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Transcript of Responsive Neurostimulation (RNS) for the treatment of epilepsy Daniel Friedman, MD Assistant...
Responsive Neurostimulation (RNS) for the treatment of epilepsy
Daniel Friedman, MDAssistant Professor
NYU Comprehensive Epilepsy CenterApril 27, 2014
The RNS™ System
• Cranially implanted battery powered responsive neurostimulator
• Connected to 2 leads (depth and/or subdural) with 4 electrode contacts each
Stacey WC and Litt B (2008) Technology Insight: neuroengineering and epilepsy—designingdevices for seizure control
Nat Clin Pract Neurol 10.1038/ncpneuro0750
Figure 3 The NeuroPace Responsive Neurostimulator (RNS®) System (Mountain View, CA)
The RNS® System: Responsive Stimulation
Neurostimulatorand Leads
Patient Data Management System
(PDMS) Programmer
Remote Monitor
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)
The RNS™ System
Neurostimulator detects and stimulates abnormal brain electrical activity with implanted electrodes
Programmer sets detection and stimulation parameters
Programmer and PatientData Transmitter send
ECoG data to web-based repository for review
RNS® System: Responsive Stimulation
• Physician identifies electrocortico-graphic activity to be detected
• Detection and stimulation settings programmed, then adjusted as needed
• Varied seizure patterns require individualized settings
Patient Data Management System
Caution: 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 seizures
The NeuroPace Responsive Neurostimulator (RNS®)
System Trial
• 191 patients; 32 centers• Randomized to Treatment vs.
Sham group for 3 months• Need to know localization of
epileptic brain tissue 1- 2 foci• 3 or more disabling seizures
per month
Study Design
Morrell M J Neurology 2011;77:1295-1304
The NeuroPace Responsive Neurostimulator (RNS®) System TRIAL RESULTS
Overall: • 38% Seizure
Reduction in Active Treatment
• 17% Seizure Reduction in Sham Treatment
Other outcomes
• Improved quality of life in treated group• No difference in memory function between
treated and sham groups
Safety
• Bleeding in the brain in 2.3%• Infection of scalp/soft tissue in 5.3% (4 pts had
to have device removed); no brain infection• Other rarer side effects included pain,
abnormal sensations related to stimulation and worsening seizures
Two year 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.12534http://onlinelibrary.wiley.com/doi/10.1111/epi.12534/full#epi12534-fig-0005
At 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 functioning
Treatment with RNS – Patient perspective
• Localize seizure onset regions using EEG, MRI, PET, MEG, SPECT and/or intracranial EEG
• RNS leads and stimulator implanted & recording activated– Patient uploads data daily
• Post-op visit 10-14 days– Data reviewed, detectors adjusted if necessary, stimulation activated
• Follow up visits ~ 1-3 months– Data reviewed, detectors and stimulation parameters adjusted– Patient continues to upload data every 1-7 days
• Long term follow-up, every 3 months– Continue to upload data– Monitor battery/device function– Adjust parameters as necessary
• Battery change about every 2 years, may be longer/shorter