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
BrainHealth Solutions, Inc.
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.
Description
This is a prospective, open-label, single-arm feasibility study of the Magnus Neuromodulation System using Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) in older adults with treatment-resistant depression (TRD) and memory concerns. The study will evaluate the feasibility, safety, tolerability, and preliminary clinical effects of an accelerated, individualized transcranial magnetic stimulation (TMS) treatment course. TRD is associated with ongoing depressive symptoms despite prior antidepressant treatment. In older adults, depression may occur with concerns about memory, th…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
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 d…
Interventions
- DeviceStanford 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.
Location
- BrainHealth Solutions Inc.Costa Mesa, California