Neuromodulation System for Depression

(OLO Trial)

Not currently recruiting at 6 trial locations

Overseen By Marcia Gutierrez, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Magnus Medical

Disqualifiers: Suicide risk, Abnormal brain MRI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for Major Depressive Disorder (MDD) using the SAINT® Neuromodulation System, a type of brain stimulation therapy. The main goal is to evaluate the treatment's effectiveness in improving depression symptoms. Participants will undergo 10 sessions each day for 5 days. The trial seeks adults with MDD who haven't responded to antidepressants in their current episode and have been cleared for TMS, another form of brain stimulation therapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective therapies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SAINT® Neuromodulation System is safe for treating Major Depressive Disorder?

Research has shown that the SAINT® Neuromodulation System is generally safe and well-tolerated. This system uses a technique called repetitive transcranial magnetic stimulation (rTMS), and studies have shown positive results. Participants in these studies reported very few serious side effects.

One study specifically found that patients tolerated the SAINT system well, with no major safety issues, suggesting the treatment does not cause significant harm. However, like any treatment, minor side effects such as headaches or discomfort at the stimulation site may occur.

Overall, the safety of the SAINT system appears promising, but ongoing research continues to monitor its effects closely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAINT® Neuromodulation System (NMS) because it offers a fresh approach to treating conditions like depression. Unlike traditional treatments, which often involve medications or long-term therapy, SAINT® uses targeted brain stimulation to potentially deliver faster results. This system administers 10 short sessions per day over just five days, which could mean quicker relief for patients. Additionally, its non-invasive method of stimulating the brain sets it apart from more invasive procedures, making it a promising alternative for those seeking rapid improvement without surgery.

What evidence suggests that the SAINT® Neuromodulation System is effective for Major Depressive Disorder?

Research has shown that the SAINT® Neuromodulation System, a type of brain stimulation, effectively reduces depression symptoms. In earlier studies, more participants experienced relief compared to traditional treatments, with about 80% showing significant improvement. One study found that 18.4% of patients remained symptom-free 12 weeks after treatment. This method targets specific brain areas related to depression more accurately than older techniques. Early results suggest it could be a promising option for individuals with Major Depressive Disorder. In this trial, all participants will receive SAINT® stimulation therapy, consisting of 10 treatments per day for 5 days. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Adult males or females, 18 and older, who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Confirmed primary clinical diagnosis of major depressive disorder (MDD) without psychotic features consistent with DSM-V criteria.

No medical conditions that would preclude the safe use of TMS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3, 6, 9, 12 month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• SAINT® Neuromodulation System (NMS)

How Is the Trial Designed?

Group I: SAINT® Stimulation Experimental Treatment 1 Intervention

All participants will receive 10 treatments per day for 5 days (M-F) of SAINT® stimulation therapy.

Who Is Running the Clinical Trial?

Magnus Medical

Lead Sponsor

Trials

5

Recruited

1,100+

Citations

1. tmsjournal.org tmsjournal.org/article/S3050-5291(25)00029-7/fulltext

Assessing the Effectiveness of the SAINT® Neuromodulation ... Background: SAINT®, a functional connectivity-guided, accelerated form of intermittent theta-burst stimulation, has shown high remission rates in open-label and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25000877

Durability of clinical benefit with Stanford Neuromodulation ... Although long-term outcomes were not reported separately for each treatment arm, a subsequent analysis revealed a 12-week remission rate of 18.4 %, calculated ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/magnus-medical-tout-positive-long-term-data-for-neuromodulation-system/

Magnus Medical tout positive long-term data for ... Magnus Medical has reported positive results from a study investigating the durability of its neuromodulation system's anti-depressant effect.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03693105

The Effects of SAINT® Neuromodulation System on Explicit ... This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford ...

5. ama-assn.org ama-assn.org/public-health/behavioral-health/new-hope-depression-what-know-about-saint-therapy

New hope for depression: What to know about SAINT therapy Standard TMS treatments can improve symptoms in about 50–60% of patients, and over 30% achieve remission. But a key trial conducted with SAINT ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220177.pdf

September 1, 2022 Magnus Medical, Inc. Susan Noriega VP ... Note: The clinical performance data for the Magnus Neuromodulation System (MNS) with SAINT. Technology were obtained from a total of 70 ...

7. mearis.cms.gov mearis.cms.gov/public/publications/ntap/NTP2210157HBCW

MEARIS™ | Publication | ntap | NTP2210157HBCW - CMS The SAINT Neuromodulation System is a non-invasive repetitive transcranial magnetic stimulation (rTMS) system that identifies an individualized target and ...

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2019.19070720

Stanford Accelerated Intelligent Neuromodulation Therapy ... SAINT, an accelerated, high-dose, iTBS protocol with fcMRI-guided targeting, was well tolerated and safe. Double-blinded sham-controlled trials are needed.