SAINT magnetic brain stimulation for memory problems in older adults with hard-to-treat depression

Trial details

Who runs it

BrainHealth Solutions, Inc.

Trial code

NCT07876908

Record updated

28 October 2026

Original 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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; A brain condition that may increase seizure risk, such as prior brain surgery, skull defect, stroke-related brain disease, or brain tumor; Use of a medication or procedure that the study doctor determines may significantly interfere with transcranial magnetic stimulation treatment; History of epilepsy or a seizure disorder, except for isolated febrile seizures during childhood; 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; 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; Any other condition that, in the study doctor's judgment, would make participation unsafe or prevent completion of the study requirements; 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; An implanted neurostimulator in or near the head, such as a deep brain stimulator or vagus nerve stimulator; 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; 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.

ClinicalTrials.gov NCT07876908