Depressive Disorder, Treatment-ResistantNCT07876908
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
A study testing Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System in people with Depressive Disorder, Treatment-Resistant and Memory Deficits, run by BrainHealth Solutions, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant, Memory Deficits
- What is being tested?
- Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
BrainHealth Solutions Inc.
Costa Mesa, California, 92626
Melissa Perez, 949-441-5542, melyamperez@gmail.com
About this study
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
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:
Read more
- 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.
Read the detailed 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, 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.
- Being tested
- Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System
- Keywords
- Treatment-resistant depression, Memory deficits, Transcranial magnetic stimulation, Accelerated intermittent theta-burst stimulation, Older adults
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation SystemDevice
Also called SAINT, accelerated intermittent theta-burst stimulation (aiTBS), repetitive transcranial magnetic stimulation (rTMS)
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.
| Study group | Role | What they receive |
|---|---|---|
| SAINT® Neuromodulation Treatment | Experimental | Not described Receives: Device: Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 5 days after completion of SAINT stimulation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline; 5 days post-stimulation; and 3, 6, 9, and 12 months post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainHealth Solutions, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- DOR Research Accelerator
- Responsible party
- Sponsor
- Investigators
- Robert Bota, Principal investigator, BrainHealth Solutions, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876908
- Sponsor's protocol ID
- BHS-001
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07876908
- Acronym / sponsor ID
- BHS-001
- Keywords
- Treatment-resistant depression, Memory deficits, Transcranial magnetic stimulation, Accelerated intermittent theta-burst stimulation, Older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BrainHealth Solutions, Inc.University, hospital or other
- Collaborators
- DOR Research Accelerator
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAINT® Neuromodulation Treatment | Experimental | Device: Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation SystemAlso: SAINT, accelerated intermittent theta-burst stimulation (aiTBS), repetitive transcranial magnetic stimulation (rTMS)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. | Device | SAINT® Neuromodulation Treatment |
Primary outcome
Change From Baseline in Mini-Mental State Examination (MMSE) Score at 5 Days Post-Stimulation
Time frame: Baseline and 5 days after completion of SAINT 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.
3 secondary outcomes
Change in Clinical Global Impression-Improvement and Clinical Global Impression-Severity Scores
Time frame: Baseline through 12 months post-stimulation
Change From Baseline in Cognitive Function Index (CFI) Score at 12 Months
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
Time frame: Baseline; 5 days post-stimulation; and 3, 6, 9, and 12 months post-stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bota principal investigator
BrainHealth Solutions, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System in people with Depressive Disorder, Treatment-Resistant and Memory Deficits, run by BrainHealth Solutions, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Perez (949-441-5542, melyamperez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mini-Mental State Examination (MMSE) Score at 5 Days Post-Stimulation (time frame: Baseline and 5 days after completion of SAINT stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.