Brain Stimulation implant for severe depression that hasn't improved with medications

Plain-English translation of NCT04124341 on ClinicalTrials.gov ↗ · Source last updated January 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study is testing Prefrontal Cortical Stimulation (PCS), a surgically implanted device that delivers electrical stimulation to a specific area of the brain to treat severe depression. You would receive the implant if you have struggled with depression for at least 2 years and haven't found relief from four or more different antidepressant medications. The treatment aims to reduce depression symptoms in ways that traditional medications alone have not been able to achieve.

Many people with severe depression do not respond adequately to standard antidepressant medications, leaving them with limited options for treatment. This trial exists to test whether direct brain stimulation using this implanted device can provide meaningful and lasting relief for these patients.

Do you qualify?

You likely qualify if…

you have had a diagnosis of depression for at least 2 years
you have tried four or more different antidepressant medications from different medication classes without adequate improvement
you have either received electroconvulsive therapy (ECT) or decided it was not right for you
you have a depression severity score of 20 or higher on a standard assessment scale
you are able to undergo an MRI scan and complete brain imaging and electrical monitoring sessions
you are enrolled in a Medicare health insurance program

You likely don't qualify if…

you have had a suicide attempt within the past 12 months that required medical treatment, or two or more suicide attempts in the past year
you are at acute risk of suicide right now or have made a specific suicide plan in the past 30 days
you have a history of schizophrenia, schizoaffective disorder, psychotic disorder, or psychotic depression
you have dementia or significant cognitive decline (Mini-Mental State Exam score of 23 or lower)
you are unable to have an MRI due to medical implants or other contraindications

What participation looks like

You would first complete a 2-week baseline period with medical exams, blood work, and brain imaging to confirm you are eligible. If eligible, you would be hospitalized for at least 3 days for surgery to implant the device. Over the next 19 weeks, you would attend 10 follow-up visits where doctors assess your depression and adjust the stimulation settings while monitoring your brain activity. After that, you would continue monthly visits for 7 months, and then quarterly visits (either in-person or by video) for up to 4 years to track your progress and ensure the device is working well.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Brain Stimulation implant for severe depression that hasn't improved with medications

What is this trial?

Do you qualify?

What participation looks like

Trial locations