TMS for Depression
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three 19-min TMS treatment sessions in a single day with 1-hour rest between sessions
Follow-up
Participants are monitored for safety and effectiveness after 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
Three 19-min TMS treatment protocol delivered on the same day, with 1 hour rest between the sessions.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NeuroQore Inc.
Lead Sponsor
Makromed Inc.
Collaborator
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