RNS® System Feasibility Study
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: RNS® System implantation; RNS® System responsive stimulation
Intervention description: Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.; The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Responsive Stimulation; Brain Stimulator; Epilepsy; Seizures

Summary:

      The RNS® System is intended to treat patients with medically refractory (hard to treat)
      epilepsy. The RNS® System Feasibility study is designed to demonstrate safety and evidence of
      effectiveness of the RNS® System to support the commencement of a pivotal clinical
      investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has simple partial seizures (motor or sensory) or complex partial seizures
             (with motor manifestations) with or without secondarily generalized seizures

          2. Subject has seizures that are distinct, stereotypical events that can be reliably
             counted, in the opinion of the investigator, by the subject or caregiver

          3. Subject has seizures that are severe enough to cause injuries or significantly impair
             functional ability in domains including employment, psychosocial, education and
             mobility

          4. Subject failed treatment with a minimum of two antiseizure medications (used in
             appropriate doses) with adequate monitoring of compliance and the effects of treatment

          5. Subject has remained on the same antiseizure medication(s) over the preceding three
             (3) months (independent of dose and other than acute, intermittent use of
             benzodiazepines)

          6. Subject has a minimum of four (4) or more countable seizures every month over the last
             three (3) months, as reported from the NeuroPace sponsored Prospective Seizure
             Frequency Clinical Investigation

          7. Subject is ≥ 18 years old and ≤ 65 years old

          8. Subject has undergone diagnostic testing that has established the epileptiform
             activity onset region(s) as part of his/her standard care to determine candidacy for
             epilepsy surgery

          9. Subject is male, or if female is using a reliable method of contraception (hormonal,
             barrier method, surgical or abstention), or is at least two years postmenopause

         10. Subject or legal guardian is able to provide appropriate consent to participate

         11. Subject can be reasonably expected to maintain a seizure diary alone or with the
             assistance of a competent individual

         12. Subject is able to complete regular office visits and telephone appointments per the
             protocol requirements

         13. Subject is willing to be implanted with the RNS® System as a treatment for his/her
             seizures

         14. Subject is able to tolerate a neurosurgical procedure

         15. Subject is considered a good candidate to be implanted with an RNS® System

        Note: 1 month = 28 days

        Exclusion Criteria:

          1. Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding
             year

          2. Subject has been diagnosed with primarily generalized seizures

          3. Subject has experienced unprovoked status epilepticus in the preceding year

          4. In the opinion of the investigator, the subject has a clinically significant or
             unstable medical condition or a progressive central nervous system disease

          5. Subject has been diagnosed with active psychosis, severe depression or suicidal
             ideation in the preceding year

          6. Subject is pregnant or planning on becoming pregnant in the next year

          7. Subject is on the ketogenic diet

          8. Subject was enrolled in a therapeutic investigational drug or device study in the
             preceding year

          9. Subject has an implanted Vagus Nerve Stimulator (VNS)

         10. Subject has had therapeutic surgery to treat epilepsy in the preceding year

         11. Subject is implanted with an electronic medical device that delivers electrical energy
             to the head or body

         12. Subject is on chronic anticoagulants or, in the opinion of the investigator, subject
             is an unsuitable candidate for cranial surgery for any other reason

         13. Subject had a cranial neurosurgical procedure in the previous month

         14. Subject requires repeat MRIs

         15. Subject's seizure onset zone(s) is/are located below the level of the subthalamic
             nucleus or, in the opinion of the investigator, the necessary lead placement would
             present too high a risk

        Note: Subjects with an inactive VNS could be enrolled so long as the VNS was explanted
        prior to or at the same time as the RNS® System implant. Subjects who had had epilepsy
        surgery (resective, corpus callosotomy or ablation) greater than one year ago were still
        eligible.