RNS System RESPONSE Study

Inclusion Criteria:

• Subject has disabling motor simple partial seizures, complex partial seizures,and/or secondarily generalized seizures. Disabling refers to seizures that aresevere enough to cause injuries, or significantly impair functional ability indomains including employment, psychosocial education and mobility.

• Subject has seizures that are distinct, stereotypical events that can be reliablycounted, 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 mostrecent consecutive 30-day periods, with no 30-day period with less than two seizuresper subject and/or parent/caregiver report.

• Subject failed treatment with a minimum of two anti-seizure medications (used inappropriate doses) with adequate monitoring of compliance and the effects oftreatment, as determined by the investigator.

• Subject has undergone diagnostic testing as part of his/her standard care that hasidentified no more than two epileptogenic regions.

• Subject is male or a female of childbearing potential using a reliable method ofcontraception (hormonal, barrier method, surgical or abstention).

• Subject is age 12 or older but will be less than age 18 (has not reached 18thbirthday) at the time of implantation with the RNS System.

• Subject is able to maintain an electronic diary alone or with the assistance of acompetent 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 consentand 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 neurosurgicalprocedure.

Exclusion Criteria:

• Subject has been diagnosed with primarily generalized seizures.

• Subject requires procedures that are contraindicated based on current RNS Systemlabeling.

• In the opinion of the investigator, the subject has a clinically significant orunstable medical condition (including alcohol and/or drug abuse) or a progressivecentral nervous system disease.

• Subject has been diagnosed with active psychosis, major depression or suicidalideation in the preceding year. Subjects with post-ictal psychiatric symptoms neednot be excluded.

• Subject is pregnant.

• Subject is participating in a therapeutic investigational drug or other devicestudy.

• Subject is implanted with an electronic medical device that delivers electricalenergy 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).