An interventional study of Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System in Depressive Disorder, Treatment-Resistant and Memory Deficits, sponsored by BrainHealth Solutions, Inc.. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by BrainHealth Solutions, Inc. · Not applicable, Interventional, and Treatment
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:
All participants will receive SAINT® treatment. There is no placebo group.
Participants will:
Researchers will track changes in memory, mood, daily activities, and side effects.
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, thinking, and ability to perform daily activities. Transcranial magnetic stimulation is a noninvasive treatment that uses magnetic pulses to stimulate targeted areas of the brain. The SAINT® approach uses magnetic resonance imaging (MRI)-guided targeting to personalize the stimulation location for each participant. The treatment is directed to a region of the left prefrontal cortex that is involved in mood regulation and connected brain networks.
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. The study uses an accelerated intermittent theta-burst stimulation schedule. Participants receive 10 stimulation sessions per day over 5 consecutive days, for a total of 50 sessions. Each session lasts approximately 10 minutes, with approximately 50 minutes between sessions.
This study does not include a placebo or comparison group. All enrolled participants receive the study treatment. The study is designed to provide early information about whether this treatment approach can be delivered as planned in this population and to describe changes over time in memory, mood, global clinical status, and daily functioning. Findings will help inform the design of future controlled studies.
The primary efficacy assessment focuses on change in global cognitive function from before treatment to approximately 5 days after completing the treatment course. The study also evaluates depressive symptoms, clinician-rated overall improvement and severity, self-reported cognitive concerns, and ability to carry out daily activities during follow-up. Researchers will explore whether treatment effects differ according to amyloid or tau-related biomarker status from testing performed as part of participants' clinical care.
Safety monitoring includes assessment of adverse events, physical examinations, vital signs, and structured evaluations of mood symptoms and suicidal thoughts or behaviors. During the active treatment period, trained staff observe participants during stimulation sessions and assess them daily for neurological symptoms, mood elevation or destabilization, worsening depression, and other safety concerns. Hearing protection is used during all stimulation sessions. The study includes predefined rules for stopping treatment for an individual participant or pausing the study if important safety concerns arise.
The SAINT® Neuromodulation System is used clinically for TRD. In this study, researchers are evaluating whether this approach may also affect memory and thinking in older adults with depression and memory concerns.
472 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 151 are open to participants now.
This study's planned enrollment of 20 is below the median of 51 across 397 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
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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.
Also known as: SAINT, accelerated intermittent theta-burst stimulation (aiTBS), repetitive transcranial magnetic stimulation (rTMS)
Change From Baseline in Mini-Mental State Examination (MMSE) Score at 5 Days Post-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.
Time frame: Baseline and 5 days after completion of SAINT stimulation
Change in Clinical Global Impression-Improvement and Clinical Global Impression-Severity Scores
Clinician-rated global clinical status will be assessed using the Clinical Global Impression-Improvement (CGI-I) scale and Clinical Global Impression-Severity (CGI-S) scale. CGI-I rates overall improvement or worsening relative to baseline; CGI-S rates illness severity at each assessment. Scores will be summarized descriptively and evaluated longitudinally across post-baseline visits.
Time frame: Baseline through 12 months post-stimulation
Change From Baseline in Cognitive Function Index (CFI) Score at 12 Months
The Cognitive Function Index (CFI) is a questionnaire assessing perceived change in everyday cognitive functioning, including memory and other cognitive concerns. The participant responds to items regarding cognitive change compared with approximately one year earlier. Total scores range from 0 to 14, with higher scores indicating greater perceived cognitive decline or concern. Change is calculated as the 12-month score minus the baseline score; a negative change indicates improvement.
Time frame: Baseline and 12 months post-stimulation
Change From Baseline in Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI-ADL) Score Through 12 Months
The ADCS-MCI-ADL is an informant-based questionnaire that evaluates functional ability in activities of daily living relevant to individuals with mild cognitive impairment. The total score ranges from 0 to 53, with higher scores indicating greater functional independence. Change is calculated as each post-baseline score minus the baseline score; a positive change indicates improved functioning, and a negative change indicates functional decline.
Time frame: Baseline; 5 days post-stimulation; and 3, 6, 9, and 12 months post-stimulation
Durability of Cognitive, Clinical, and Functional Outcomes Following Stimulation
Descriptive evaluation of changes from baseline in cognitive, mood, clinical, and functional outcomes following SAINT® stimulation. Measures include the Mini-Mental State Examination (MMSE), Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression-Improvement (CGI-I), Clinical Global Impression-Severity (CGI-S), and Alzheimer's Disease Cooperative Study-Mild Cognitive Impairment-Activities of Daily Living (ADCS-MCI-ADL). Outcomes will be assessed longitudinally to characterize the persistence of effects after the acute treatment period.
Time frame: Baseline through 12 months following completion of stimulation; follow-up assessments at 3, 6, 9, and 12 months
Association Between Change in Depressive Symptoms and Cognitive and Functional Outcomes
Exploratory correlations between change in depressive symptom severity, measured by the Montgomery-Asberg Depression Rating Scale (MADRS), and change in cognitive and functional outcomes, measured by the MMSE, Cognitive Function Index (CFI), and ADCS-MCI-ADL. Associations will be evaluated descriptively at post-treatment visits.
Time frame: Baseline through 12 months following completion of stimulation
Differences in Cognitive, Mood, Clinical, and Functional Outcomes by Amyloid and/or Tau Biomarker Status
Exploratory descriptive comparisons of change from baseline in MMSE, MADRS, CGI-I, CGI-S, and ADCS-MCI-ADL between participants who are amyloid- and/or tau-positive and those who are amyloid- and/or tau-negative. Biomarker status will be based on amyloid PET imaging and/or Lumipulse G pTau217/Amyloid 1-42 plasma-ratio results obtained as part of clinical care.
Time frame: Baseline through 12 months following completion of stimulation
Incidence, Severity, and Relatedness of Treatment-Emergent Adverse Events
A treatment-emergent adverse event (TEAE) is any untoward medical occurrence that begins or worsens after initiation of SAINT® stimulation, regardless of relationship to treatment. All adverse events and serious adverse events will be collected and recorded. Each event will be assessed for severity using CTCAE version 5.0 and for relationship to SAINT® stimulation as definite, probable, possible, unlikely, or unrelated. Incidence will be summarized as the number and percentage of participants with one or more TEAEs, including serious adverse events.
Time frame: From first SAINT® stimulation session through 12 months post-stimulation
Plan to share: Undecided
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Depressive Disorder, Treatment-Resistant →