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RECRUITING

NCT07876908

SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression

Sponsor: BrainHealth Solutions, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2029-02-01

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Depressive Disorder, Treatment-Resistant Memory Deficits

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.

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

Locations (1)

BrainHealth Solutions Inc.

Costa Mesa, California, United States