Adjusting Deep Brain Stimulation Settings to Improve Care for Adults with Medically Refractory Epilepsy

What this Trial Is About

Researchers are studying deep brain stimulation DBS in patients with medically refractory epilepsy who are not candidates for surgical removal of brain tissue. This early phase 1 trial aims to develop a personalized platform for optimizing DBS settings based on power spectral density PSD measures to potentially improve seizure control. Although DBS has been shown to reduce seizures, achieving complete seizure freedom remains rare, motivating this research. Participants already implanted with a DBS device will be randomly assigned to one of three groups, each receiving different orders of stimulation settings labeled PS and OS. Each participant will experience all three stimulation orders in varying sequences during the study. This approach allows researchers to compare the effects of different DBS parameter schedules on brain activity. During the one-year study, participants will be monitored for changes in brain broadband power and specific low-frequency power under different DBS settings. Researchers will also track seizure occurrences and assess cognitive function using the Montreal Cognitive Assessment MoCA and quality of life with an epilepsy-specific questionnaire QOLIE-10P. The study includes double masking to reduce bias and will assess outcomes at one year from baseline.

Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy