RNS System NAUTILUS Study

Launched by NEUROPACE · Dec 6, 2021

Keywords

ClinConnect Summary

The RNS System NAUTILUS Study is a clinical trial that is exploring a new treatment option for people aged 12 and older who have a type of epilepsy known as idiopathic generalized epilepsy, which causes seizures that can be difficult to control with medication. Specifically, this study is looking at whether a device called the RNS System, which stimulates a part of the brain called the thalamus, can help reduce the number of these seizures in individuals who have not found relief from at least two different seizure medications.

To participate in this study, individuals must be at least 12 years old and have been diagnosed with idiopathic generalized epilepsy, experiencing multiple seizures in a two-month period. They should have already tried and not succeeded with two different antiseizure medications. Participants will need to keep an electronic diary of their seizures and attend regular clinic appointments. Additionally, they should not have any other electronic devices implanted in their body that affect the brain, and they must be in good overall health. This trial is currently active, but it is not recruiting new participants at this time. If you or someone you know is considering this option, it’s important to discuss it with a healthcare provider to fully understand what involvement would entail.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.