RNS System NAUTILUS Study

Completed · Not applicable · Has a placebo group

Conditions studied: Epilepsy, Idiopathic Generalized Epilepsy, Generalized Tonic Clonic Seizure

In brief

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.

Key facts

Study ID

NCT05147571

Run by

NeuroPace

People needed

100

Starts

2022-08-09

Expected to finish

2026-03-31

Last updated by the study team

2026-06-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is age 12 and older.
• Participant is male or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).
• Participant failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
• Participant is able to maintain an electronic diary alone or with the assistance of a competent individual.
• Participant is able to attend clinic appointments in accordance with the study schedule.
• Participant or parent(s) or legal representative have signed an IRB approved written informed consent/assent. The informed consent form or specific assent form, where required, will be signed and dated by minors.
• Participant is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
• In the investigator's opinion, participant is able to tolerate a neurosurgical procedure.
• Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures, with or without myoclonic or absence seizures, consistent with the International League against Epilepsy Revised Classification of Seizures (2017).
• Participant has had 2 or more generalized tonic-clonic seizures during the two month retrospective baseline.
• Participant has had a routine electroencephalogram (EEG) within 2 years prior to enrollment with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history.
• Participant has been on a stable antiseizure medication (ASM) regimen during the two month retrospective baseline and is willing to remain on a stable ASM regimen during the prospective Baseline and throughout the Effectiveness Evaluation Period, if medically possible; rescue benzodiazepine medications for acute seizure clusters are permitted.
• Participant has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to enrollment that ruled out a progressive cause of epilepsy or an abnormality likely to be associated with focal-onset seizures.
• Participant does not have a vagus nerve stimulator (VNS, LivaNova) or Participant's VNS is OFF during the two month retrospective baseline and participant is willing to keep the VNS off during the study.

You may not qualify if…

• Participant is pregnant.
• Participant is participating in a therapeutic investigational drug or other device study.
• Participant is implanted with an electronic medical device that delivers electrical energy to the brain.
• Participant requires procedures that are contraindicated based on current RNS System labeling.
• Participant has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Participants with post-ictal psychiatric symptoms need not be excluded.
• In the opinion of the investigator, the participant has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
• Participant has a history of partial-onset seizures or EEG findings within the past 2 years indicative of partial-onset or symptomatic generalized abnormalities.
• Participant has been diagnosed with psychogenic or non-epileptic seizures in the preceding year.
• Participant has experienced unprovoked status epilepticus in the preceding year.
• Participant is taking any anticoagulants.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• University of Colorado — Aurora, Colorado, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Indiana University Health — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Spectrum Health Butterworth Hospital — Grand Rapids, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Mary Hitchcock Memorial Hospital (Dartmouth) — Lebanon, New Hampshire, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• New York University Langone — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah Healthcare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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