NeuroPace Lennox-Gastaut Syndrome Study Completes EnrollmentNeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment

NeuroPace, an epilepsy-focused medtech company, has completed enrollment and implant procedures in its feasibility investigational device exemption (IDE) study of the RNS system for the treatment of Lennox-Gastaut Syndrome (LGS) — a form of childhood-onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that can lead to injury.

"LGS is a devastating, childhood-onset seizure disorder that leads to lifelong disability,” said Tracy Dixon-Salazar, PhD, executive director of the LGS Foundation, in the press release. “85% of those with LGS continue to have seizures into adulthood despite aggressive treatment, 98% suffer from intellectual disability, and they are 12 times more likely to die prematurely than others their age. LGS families desperately need innovative treatment options to manage their seizures, and we are excited about this new study."

The RNS system is a brain-responsive neuromodulation system for treating drug-resistant focal epilepsy. Currently the only one of its kind to be approved by FDA, the closed-loop device delivers personalized, data-driven treatment “targeted to the seizure source by continuously monitoring brain activity, recognizing a patient’s unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures,” according to NeuroPace.

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The system’s ability to record ongoing EEG data enables physicians to remotely monitor patients and gain insights based on unique brain activity to optimize care. Currently, the device is approved in the US as an adjunctive therapy for patients 18 years and older with drug-resistant focal epilepsy.

The IDE study will use the RNS system to evaluate whether brain-responsive neurostimulation can be used to treat LGS. Conducted at six sites, the study enrolled a total of 20 patients 12 years and older with LGS and drug-resistant generalized onset seizures.

After completing a one-year open label period, study participants will then transition to a long-term follow-up period which will continue over 18 months.

“We are pleased to announce the advancement of our LGS IDE study and look forward to the data and learnings it provides,” said Martha Morrell, MD, chief medical officer of NeuroPace, in the release. “The results from this study could support further research of RNS therapy to improve the treatment of people with LGS. We appreciate the dedicated efforts of the investigators, research teams, participants and their families.”