Recruiting

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

Sponsor:

BrainHealth Solutions, Inc.

Code:

NCT07876908

Conditions

Depressive Disorder, Treatment-Resistant

Memory Deficits

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®) with the Magnus Neuromodulation System

Study Details

Brief 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.

Conditions

Depressive Disorder, Treatment-Resistant

Memory Deficits

Study ID

NCT07876908

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAINT® Neuromodulation Treatment

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Melissa Perez

949-241-0898 melyamperez@gmail.com

Daniela Bota

229-815-0230 doctorbota@gmail.com

Locations

BrainHealth Solutions Inc.

Recruiting

Costa Mesa, California, United States, 92626

Contacts

Melissa Perez

949-241-0898 melyamperez@gmail.com

Daniela Bota

229-815-0230 doctorbota@gmail.com

More Information

Sponsor

BrainHealth Solutions, Inc.

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

Treatment-resistant depression
Memory deficits
Transcranial magnetic stimulation
Accelerated intermittent theta-burst stimulation
Older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by BrainHealth Solutions, Inc. on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.