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RNS System LGS Feasibility Study

StatusActive, Not Recruiting
PhasePhase 2
SponsorNeuroPace
Started2022-10-04
View on ClinicalTrials.gov ↗
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.

Amendment history 1 change detected by DataLookout

2026-09-16
Primary completion pushed: 2026-05-31 → 2026-11-30
Trial Details
NCT Number NCT05339126
Lead Sponsor NeuroPace
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), University of Florida
Conditions Epilepsy, Lennox Gastaut Syndrome, Lennox-Gastaut Syndrome, Intractable, Seizures, Seizures, Generalized
Enrollment 24 participants
Start Date 2022-10-04
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15