RNS System RESPONSE Study

Ki vehet részt

• Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility
• Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or parent/caregiver
• Subject had an average of three or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures over the two most recent consecutive 30-day periods, with no 30-day period with less than two seizures per subject and/or parent/caregiver report
• Subject failed treatment with a minimum of two anti-seizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator
• Subject has undergone diagnostic testing as part of his/her standard care that has identified no more than two epileptogenic regions
• Subject is male or a female of childbearing potential using a reliable method of contraception (hormonal, barrier method, surgical or abstention)
• Subject is age 12 or older but will be less than age 18 (has not reached 18th birthday) at the time of implantation with the RNS System
• Subject is able to maintain an electronic diary alone or with the assistance of a competent individual
• Subject is able to attend clinic appointments in accordance with the study schedule
• Subject and/or parent/guardian must be willing and able to provide informed consent and assent when appropriate
• Subject is not currently implanted with an RNS Neurostimulator or NeuroPace Leads
• In the investigator's opinion, subject is able to tolerate a neurosurgical procedure

Ki nem vehet részt

• Subject is participating in a therapeutic investigational drug or other device study
• Subject has been diagnosed with primarily generalized seizures
• In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease
• Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded
• Subject has been diagnosed with psychogenic or non-epileptic seizures
• Subject requires procedures that are contraindicated based on current RNS System labeling
• Subject is pregnant
• Subject is implanted with an electronic medical device that delivers electrical energy to the brain
• Subject has experienced unprovoked status epilepticus in the preceding year
• Subject is taking chronic anticoagulants; Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com)