Responsive Neurostimulation (RNS) for the treatment of epilepsy Daniel Friedman, MD Assistant Professor NYU Comprehensive Epilepsy Center April 27, 2014

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Responsive Neurostimulation (RNS) for the treatment of epilepsyDaniel Friedman, MDAssistant Professor NYU Comprehensive Epilepsy CenterApril 27, 2014

The RNS SystemCranially implanted battery powered responsive neurostimulatorConnected to 2 leads (depth and/or subdural) with 4 electrode contacts each


Stacey WC and Litt B (2008) Technology Insight: neuroengineering and epilepsydesigningdevices for seizure controlNat Clin Pract Neurol 10.1038/ncpneuro0750Figure 3 The NeuroPace Responsive Neurostimulator (RNS) System (Mountain View, CA)

The RNS System: Responsive StimulationNeurostimulatorand LeadsPatient Data Management System (PDMS) Programmer

Remote Monitor

4Patients are provided a Wand and Remote Monitor to use at home to transfer information from the Neurostimulator to the PDMS through the internet.

RNS System Indication The RNS System is an adjunctive therapy for:

>18 years of age

partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci

refractory to two or more antiepileptic medications

have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures) 5[insert script] The RNS SystemNeurostimulator detects and stimulates abnormal brain electrical activity with implanted electrodesProgrammer sets detection and stimulation parametersProgrammer and PatientData Transmitter send ECoG data to web-based repository for review

RNS System: Responsive StimulationPhysician identifies electrocortico-graphic activity to be detectedDetection and stimulation settings programmed, then adjusted as neededVaried seizure patterns require individualized settings

Here are examples of detections and stimulations in 3 different patients.This is the type of data the physician can review on the programmer or the PDMS. The physician programs the Neurostimulator to detect and briefly stimulate specific electrocorticographic activity of interest. The arrows indicate the detection, followed by the stimulation. The physician reviews these recordings, determines if the stimulation is having the desired effect, and then adjusts detection and stimulation based on the patients clinical response.

Patient Data Management SystemCaution: InvestigationalDevice. Limited by US Law to Investigational Use Only.Caution: investigational device. Limited by US law to investigational use only.

Single Patient Seizure Plot: 2009-2014

Red: disabling seizures, Green: auras; Black: total seizuresThe NeuroPace Responsive Neurostimulator (RNS) System Trial191 patients; 32 centersRandomized to Treatment vs. Sham group for 3 monthsNeed to know localization of epileptic brain tissue 1- 2 foci3 or more disabling seizures per month

Study Design

Morrell M J Neurology 2011;77:1295-1304The NeuroPace Responsive Neurostimulator (RNS) System TRIAL RESULTSOverall: 38% Seizure Reduction in Active Treatment17% Seizure Reduction in Sham Treatment

Other outcomesImproved quality of life in treated groupNo difference in memory function between treated and sham groupsSafetyBleeding in the brain in 2.3%Infection of scalp/soft tissue in 5.3% (4 pts had to have device removed); no brain infectionOther rarer side effects included pain, abnormal sensations related to stimulation and worsening seizuresTwoyear seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial

EpilepsiaVolume 55, Issue 3, pages 432-441, 22 FEB 2014 DOI: 10.1111/epi.12534 the end of 2years of treatment, 9% were seizure free during the last 3 mo- Those with 1 focus were more likely to be seizure-free

~7% had worsening of seizures

Many had improvement in cognitive functioning15Seizure frequency percent change by subject: most recent 3months.

This slide is made available for non-commercial use only. Please note that permission may be required for re-use of images in which the copyright is owned by a third party.Treatment with RNS Patient perspectiveLocalize seizure onset regions using EEG, MRI, PET, MEG, SPECT and/or intracranial EEGRNS leads and stimulator implanted & recording activatedPatient uploads data dailyPost-op visit 10-14 daysData reviewed, detectors adjusted if necessary, stimulation activatedFollow up visits ~ 1-3 monthsData reviewed, detectors and stimulation parameters adjustedPatient continues to upload data every 1-7 daysLong term follow-up, every 3 monthsContinue to upload dataMonitor battery/device functionAdjust parameters as necessaryBattery change about every 2 years, may be longer/shorter