SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Eligible age
65+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: BrainHealth Solutions, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Costa Mesa
Source: ClinicalTrials.gov · NCT07876908 · last updated 2026-10-23