Personalized Closed-Loop Brain Stimulation Using NeuroPace RNS System for Treatment-Resistant Bipolar II Depression

What this Trial Is About

Neurons are specialized cells responsible for brain functions through electrical signals, which can be disrupted in major depression. This research investigates a personalized brain stimulation approach for bipolar depression, focusing on patients whose symptoms have not improved with current treatments. The study uses the NeuroPace Responsive Neurostimulation RNS System, approved for epilepsy, to assess its potential in improving bipolar depression by altering brain activity. The study has three stages. Stage 1 involves implanting thin electrodes in brain areas linked to depression to find personalized treatment targets, with electrodes removed afterward. Stage 2 includes implanting the NeuroPace RNS System based on Stage 1 findings participants attend regular visits over 4 to 18 months to identify brain activity patterns associated with depression symptoms and pair them with stimulation. Stage 3 lasts 36 to 40 weeks, during which stimulation is turned on and off in randomized 12-week periods, including closed-loop stimulation, fixed intermittent stimulation, and sham control. Participants may continue with long-term follow-up or choose device removal after Stage 3. Participants will have multiple clinic visits for brain activity monitoring and depression assessments using scales like the Montgomery-Asberg Depression Rating Scale MADRS, Hamilton Depression Rating Scale HAMD-17, and Inventory of Depressive Symptomatology Self-Report IDS-SR. The researchers track changes in depression symptoms during treatment periods and monitor safety throughout. The study spans from initial surgery through treatment and follow-up phases, ending in 2035, with careful evaluation of personalized brain stimulation effects on bipolar depression.

Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression