TMS for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new schedule for Transcranial Magnetic Stimulation (TMS) to treat Major Depressive Disorder (MDD). Typically, TMS involves 30 sessions over six weeks, but this study explores three sessions in one day. The trial compares the real treatment to a sham (fake) version to determine if the new schedule is safe and effective. It targets adults aged 22-85 who haven't responded to antidepressant medications in their current depressive episode. Participants must be fluent in English and have no recent changes in their depression treatments. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those seeking alternatives to traditional methods.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not change your antidepressant medications or psychotherapy from 4 weeks before joining the study until 2 weeks after the treatment ends.
What prior data suggests that this TMS protocol is safe for treating depression?
Research has shown that Transcranial Magnetic Stimulation (TMS) is generally well-tolerated. Studies have found that both monophasic and biphasic TMS can reduce depression symptoms without major side effects, indicating the treatment's safety for most people.
This study uses the NeuroQore Square TMS system with a faster schedule. Participants will have three sessions in one day with breaks in between, instead of one session per day. Although this method is new, it employs the same TMS treatment that the FDA has approved for depression, providing some reassurance about its safety.
Prospective participants should know that the study aims to determine if this faster method is both safe and effective. The researchers aim to ensure the treatment remains comfortable, even with the quicker schedule.12345Why are researchers excited about this trial?
Most treatments for depression, like antidepressants or psychotherapy, can take weeks to show results. But researchers are excited about the NeuroQore Square TMS because it offers a new, accelerated approach. This treatment uses Transcranial Magnetic Stimulation (TMS), which is non-invasive and targets specific brain regions involved in mood regulation. Unlike traditional TMS, this protocol is designed to deliver three sessions in a single day with breaks in between, potentially speeding up the response time. This could mean faster relief for people with depression, offering a promising alternative to slower-acting treatments.
What evidence suggests that the NeuroQore Square TMS system is effective for treating Major Depressive Disorder?
Research has shown that Transcranial Magnetic Stimulation (TMS) effectively treats Major Depressive Disorder (MDD). Studies have found that TMS can greatly reduce depression symptoms. In this trial, participants will receive either the Active Accelerated Protocol or the Sham Accelerated Protocol. The NeuroQore Square TMS system, used in the Active Accelerated Protocol, employs a special rectangular pattern for its magnetic pulses. Early results suggest this method works as well as standard TMS treatments. This system combines the usual sessions into one day, potentially providing faster relief.14678
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
Citations
NQ Square TMS for MDD 1Dx3S Adults Multi-site Sham- ...
This multi-site sham-controlled double-blinded randomized study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore Square TMS ...
Comparison of clinical outcomes with two Transcranial ...
Transcranial magnetic stimulation (TMS) is an effective treatment for major depressive disorder (MDD). The rest time between pulse trains is the inter-train ...
The Effectiveness of Transcranial Magnetic Stimulation in ...
In both groups, TMS resulted in marked improvement in depressive symptom severity. The magnitude of benefit, trajectory of symptomatic improvement, and ...
Rectangular Repetitive Transcranial Magnetic Monophasic ...
As such, the objective of this pilot study was to provide a comparative evalua- tion of the efficacy, safety, and tolerability of six weeks of mono- phasic ...
TMS for Depression · Info for Participants
The trial tests an accelerated form of TMS therapy using NeuroQore Square's system to treat MDD. Participants will receive three 19-minute ...
Rectangular Repetitive Transcranial Magnetic Monophasic ...
Both monophasic and biphasic rTMS protocols significantly reduced depressive symptoms in patients with TRD without any significant side effects.
NeuroQore rTMS (Monophasic vs. Biphasic) for Major ...
Approximately half of major depressive patients seek out treatment for their illness and only 20% of those individuals report their treatment as satisfactory.
Utilization and outcomes of transcranial magnetic stimulation ...
This study analyzed data from a large, multi-site psychiatric practice to evaluate utilization and outcomes of TMS as well as usual care (UC) for patients with ...
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