TMS for Depression

Enrolling by invitation at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NeuroQore Inc.
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

KR

Karthik Ramgopal, DO

Principal Investigator

LGTC Group

Are You a Good Fit for This Trial?

Adults aged 22-85 with Major Depressive Disorder (MDD) who haven't improved on antidepressants can join this trial. They must have a certain level of depression severity, not change their meds or therapy for specific periods before and after the study, and be fluent in English.

Inclusion Criteria

I haven't changed my Alzheimer's medications or therapy in the last 4 weeks and agree not to change them during the study.
I am between 22 and 85 years old.
I have been diagnosed with major depression without psychosis by a psychiatrist.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive three 19-min TMS treatment sessions in a single day with 1-hour rest between sessions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
3 visits (in-person) at 24 hours, 7 days, and 30 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • NeuroQore Square TMS

Trial Overview

The trial tests an accelerated form of TMS therapy using NeuroQore Square's system to treat MDD. Participants will receive three 19-minute treatments in one day instead of daily sessions over six weeks, compared against a sham (placebo-like) treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Accelerated ProtocolExperimental Treatment1 Intervention
Group II: Sham Accelerated ProtocolPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NeuroQore Inc.

Lead Sponsor

Trials
3
Recruited
90+

Makromed Inc.

Collaborator