Plain-English translation of NCT04004169 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Major Depressive Disorder research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial tests the NeuroPace RNS System—a device that delivers personalized electrical stimulation to specific brain regions to help treat severe depression that hasn't improved with other treatments. Researchers first identify the best brain locations to target through temporary electrode placement, then implant a permanent device programmed to stimulate based on your unique brain activity patterns. The goal is to reduce depression symptoms by precisely targeting the brain circuits involved in your depression.
Many people with severe depression don't improve even after trying multiple medications, therapy, and other standard treatments. This trial exists to test whether a personalized brain stimulation device can help people in this situation who have limited remaining options.
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The study unfolds over three stages across approximately 18 months. In Stage 1, surgeons place temporary thin electrodes in your brain to identify which areas control your depression, then test stimulation in different locations—these electrodes are removed at the end. In Stage 2, you have a second surgery to implant the permanent RNS device, which is then programmed over 4–12 months using your unique brain activity patterns. In Stage 3, you experience the device alternately turned on and off over a full year to measure how well it works. You'll have regular clinic visits throughout, and at the end you can choose to keep the device or have it surgically removed.
AI-generated summary from trial data · Jun 17, 2026 · Not medical advice
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