NCT05147571

RNS System NAUTILUS Study

RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: NeuroPace · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.

Detailed description

NeuroPace is sponsoring the NAUTILUS Study with the RNS System for thalamic stimulation as an adjunctive therapy for the treatment of generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy. The RNS System is currently approved by the FDA for use in patients 18 years and older with hard-to-treat partial-onset seizures. The same device will be used in the NAUTILUS Study. The study is a prospective, multicenter, single-blind, randomized, sham stimulation controlled pivotal study and participants will be followed for two years after placement of the RNS System. The study will enroll a maximum of 100 participants within the United States to ensure that at least 80 participants are implanted with the RNS System. The study design includes a two-month retrospective and one-month prospective baseline. All participants will have detection enabled at the time of implant. At one month post-implant, participants will be randomized 1:1 to Active or Sham stimulation. For those randomized to the Active group, stimulation will be enabled. Participants will be blinded to their own randomization status until the 2nd GTC occurs for that individual, they completed the 9-month Effectiveness Evaluation Period (12-months post-implant), or the 60th GTC-event occurs in the group, whichever occurs first. After that, patients will be unblinded and patients in the Sham group (responsive stimulation OFF) will have responsive stimulation enabled (responsive stimulation ON).

Conditions

• Epilepsy
• Idiopathic Generalized Epilepsy
• Generalized Tonic Clonic Seizure

Interventions

Type	Name	Description
DEVICE	Responsive stimulation	The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.
DEVICE	Sham stimulation	For those in the Sham Stimulation group, the RNS System will be set to detect abnormal activity but will not have responsive stimulation enabled. Both Sham and Active groups will undergo therapy testing at each appointment in order to maintain the blind.

Timeline

• Start date: 2022-08-09
• Primary completion: 2025-04-04
• Completion: 2026-03-01
• First posted: 2021-12-07
• Last updated: 2025-07-09

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study