Phase 1 Study of Deep Brain Stimulation of the Deep Cerebellar Nuclei Using Medtronic Percept RC System for Treating Refractory Tremor

What this Trial Is About

Researchers are evaluating the safety and feasibility of electrical stimulation targeting the deep cerebellar nuclei using the Medtronic Percept RC Deep Brain Stimulation System for patients with refractory tremor. The study focuses on individuals who have either failed prior treatments such as Vim DBS or HIFU thalamotomy, or those not suitable for these treatments due to cerebellar outflow or MS-related tremor. Eligible participants include those diagnosed with essential tremor, cerebellar outflow tremor, or MS-related tremor with a history of tremor lasting at least three years and refractory to medical management. Participants will receive deep brain stimulation of the deep cerebellar nuclei using the Medtronic Percept RC DBS System. This device delivers electrical impulses to specific brain areas to potentially address tremor symptoms. The study is a single-group, phase 1 trial where all participants receive this intervention. The treatment and monitoring period extends from the time of device implantation through an average of 17 months. During the study, participants will be monitored for safety and treatment-related adverse events from DBS implant surgery through study completion. Researchers will assess tremor severity using the Fahn Tolosa Marin Tremor Rating Scale, record DBS-evoked potentials, and measure tremor-related brain oscillations in the 4-8 Hz range. Participants will undergo assessments over approximately 17 months, with evaluations including clinical scales and device-related measurements to understand treatment effects and safety.

Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor