RNS System RESPONSE Study (RESPONSE)

This is an interventional treatment trial for Epilepsy focused on measuring Adolescent, Medically refractory, Responsive neurostimulation, Focal onset seizures, RNS System Read More

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subject has been diagnosed with primarily generalized seizures.
• Subject requires procedures that are contraindicated based on current RNS System labeling.
• 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 is pregnant.
• Subject is participating in a therapeutic investigational drug or other device study.
• Subject is implanted with an electronic medical device that delivers electrical energy to the brain.
• Subject has been diagnosed with psychogenic or non-epileptic seizures.
• 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).