RNS System RESPONSE Study
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: October 27, 2021
End Date: December 31, 2027
Sharon McFadden
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).
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Conditions:
- Epilepsy
- Seizures
- Drug Resistant Epilepsy
- Epilepsies, Partial