NCT07876908 · BrainHealth Solutions, Inc.
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
What this study is about
The goal of this clinical trial is to learn whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®), a type of transcranial magnetic stimulation (TMS), is safe and may improve memory and thinking in adults aged 65 or older with treatment-resistant depression and memory concerns. Researchers will also study whether SAINT® improves depression symptoms.
View original scientific description
The goal of this clinical trial is to learn whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®), a type of transcranial magnetic stimulation (TMS), is safe and may improve memory and thinking in adults aged 65 or older with treatment-resistant depression and memory concerns. Researchers will also study whether SAINT® improves depression symptoms. The main questions it aims to answer are: * Does SAINT® improve memory and thinking five days after treatment? * Does SAINT® improve depression symptoms and overall well-being? * Do changes in memory, mood, or daily activities last for up to one year? * What side effects or safety concerns occur during and after treatment? All participants will receive SAINT® treatment. There is no placebo group. Participants will: * Complete memory, mood, and health assessments and have an MRI scan * Receive 10 TMS sessions each day for 5 days in a row * Return for follow-up visits for up to 12 months Researchers will track changes in memory, mood, daily activities, and side effects.
Interventions
DEVICE
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System
MRI-guided, individualized accelerated intermittent theta-burst stimulation delivered with the Magnus Neuromodulation System to a personalized left dorsolateral prefrontal cortex target. Participants receive 10 stimulation sessions per day for 5 consecutive days (50 total sessions). Each 10-minute session delivers 1,800 magnetic pulses at 90% of motor threshold with depth adjustment, using 50-Hz triplet bursts at 5 Hz (2-second trains, 8-second inter-train intervals). Sessions are separated by approximately 50 minutes. Total planned exposure is 90,000 pulses. Participants wear hearing protection during stimulation.
Primary outcome measures
Change From Baseline in Mini-Mental State Examination (MMSE) Score at 5 Days Post-Stimulation
Time frame: Baseline and 5 days after completion of SAINT stimulation
The Mini-Mental State Examination (MMSE) is a clinician-administered 30-item screening measure of global cognitive function, assessing orientation, memory, attention, language, and visuoconstructional abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 65 years or older
- Diagnosis of treatment-resistant depression
- Current depressive symptoms, with a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or higher
- A memory concern reported by the participant or caregiver
- A Mini-Mental State Examination (MMSE) score between 10 and 28
- Able to understand the study, provide written informed consent, and complete study assessments
- Determined by an independent treating clinician to be an appropriate candidate for accelerated SAINT treatment, consisting of 10 treatment sessions per day for 5 consecutive days
- Completed an amyloid PET scan and/or Lumipulse G pTau217/Amyloid 1-42 blood test as part of usual medical care within 6 months before the baseline visit
- Health insurance coverage confirmed for rTMS/SAINT treatment for treatment-resistant depression
- Willing to follow study requirements, including medication restrictions and study visits
Exclusion criteria
- Unable or unwilling to use an acceptable method of birth control during the 5-day treatment period and for 30 days afterward, if of childbearing potential or sexually active with a partner of childbearing potential
- Non-removable metal or an implanted medical device in or near the head that is not safe for transcranial magnetic stimulation or magnetic resonance imaging, such as a cochlear implant, aneurysm clip, stent, or metal fragment
- An implanted neurostimulator in or near the head, such as a deep brain stimulator or vagus nerve stimulator
- History of epilepsy or a seizure disorder, except for isolated febrile seizures during childhood
- A brain condition that may increase seizure risk, such as prior brain surgery, skull defect, stroke-related brain disease, or brain tumor
- Any other contraindication to transcranial magnetic stimulation listed in the device instructions for use that the study doctor believes would increase risk
- A clinically significant abnormal magnetic resonance imaging (MRI) result
- A current psychiatric diagnosis other than major depressive disorder that could affect safe participation, including schizophrenia, schizoaffective disorder, bipolar disorder, or post-traumatic stress disorder
- A diagnosis of borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder
- Substance abuse or dependence within the past year, including alcohol or benzodiazepines, except caffeine or nicotine
- High current risk of suicide or a suicide attempt within the past 6 months
- A serious or unstable medical condition that could make participation unsafe or affect interpretation of the study results
- Resting heart rate below 40 beats per minute or above 110 beats per minute at the clinic visit
- Use of a medication or procedure that the study doctor determines may significantly interfere with transcranial magnetic stimulation treatment
- Any other condition that, in the study doctor's judgment, would make participation unsafe or prevent completion of the study requirements
Where
- Costa Mesa, California
Collaborators
DOR Research Accelerator
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2026 · Source of record for eligibility and locations