BrainHealth Solutions in Costa Mesa is conducting a research study of SAINT® brain stimulation and memory in older adults whose depression has not improved enough with antidepressant medications.
This research study (Protocol BHS-001) is looking at the safety, tolerability, and possible effects of the Magnus Neuromodulation System with SAINT® technology on memory and thinking in adults 65 and older with treatment-resistant depression. Up to 20 people will take part at our Costa Mesa clinic.
SAINT® is a form of transcranial magnetic stimulation (TMS) that uses magnetic pulses to stimulate an area of the brain involved in mood. An MRI scan is used to plan a personalized treatment location.
Other requirements apply. For example, people with a history of seizures or with metal implants in or near the head may not be able to take part. The study team will review all requirements with you.
Please note: SAINT® is cleared by the FDA for the treatment of depression. Its use in this study to look at memory and thinking is investigational. This study does not involve any study medication. We do not know whether it will help, and the study cannot promise any benefit.
Over 1 to 2 days: a consent discussion, review of your health history, an MRI scan, and mood and memory assessments.
5 weekdays in a row, about 10 hours a day in the clinic: 10 sessions of 10 minutes, each followed by a 50-minute rest. You may rest, walk, or bring food and drinks.
Visits of about 30 minutes at 5 days and at 3, 6, 9, and 12 months after treatment, in the clinic or by secure video.
No. SAINT® is a non-medication treatment, and this study does not involve taking any study medication. The study team will review your current medications with you, and you will be asked to keep them stable during the treatment week.
No. You will not be paid to take part in this study.
The most common side effects of TMS are headache, scalp discomfort, dizziness, and tiredness. Seizures are a rare risk. Treatment can be loud, so earplugs are required. The study team will explain all risks before you decide.
No. Taking part is voluntary, and you may stop at any time. Your decision will not affect your care at BrainHealth Solutions or with your own doctor.
Yes. A family member or caregiver is welcome to call with you or on your behalf to learn more. The person taking part will need to decide for themselves and provide written consent.
Physicians may share study information with patients or, with the patient’s permission, send a referral.
Download referral formMon to Fri, 8:30 AM to 5:00 PM
[email protected]
3151 Airway Ave, Bldg A & R, Costa Mesa, CA 92626
Principal Investigator: Robert G. Bota, MD, MSG, DFAPA
Please do not include health information in this form. A member of the study team will call you to explain the study and answer your questions. Submitting this form does not sign you up for the study.
