Clinical Research Directory

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.