RNS® System Feasibility Study
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      NeuroPace, Inc. is sponsoring an investigational device feasibility study of the RNS® System,
      the first closed loop responsive brain stimulator designed to treat medically refractory
      epilepsy. The RNS® System Feasibility study is a multi-center investigation being conducted
      at 12 epilepsy centers through the United States. The first 4 subjects at each site are
      entered into an open label protocol, and subsequent subjects at that site are entered into a
      randomized, double-blinded, sham-stimulation controlled protocol. The study is designed to
      demonstrate safety and evidence of effectiveness of the RNS® System to support commencement
      of a pivotal clinical investigation.

      The RNS® Neurostimulator (a pacemaker-like device) and NeuroPace® Leads (tiny wires with
      electrodes) are implanted in the head. The Neurostimulator is a battery powered,
      microprocessor controlled device that detects and stores records of electrographic patterns
      (such as epileptiform, or seizure-like, activity) from the Leads within the brain. When the
      device detects an electrographic pattern, it responds by sending electrical stimulation
      through the Leads to a small part of the patient's brain to interrupt the electrographic
      pattern. This type of treatment is called responsive stimulation, but it is not yet known if
      it will work for the treatment of epilepsy. Direct brain stimulation therapy has already
      received approval in the United States, Europe, Canada, and Australia for the treatment of
      Essential Tremor and Parkinson's disease. Direct brain stimulation is not approved for the
      treatment of epilepsy.

      Subjects participating in the RNS® System Feasibility study are required to have successfully
      completed the non-significant risk Prospective Seizure Frequency (PSF) study, which gathers
      baseline(pre-implant) seizure frequency data. Subjects must also met the inclusion criteria,
      including localization of epileptogenic region(s), prior to enrolling in the study.
      Throughout the entire study, subjects or their caregivers must keep a seizure diary. Seizure
      frequency, seizure severity, and antiepileptic medications, as well as physical and emotional
      health will be monitored and recorded throughout the study. Antiepileptic medications should
      continue to remain stable until 5 months post-implant.

      Following enrollment, and prior to RNS® System implant, subjects undergo a neuropsychological
      evaluation. During the implant procedure, the RNS® Neurostimulator is cranially implanted and
      connected to one or two NeuroPace® Leads implanted in the brain. The investigational team
      determines the placement of the Leads based on prior localization of the epileptogenic
      region, according to standard localization procedures.

      The Evaluation Period begins once the subject is implanted with the RNS® System and continues
      through the 4th month. Detection of epileptiform activity is enabled for all subjects within
      the first post-operative month. Responsive stimulation is enabled and optimized for subjects
      enrolled in the open label protocol or randomized to the Treatment group. Subjects randomized
      to the Sham group undergo simulated stimulation programming in order to maintain the
      treatment blind. Randomized subjects will not know whether responsive stimulation is being
      delivered or not.

      At the beginning of the 5th month, subjects transition into the Follow up Period during which
      all subjects may receive responsive stimulation and antiepileptic medications may be adjusted
      as medically required. Subjects will be followed for 2 years post-implant. Throughout study
      participation, both effectiveness and safety data will be monitored continuously, and
      reviewed and documented by the study investigator at study appointments scheduled every 1-3
      months.
    

Intervention name(s): RNS® System implantation; RNS® System responsive stimulation
Intervention type(s): Procedure; Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Responsive Stimulation; Brain Stimulator; Epilepsy; Seizures