SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
An Open-Label Feasibility Trial to Assess the Efficacy of the Magnus Neuromodulation System With Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)® Technology to Treat Memory Deficits in Older Patients With Treatment-Resistant Depression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 65 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 days, 12 months
- Procedures mentioned: MRI scans, Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "The SAINT® approach uses magnetic resonance imaging (MRI)-guided targeting to personalize the stimulation location for each participant."
- "The Magnus Neuromodulation System includes a TMS stimulator, stimulation coil, neuronavigation system, and software that uses each participant's structural and functional MRI information to identify an individualized treatment target."
- "Safety monitoring includes assessment of adverse events, physical examinations, vital signs, and structured evaluations of mood symptoms and suicidal thoughts or behaviors."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether SAINT, a treatment that uses magnetic pulses to stimulate the brain, is safe and may help memory, thinking, and depression. It is for adults age 65 or older whose depression has not improved with treatment and who have memory concerns. Everyone receives 10 treatment sessions a day for 5 days, with follow-up visits for up to one year.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 65 or older, with depression that has not improved with treatment.
- Current depression symptoms, with a score of 20 or higher on the MADRS depression rating scale.
- Memory concerns reported by you or your caregiver, and a score of 10 to 28 on the MMSE memory and thinking test.
- Able to understand the study, give written consent, and complete study tests.
- An independent treating clinician says you are a good fit for 10 SAINT sessions a day for 5 days in a row.
- Had an amyloid PET scan, a Lumipulse G pTau217/Amyloid 1-42 blood test, or both during usual care within 6 months before the first study visit.
- Have confirmed health insurance coverage for rTMS/SAINT treatment for depression that has not improved with treatment.
- Willing to follow study rules, including medicine limits and study visits.
Who can't join
- Pregnant, or unable or unwilling to use acceptable birth control when required during treatment and for 30 days afterward. This applies if you or your sexual partner could become pregnant.
- Metal or a medical device in or near your head that cannot be removed and is unsafe for magnetic treatment or MRI scans; or an implanted nerve or brain stimulator in or near your head.
- A seizure disorder, except isolated childhood seizures caused by fever; a brain condition that raises seizure risk; a major abnormal MRI result; or another safety concern listed in the treatment device instructions.
- A current mental health condition other than major depression that could affect safety, such as schizophrenia, schizoaffective disorder, bipolar disorder, or PTSD; or a listed personality disorder: borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial.
- Alcohol or drug abuse or dependence in the past year, including benzodiazepines, but not caffeine or nicotine.
- High current risk of suicide, or a suicide attempt in the past 6 months.
- A serious or unstable health condition that could make the study unsafe or affect results, or a resting pulse below 40 or above 110 beats per minute at the clinic.
- A medicine or procedure that could greatly interfere with treatment, or another condition the study doctor believes would make participation unsafe or prevent you from finishing the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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: * Pregnancy * 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
Study sites (1)
CA
- BrainHealth Solutions Inc. · Costa Mesa, CA 92626Melissa Perez · Study contact · 949-241-0898 · melyamperez@gmail.comDaniela Bota · Study contact · 229-815-0230 · doctorbota@gmail.comMore trials in Costa Mesa