Plain-English translation of NCT07127913 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · 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.
This trial is testing a personalized closed-loop brain stimulation system called the NeuroPace RNS® System for people with bipolar II disorder whose depression hasn't improved with medication. The device learns your individual brain patterns and delivers stimulation automatically when it detects activity linked to depression. The study has three stages: first, doctors identify the best brain locations to stimulate; then they implant the permanent device and fine-tune it to your unique patterns; finally, they test whether the treatment actually reduces your depression symptoms.
Many people with bipolar depression don't get relief from standard medications or other treatments like electroconvulsive therapy, leaving them struggling with ongoing symptoms. This trial is exploring whether a personalized, smart brain stimulation device could offer hope for those who have run out of other options.
You likely qualify if…
You likely don't qualify if…
If you qualify, you'll undergo three stages over roughly 9–12 months. In Stage 1, surgeons will implant temporary electrodes in your brain to identify the best treatment spots, then remove them after testing. In Stage 2, you'll have a second surgery to implant the permanent NeuroPace RNS® System, and over 4–18 months you'll have regular clinic visits where doctors program it to match your unique brain patterns. In Stage 3, you'll spend 36–40 weeks testing whether the device works by having it turned on and off in different patterns while researchers track your depression symptoms.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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