Accelerated Brain Stimulation for Depression
(SAINT®SC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a magnetic pulse therapy on adults with severe depression and suicidal thoughts. The therapy targets a specific brain area to change brain communication, aiming to reduce suicidal thoughts and improve mood.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is accelerated brain stimulation for depression safe for humans?
Repetitive transcranial magnetic stimulation (rTMS), a similar technique, is generally considered safe for treating depression, even in patients with implanted devices, though special precautions may be needed. Safety data for other forms of magnetic stimulation, like Low-Field Magnetic Stimulation (LFMS), also suggest it is non-invasive and safe, with no major safety concerns reported in preliminary studies.12345
How is the SAINT treatment different from other treatments for depression?
The SAINT treatment is unique because it uses an accelerated protocol of intermittent theta-burst stimulation (iTBS), which significantly reduces the treatment duration to just 5 days and achieves a high remission rate of about 90% for treatment-resistant depression, compared to the traditional 6-week course of iTBS.12678
What data supports the effectiveness of the treatment Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) for depression?
Who Is on the Research Team?
Brandon Bentzley, MD
Principal Investigator
Magnus Medical
Are You a Good Fit for This Trial?
Adults aged 18-75 with major depressive disorder or bipolar II experiencing a current major depressive episode, who have not responded well to previous treatments. Participants must be in good health, avoid pregnancy, caffeine, alcohol and tobacco during the trial. They should also be able to understand English and provide consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SAINT neuromodulation therapy targeting the left dorsolateral prefrontal cortex for five consecutive days
Follow-up
Participants are monitored for changes in neural connectivity and suicidal cognition post-treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Sham Stimulation
- Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Magnus Medical
Lead Sponsor
Stanford University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator