NCT07876908 SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
| NCT ID | NCT07876908 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BrainHealth Solutions, Inc. |
| Condition | Depressive Disorder, Treatment-Resistant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-10-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Robert Bota
PRINCIPAL INVESTIGATOR
BrainHealth Solutions, Inc.
Frequently Asked Questions
Who can join the NCT07876908 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Depressive Disorder, Treatment-Resistant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07876908 currently recruiting?
Yes, NCT07876908 is actively recruiting participants. Contact the research team at melyamperez@gmail.com for enrollment information.
Where is the NCT07876908 trial being conducted?
This trial is being conducted at Costa Mesa, United States.
Who is sponsoring the NCT07876908 clinical trial?
NCT07876908 is sponsored by BrainHealth Solutions, Inc.. The principal investigator is Robert Bota at BrainHealth Solutions, Inc.. The trial plans to enroll 20 participants.