Accelerated Brain Stimulation for Depression
(SAINT®SC Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byDavid Spiegel, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Magnus Medical
Must not be taking: Ketamine, ECT
Disqualifiers: Anxiety, Bipolar, Substance use, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
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.
What data supports the effectiveness of the treatment Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) for depression?
Research shows that Stanford neuromodulation therapy (SNT), previously known as SAINT, achieved a remission rate of about 90% in patients with treatment-resistant depression after just 5 days of treatment in a double-blind trial.
12345Is 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.
35678How 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.
345910Eligibility Criteria
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
Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS treatments
I am between 18 and 75 years old.
I have never had rTMS or iTBS treatments.
+14 more
Exclusion Criteria
Treatment with another investigational drug or other intervention within the study period
My treatment's intensity is more than 65% of the maximum level.
Any other condition deemed by the PI to interfere with the study or increase risk to the participant
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive SAINT neuromodulation therapy targeting the left dorsolateral prefrontal cortex for five consecutive days
1 week
5 visits (in-person)
Follow-up
Participants are monitored for changes in neural connectivity and suicidal cognition post-treatment
1 week
2 visits (in-person)
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Participant Groups
The study is testing an accelerated form of brain stimulation therapy called SAINT against sham (fake) stimulation for its effects on suicidal thoughts in patients with severe depression. The goal is to see if this intensive treatment can change how the brain processes these thoughts.
2Treatment groups
Active Control
Placebo Group
Group I: SAINT stimulationActive Control1 Intervention
Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Group II: Sham stimulationPlacebo Group1 Intervention
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) is already approved in United States for the following indications:
🇺🇸 Approved in United States as SAINT Neuromodulation System for:
- Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South Carolina (MUSC)Charleston, SC
Weill Cornell MedicineManhattan, NY
University of IowaIowa City, IA
University of Texas, AustinAustin, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Magnus MedicalLead Sponsor
Stanford UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Neuromodulation therapies and treatment-resistant depression. [2021]Patients with treatment-resistant depression (TRD) who showed partial response to pharmacological and psychotherapeutic interventions need a trial of neuromodulation therapies (NTs).
Brain stimulation for treatment-resistant depression. [2023]Depression is one of the main public health problems in the world, having a high prevalence and being considered the main cause of disability. An important portion of patients does not respond to treatment with the initial trial of conventional antidepressants in the current depressive episode of moderate to severe intensity, which characterizes treatment-resistant depression. In this context, non-invasive neuromodulation procedures use an electric current or magnetic field to modulate the central nervous system, and they represent a new option for patients with treatment-resistant depression.
Predictors of response to synchronized transcranial magnetic stimulation for major depressive disorder. [2019]Synchronized transcranial magnetic stimulation (sTMS) is a new modality to reduce symptoms of major depressive disorder (MDD). sTMS uses rotating neodymium magnets to deliver low-field stimulation matched to the individual alpha frequency (IAF). A previous multisite study showed that sTMS significantly reduced MDD symptoms in the per-protocol sample. To this end, we evaluated clinical features associated with optimal sTMS outcomes.
Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. [2022]Depression is the leading cause of disability worldwide, and half of patients with depression have treatment-resistant depression. Intermittent theta-burst stimulation (iTBS) is approved by the U.S. Food and Drug Administration for the treatment of treatment-resistant depression but is limited by suboptimal efficacy and a 6-week duration. The authors addressed these limitations by developing a neuroscience-informed accelerated iTBS protocol, Stanford neuromodulation therapy (SNT; previously referred to as Stanford accelerated intelligent neuromodulation therapy, or SAINT). This protocol was associated with a remission rate of ∼90% after 5 days of open-label treatment. Here, the authors report the results of a sham-controlled double-blind trial of SNT for treatment-resistant depression.
Double-blind, proof-of-concept (POC) trial of Low-Field Magnetic Stimulation (LFMS) augmentation of antidepressant therapy in treatment-resistant depression (TRD). [2022]Low-Field Magnetic Stimulation (LFMS) is a novel, non-invasive, sub-threshold neuromodulation technique, shown in preliminary studies to have immediate mood elevating effects in both unipolar and bipolar depressed patients.
Comparative Efficacy and Acceptability of 3 Repetitive Transcranial Magnetic Stimulation Devices for Depression: A Meta-Analysis of Randomized, Sham-Controlled Trials. [2022]Repetitive transcranial magnetic stimulation (rTMS) has been employed worldwide for therapy-resistant depression. The Food and Drug Administration has approved a number of therapeutic devices for treating major depressive disorder; however, no studies have examined the differences in efficacy and acceptability among commercially available stimulation devices. The aim of our study was to compare the efficacy and acceptability of 3 stimulation devices (NeuroStar, MagPro, and Magstim) for depressive disorders.
Safe use of repetitive transcranial magnetic stimulation in patients with implanted vagus nerve stimulators. [2021]Vagus nerve stimulation (VNS) and repetitive transcranial stimulation (rTMS) devices are FDA cleared for therapeutic use in treatment resistant depression. Since VNS systems have ferromagnetic components and large-scale safety testing has not been done, the implanted VNS device is considered a contraindication for rTMS therapy. This contraindication should not be considered absolute, as VNS components typically lie outside the electromagnetic field generated by an rTMS treatment coil. We solicited information from clinicians at several academic medical centers through an informal survey about their use of rTMS for depressed patients with implanted VNS systems, and reviewed relevant safety issues with one rTMS device manufacturer. rTMS clinical practices may use special consent procedures and take additional precautions to enhance safety in these situations. Specific recommendations are provided for minimizing risks (heating or movement of VNS components and unintended change in VNS stimulation parameters) when delivering rTMS to patients with implanted VNS systems.
