Transcript Part I - FACES

Responsive Neurostimulation (RNS)
for the treatment of epilepsy
Daniel Friedman, MD
Assistant Professor
NYU Comprehensive Epilepsy Center
April 27, 2014
The RNS™ System
• Cranially implanted
battery powered
responsive
neurostimulator
• Connected to 2 leads
(depth and/or
subdural) with 4
electrode contacts
each
Figure 3 The NeuroPace Responsive Neurostimulator (RNS®)
System (Mountain View, CA)
Stacey WC and Litt B (2008) Technology Insight: neuroengineering and epilepsy—designing
devices for seizure control
Nat Clin Pract Neurol 10.1038/ncpneuro0750
The RNS® System: Responsive Stimulation
Neurostimulator
and Leads
Remote Monitor
Programmer
Patient Data
Management System
(PDMS)
®
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 Patient
Data 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: 20092014
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
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
Epilepsia
Volume 55, Issue 3, pages 432-441, 22 FEB 2014 DOI: 10.1111/epi.12534
http://onlinelibrary.wiley.com/doi/10.1111/epi.12534/full#epi12534-fig-0005
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