At a glance
ClinicalIndex Comparison Record- ✓Simple partial or complex partial seizures (motor manifestations) ± secondary generalization
- ✓Seizures are distinct, stereotypical, and reliably countable by subject or caregiver
- ✓Seizures severe enough to cause injury or significantly impair function (employment, psychosocial, education, mobility)
- ✓Failed ≥2 antiseizure medications at appropriate doses with documented compliance
- ✕Diagnosed with psychogenic or non-epileptic seizures in preceding year
- ✕Primarily generalized seizures
- ✕Unprovoked status epilepticus in preceding year
- ✕Clinically significant/unstable medical condition or progressive CNS disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RNS® System Feasibility Clinical Investigation
In Brief
A Phase 2 clinical trial evaluating RNS® System implantation and RNS® System responsive stimulation for Epilepsy. Completed, enrolled 70 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.