The use of MR‑less MNI based neuronavigation for 10 Hz rTMS depression therapy: electrophysiological and clinical implications. [2019]Repetitive transcranial magnetic stimulation (rTMS) is a popular and effective treatment for drug resistant depression. However, there is considerable variability in clinical outcomes, in previous studies and between patients. Because of high requirements for the use of fMRI based neuronavigation, many practitioners of rTMS still choose to use a standard 5 cm rule for rTMS coil placement which leads to large variations in which brain regions are being stimulated. We decided to test the possibilities of a MNI based MR‑less neuronavigation system in rTMS depression treatment, by comparing the physiological effects and clinical outcomes of 3 distinct stimulation targets. Forty‑six patients (thirty‑three female, thirteen male) from the Republican Vilnius psychiatric hospital, all with drug resistant depressive disorder, participated in the study. All patients received high frequency (10 Hz) stimulation for 10 to 15 daily rTMS sessions. However, before the treatment they were randomly sorted into 3 groups according to stimulation target in MNI map: Group 1 received rTMS at point ‑40; 48; 35; Group 2 received rTMS at point ‑46; 45; 38; Group 3 received rTMS at point ‑38; 44; 26. Electroencephalography (EEG) recordings and clinical tests were obtained the day before the rTMS course and after the last session. There were some notable differences in physiological changes between the groups, with the largest EEG band spectral power increases found in Group 1 patients and the lowest in Group 2 patients. There was a significantly larger decrease of the Hamilton Depression Rating Scale (HAM-D) scores in the Group 3 (66.94%) compared to Group 1 (57.52%) and Group 2 (56.02%). This suggests it is possible to achieve higher clinical efficacy and less physiological impact on the brain when using different targets in a neuronavigated MNI based MR‑less rTMS system.
Accelerated transcranial magnetic stimulation for the treatment of Patients with depression: A review. [2019]Major depressive disorder is a highly prevalent and profoundly disabling psychiatric disorder with significant morbidity and mortality and it is very often resistant to antidepressants, electroconvulsive therapy and psychotherapy. Therapeutic alternatives include repetitive transcranial magnetic stimulation which may be an effective choice for treatment-resistant depression but requires prolonged treatments for at least four to six weeks. Shorter exposure to this technique might be more advantageous for certain cases. The purpose of this review is to describe and discuss studies that have evaluated the safety and efficacy of accelerated transcranial magnetic stimulation (aTMS) in the acute treatment of depression. Methods: The electronic literature (NCBI Pubmed; Science Direct) on aTMS for the treatment of depression was reviewed. In the last years, a limited number of controlled and open-label studies have been published on the subject. The majority of these studies have shown promising results with aTMS, this protocol probably being at least as safe and as efficacious as conventional rTMS (five sessions per week) in the treatment of treatment-resistant depression (TRD) with a trend for faster response rates when more intensive protocols are used (15 sessions over two days). Future well-designed sham-controlled studies with larger samples are needed to confirm the safety and efficacy of aTMS in the treatment of depression.
A Preclinical Study of Standard Versus Accelerated Transcranial Magnetic Stimulation for Depression in Adolescents. [2023]Objective: Ongoing studies are focused on adapting transcranial magnetic stimulation (TMS) for the treatment of major depressive disorder in adolescent humans. Most protocols in adolescent humans to date have delivered daily 10 Hz prefrontal stimulation with mixed results. Novel TMS dosing strategies such as accelerated TMS have recently been considered. There are knowledge gaps related to the potential clinical and pragmatic advantages of accelerated TMS. This pilot study compared the behavioral effects of a standard daily and accelerated low-intensity TMS (LI-TMS) protocol in an adolescent murine model of depression. Methods: Male adolescent Sprague Dawley rats were placed in transparent plexiglass tubes for 2.5 hours daily for 13 days as part of a study to validate the chronic restraint stress (CRS) protocol. Rats subsequently received 10 minutes of active or sham 10 Hz LI-TMS daily for 2 weeks (standard) or three times daily for 1 week (accelerated). Behavior was assessed using the elevated plus maze and forced swim test (FST). Hippocampal neurogenesis was assessed by injection of the thymidine analogue 5-ethynyl-2'-deoxyuridine at the end of LI-TMS treatment (2 weeks standard, 1 week accelerated), followed by postmortem histological analysis. Results: There were no significant differences in behavioral outcomes among animals receiving once-daily sham or active LI-TMS treatment. However, animals treated with accelerated LI-TMS demonstrated significant improvements in behavioral outcomes compared with sham treatment. Specifically, animals receiving active accelerated treatment showed greater latency to the first immobility behavior (p < 0.05; active: 130 ± 46 seconds; sham: 54 ± 39 seconds) and increased climbing behaviors (p < 0.05; active: 16 ± 5; sham: 9 ± 5) during FST. There were no changes in hippocampal neurogenesis nor any evidence of cell death in histological sections. Conclusions: An accelerated LI-TMS protocol outperformed the standard (once-daily) protocol in adolescent male animals with depression-like behaviors induced by CRS and was not accompanied by any toxicity or tolerability concerns. These preliminary findings support the speculation that novel TMS dosing strategies should be studied in adolescent humans and will inform future clinical protocols.