The RNS System: responsive cortical stimulation for the treatment of refractory partial epilepsy

Abstract

The RNS^® System is the first commercially available device to provide closed-loop responsive brain stimulation. The system includes a cranially implanted neurostimulator that continually monitors the electrocorticogram through one or two depth and/or subdural cortical strip leads that are placed at the seizure focus. When abnormal electrographic activity is detected, the neurostimulator delivers brief pulses of electrical stimulation to the seizure focus through the implanted leads. In November 2013, the US FDA approved the RNS System as an adjunctive therapy for patients with drug resistant, partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci. Safety and effectiveness of the RNS System for the indicated patient population was demonstrated in a multicenter, randomized, sham-stimulation controlled 2-year pivotal study. An ongoing, prospective, long-term treatment study is currently gathering an additional 7 years of prospective safety and effectiveness data of the RNS System.

Keywords::

• brain stimulation
• closed-loop
• epilepsy therapy
• focal seizures
• neurostimulator
• partial seizures
• RNS System

Financial & competing interests disclosure

F Sun is a contractor for NeuroPace, Inc. M Morrell is an employee and officer of NeuroPace, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The RNS System is the first device to provide closed-loop responsive brain stimulation. The neurostimulator continually monitors the electrocorticogram and delivers brief pulses of electrical stimulation when abnormal activity is detected.

• A multicenter, randomized, sham-stimulation-controlled 2-year pivotal study provided Class I level evidence of the safety and effectiveness of responsive stimulation using the RNS System for treating patients with drug resistant, partial-onset epilepsy.

• In 2013, the US FDA approved the RNS System as an adjunctive therapy in individuals 18 years of age or older with partial-onset seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci, are refractory to two or more antiepileptic medications and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/ or secondarily generalized seizures).

• An ongoing, prospective, long-term treatment study is currently gathering an additional 7 years of prospective safety and effectiveness data of the RNS System for the intended population.

Notes