💬In plain words
What the trial is, and whether it could suit you
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 f
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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