Inc.
Study ID
NCT07369180
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Accelerated rTMS Treatment — DEVICE
    1 Day x 3 Sessions of 19-minutes active rTMS treatment, with 60 minutes rest between sessions.
  • 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.

Study Details

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 Dates

Start date
Jan 15, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
37 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Accelerated Protocol
    Three 19-min TMS treatment protocol delivered on the same day, with 1 hour rest between the sessions.
  • Sham Comparator: Sham Accelerated Protocol
    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.

Primary Outcome Measure

MADRS Score [ Time Frame: From enrollment to final MADRS score assessment within 6 weeks. ]

Locations (2)

FacilityCityStateZIPSite coordinators
LGTC GroupCampbellCalifornia95008-
LGTC GroupSunnyvaleCalifornia94086-

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