RNS System NAUTILUS Study (NAUTILUS)

V
Vicenta Salanova, MD

Primary Investigator

Not Recruiting
12 years or above
All
Phase 3
100 participants needed
1 Location

Brief description of study

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

Detailed description of study

NeuroPace is sponsoring the NAUTILUS Study with the RNS System for thalamic stimulation as andjunctive therapy for the treatment of generalized seizures in individuals 12 years of ageder who have drug-resistant idiopathic generalized epilepsy. The RNS System is currentlyved by the FDA for use in patients 18 years and older with hard-to-treat partial-onsetzures. The same device will be used in the NAUTILUS Study.
The study is a prospective, multicenter, single-blind, randomized, sham stimulationd pivotal study and participants will be followed for two years after placement ofhe RNS System. The study will enroll a maximum of 100 participants within the United Statesure that at least 80 participants are implanted with the RNS System.
The study design includes a two-month retrospective and one-month prospective baseline. Allwill have detection enabled at the time of implant. At one month post-implant,will be randomized 1:1 to Active or Sham stimulation. For those randomized tohe Active group, stimulation will be enabled. Participants will be blinded to their owndomization status until the 2nd GTC occurs for that individual, they completed the 9-monthveness 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 theham group (responsive stimulation OFF) will have responsive stimulation enabled (responsiveulation ON).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Epilepsy, Idiopathic Generalized Epilepsy, Generalized Tonic Clonic Seizure
  • Age: 12 years or above
  • Gender: All

Inclusion Criteria:
  • Participant is age 12 and older.
  • Participant is male or is a female of childbearing potential who is surgically2 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 indoses) with adequate monitoring of compliance and the effects ofdetermined by the investigator.
  • Participant is able to maintain an electronic diary alone or with the assistance of adividual.
  • Participant is able to attend clinic appointments in accordance with the studyhedule.
  • Participant or parent(s) or legal representative have signed an IRB approved writtend consent/assent. The informed consent form or specific assent form, wherequired, 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 neurosurgicaldure.
  • Participant with a confirmed diagnosis of idiopathic generalized epilepsy experiencingy generalized tonic-clonic seizures, with or without myoclonic or absencezures, consistent with the International League against Epilepsy RevisedClassification of Seizures (2017).
  • Participant has had 2 or more generalized tonic-clonic seizures during the two monthve baseline.
  • Participant has had a routine electroencephalogram (EEG) within 2 years prior towith electroencephalographic features consistent with idiopathicgeneralized epilepsy; other concomitant anomalies must be explained by adequate pastdical history.
  • Participant has been on a stable antiseizure medication (ASM) regimen during the twoh retrospective baseline and is willing to remain on a stable ASM regimen duringhe prospective Baseline and throughout the Effectiveness Evaluation Period, ifdically possible; rescue benzodiazepine medications for acute seizure clusters ared.
  • 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 orbnormality likely to be associated with focal-onset seizures.
  • Participant does not have a vagus nerve stimulator (VNS, LivaNova) or Participant'sVNS is OFF during the two month retrospective baseline and participant is willing tokeep the VNS off during the study.
Exclusion Criteria:
  • Participant is pregnant.
  • Participant is participating in a therapeutic investigational drug or other deviceudy.
  • Participant is implanted with an electronic medical device that delivers electricalgy to the brain.
  • Participant requires procedures that are contraindicated based on current RNS Systembeling.
  • Participant has been diagnosed with active psychosis, major depression or suicidaldeation in the preceding year. Participants with post-ictal psychiatric symptoms needbe excluded.
  • In the opinion of the investigator, the participant has a clinically significant orunstable medical condition (including alcohol and/or drug abuse) or a progressivevous system disease.
  • Participant has a history of partial-onset seizures or EEG findings within the past 2years indicative of partial-onset or symptomatic generalized abnormalities.
  • Participant has been diagnosed with psychogenic or non-epileptic seizures in theding year.
  • Participant has experienced unprovoked status epilepticus in the preceding year.
  • Participant is taking any anticoagulants.

Updated on 13 Dec 2024. Study ID: NP10016

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