RNS® System Feasibility Clinical Investigation

Date de début de l'étude : 1 janvier 2004

Inclusion Criteria: 1. Subject has simple partial seizures (motor or sensory) or complex partial seizures (with motor manifestations) with or without secondarily generalized seizures 2. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or caregiver 3. Subject has seizures that are severe enough to cause injuries or significantly impair functional ability in domains including employment, psychosocial, education and mobility 4. Subject failed treatment with a minimum of two antiseizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment 5. Subject has remained on the same antiseizure medication(s) over the preceding three (3) months (independent of dose and other than acute, intermittent use of benzodiazepines) 6. Subject has a minimum of four (4) or more countable seizures every month over the last three (3) months, as reported from the NeuroPace sponsored Prospective Seizure Frequency Clinical Investigation 7. Subject is ≥ 18 years old and ≤ 65 years old 8. Subject has undergone diagnostic testing that has established the epileptiform activity onset region(s) as part of his/her standard care to determine candidacy for epilepsy surgery 9. Subject is male, or if female is using a reliable method of contraception (hormonal, barrier method, surgical or abstention), or is at least two years postmenopause 10. Subject or legal guardian is able to provide appropriate consent to participate 11. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual 12. Subject is able to complete regular office visits and telephone appointments per the protocol requirements 13. Subject is willing to be implanted with the RNS® System as a treatment for his/her seizures 14. Subject is able to tolerate a neurosurgical procedure 15. Subject is considered a good candidate to be implanted with an RNS® System Note: 1 month = 28 days Exclusion Criteria: 1. Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding year 2. Subject has been diagnosed with primarily generalized seizures 3. Subject has experienced unprovoked status epilepticus in the preceding year 4. In the opinion of the investigator, the subject has a clinically significant or unstable medical condition or a progressive central nervous system disease 5. Subject has been diagnosed with active psychosis, severe depression or suicidal ideation in the preceding year 6. Subject is pregnant or planning on becoming pregnant in the next year 7. Subject is on the ketogenic diet 8. Subject was enrolled in a therapeutic investigational drug or device study in the preceding year 9. Subject has an implanted Vagus Nerve Stimulator (VNS) 10. Subject has had therapeutic surgery to treat epilepsy in the preceding year 11. Subject is implanted with an electronic medical device that delivers electrical energy to the head or body 12. Subject is on chronic anticoagulants or, in the opinion of the investigator, subject is an unsuitable candidate for cranial surgery for any other reason 13. Subject had a cranial neurosurgical procedure in the previous month 14. Subject requires repeat MRIs 15. Subject's seizure onset zone(s) is/are located below the level of the subthalamic nucleus or, in the opinion of the investigator, the necessary lead placement would present too high a risk Note: Subjects with an inactive VNS could be enrolled so long as the VNS was explanted prior to or at the same time as the RNS® System implant. Subjects who had had epilepsy surgery (resective, corpus callosotomy or ablation) greater than one year ago were still eligible.