SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

What this Trial Is About

Researchers are evaluating the effect of daily self-administered musical stimuli on patients with drug-resistant epilepsy who have an implanted NeuroPace Responsive Neurostimulator (RNS) device. This study is a prospective, placebo-controlled, double-blinded randomized trial conducted in a natural home environment. It builds on prior studies that showed certain music may reduce epileptiform discharges and seizures in these patients. The trial aims to see if listening to specific music can lower epileptic activity and improve mood, quality of life, and cognition. Participants will be randomly assigned to one of three groups: listening to an experimental musical piece (Music A) shown to positively affect epileptic activity, an active comparator piece similar but without known benefits (Music B), or a preferred music excerpt with some modifications (Music C). Each participant will listen daily to their assigned music on their personal device at a convenient time during the study period. Participants will be monitored over about 4 1/2 months with assessments at baseline, weeks 3-4, 9-10, and 13-14. Continuous brain activity data from the RNS device will measure epileptic episodes. Self-reported mood, quality of life, cognition, seizure frequency, and music preferences will be collected throughout the study. The team will also assess the feasibility of this at-home, self-administered auditory intervention. The overall study duration including retrospective data collection is approximately 5 1/2 months.

Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application