SAINT® Therapy for Treatment-Resistant Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called SAINT® to determine if it can improve memory and thinking in adults aged 65 or older with treatment-resistant depression and memory concerns. Researchers aim to assess whether SAINT® can also enhance depression symptoms and overall well-being. Participants will undergo 10 sessions of transcranial magnetic stimulation (TMS) therapy each day for five days. The trial seeks individuals with persistent depression unresponsive to other treatments and who experience memory issues.
As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that you must follow medication restrictions. The study doctor will decide if any of your medications might interfere with the treatment.
What prior data suggests that SAINT® Therapy is safe for treatment-resistant depression?
Research has shown that Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) is safe and well-tolerated for treating depression. This therapy uses transcranial magnetic stimulation (TMS), which patients have found comfortable. In one study, nearly 80% of participants with severe depression experienced a significant reduction in symptoms after just five days of SAINT® treatment.
Moreover, a double-blind study confirmed SAINT®'s safety, as participants reported no major safety concerns or severe side effects. As a noninvasive procedure, SAINT® does not require surgery or a hospital stay, enhancing its safety profile.
In summary, current studies suggest that SAINT® is a safe option for individuals with depression unresponsive to other treatments. It works quickly and is generally well-tolerated with minimal side effects.12345Why are researchers excited about this trial?
Researchers are excited about SAINT® Therapy for treatment-resistant depression because it offers a faster and potentially more effective approach compared to current options. While most treatments like antidepressants and traditional transcranial magnetic stimulation (TMS) can take weeks to show results, SAINT® uses accelerated neuromodulation to potentially deliver improvements in just days. This therapy targets the brain's circuits more intensively and rapidly, which could offer hope for those who haven't responded to other treatments.
What evidence suggests that SAINT® Therapy is effective for treatment-resistant depression?
Research has shown that SAINT® therapy, which participants in this trial will receive, could help people with depression unresponsive to other treatments. Studies found that 79% to 90% of participants experienced remission, significantly improving their depression symptoms. In some studies, depression scores dropped by an average of 52.5% after treatment. This therapy uses a special kind of transcranial magnetic stimulation (TMS), a non-invasive method to stimulate the brain. Early results suggest that SAINT® might be a strong option for those who haven't found relief with other treatments.678910
Who Is on the Research Team?
Robert Bota
Principal Investigator
BrainHealth Solutions, Inc.
Are You a Good Fit for This Trial?
This trial is for adults aged 65 or older who have depression that hasn't improved with standard treatments and are experiencing memory problems. Participants should be able to attend daily sessions and follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10 TMS sessions each day for 5 consecutive days using the SAINT® Neuromodulation System
Follow-up
Participants are monitored for safety and effectiveness, with assessments of memory, mood, and daily activities
What Are the Treatments Tested in This Trial?
Interventions
- Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®)
Trial Overview
The study tests SAINT® therapy, a form of transcranial magnetic stimulation (TMS), using the Magnus Neuromodulation System. All participants receive the treatment—10 TMS sessions per day over five days—with follow-ups for up to one year.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
BrainHealth Solutions, Inc.
Lead Sponsor
DOR Research Accelerator
Collaborator
Citations
1.
stanfordhealthcare.org
stanfordhealthcare.org/medical-clinics/stanford-accelerated-intelligent-neuromodulation-therapy-in-palo-alto.htmlStanford Accelerated Intelligent Neuromodulation Therapy ...
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) is a noninvasive outpatient procedure that helps people with treatment-resistant depression.
Stanford Accelerated Intelligent Neuromodulation Therapy ...
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment- ...
News - Brain Stimulation Lab - Stanford University
Remarkable Improvement Rate Reported in Patients Who Received SAINT, an Experimental Non-Invasive Brain-Stimulation Treatment for Resistant Depression.
4.
hawaiineuroscience.com
hawaiineuroscience.com/abstract/saint-stanford-accelerated-intelligent-neuromodulation-therapy-as-a-personalized-continuation-therapy-for-depression/31. SAINT (Stanford Accelerated Intelligent ...
SAINT has shown 79-90% remission rates for TRD in randomized controlled and open-label trials, respectively. MADRS score across all time points was 8.0, ...
Stanford neuromodulation therapy (SNT): a double-blinded ...
This protocol was associated with ∼90% remission after 5 days of open-label treatment. Mean percent reduction in MADRS score 4-weeks after treatment was 52.5% ...
6.
stanfordhealthcare.org
stanfordhealthcare.org/medical-treatments/s/stanford-accelerated-intelligent-neuromodulation-therapy.htmlStanford Accelerated Intelligent Neuromodulation Therapy ...
SAINT is a safe, noninvasive outpatient procedure for depression. Stanford Medicine researchers developed this treatment, which quickly improves symptoms.
Stanford Accelerated Intelligent Neuromodulation Therapy for ...
SAINT, an accelerated, high-dose, iTBS protocol with fcMRI-guided targeting, was well tolerated and safe. Double-blinded sham-controlled ...
For Patients - Brain Stimulation Lab - Stanford University
This study evaluates the safety and feasibility of using real-time functional MRI neurofeedback techniques to treat major depressive disorder. Leveraging a high ...
Stanford Accelerated Intelligent Neuromodulation Therapy ...
Open-label trials have found a striking ∼90% remission rate from depression in severely treatment-resistant patients. Herein, we report the results of a sham- ...
Durability of clinical benefit with Stanford Neuromodulation ...
We note a range of approximately 15–30 % of participants who receive rTMS for depression will continue to be in remission 12 weeks following treatment. 4.2.
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