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RNS System NAUTILUS Study

NCT05147571 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • Epilepsy
  • Idiopathic Generalized Epilepsy
  • Generalized Tonic Clonic Seizure

Interventions

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.

Sponsors & Collaborators

  • NeuroPace

    lead INDUSTRY

Principal Investigators

  • Martha Morrell, MD · NeuroPace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2025-04-04
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05147571 on ClinicalTrials.gov