ID#: NCT04839601

Age: 12 - 17 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 27, 2021

End Date: December 31, 2027

Contact Information:
Felicia Elefant
Sharon McFadden
Summary: To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.

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).