SAINT therapy for memory issues in older adults with treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm feasibility study using the Magnus Neuromodulation System to deliver SAINT® with MRI-guided targeting in older adults. Participants undergo 10 TMS sessions daily for 5 consecutive days (total 50 sessions) and are followed for up to 12 months to monitor memory, mood, daily functioning, safety, and tolerability. Researchers aim to determine feasibility, safety, and preliminary clinical effects on memory, thinking, depression symptoms, and overall well-being. No placebo control is used; all participants receive SAINT® treatment. Assessments include memory, mood, health measures, and MRI scans to guide treatment targets.

Why it matters

Who can join: the full rules

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

Where it's running

• BrainHealth Solutions Inc.
  Costa Mesa, California, United States Recruiting

Study contacts

• Principal investigator: Robert Bota — BrainHealth Solutions, Inc.
• Study coordinator: Melissa Perez
• Email: melyamperez@gmail.com
• Phone: 949-441-5542

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.