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

2. The RNS™ System
Cranially implanted battery powered responsive neurostimulator
Connected to 2 leads (depth and/or subdural) with 4 electrode contacts each

3. 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 /ncpneuro0750

4. The RNS® System: Responsive Stimulation
Patient Data
Management System (PDMS)
Neurostimulator and Leads
Programmer
Patients are provided a Wand and Remote Monitor to use at home to transfer information from the Neurostimulator to the PDMS through the internet.
Remote Monitor 4

5. 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)
[insert script]   5

6. 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

7. 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
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 patient’s clinical response.

8. 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.

9. Single Patient Seizure Plot: 2009-2014
Red: disabling seizures, Green: auras; Black: total seizures

10. 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

11. Study Design
Morrell M J Neurology 2011;77:

12. The NeuroPace Responsive Neurostimulator (RNS®) System TRIAL RESULTS
Overall:
38% Seizure Reduction in Active Treatment
17% Seizure Reduction in Sham Treatment

13. Other outcomes Improved quality of life in treated group
No difference in memory function between treated and sham groups

14. 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

15. - Those with 1 focus were more likely to be seizure-free
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
Many had improvement in cognitive functioning
Seizure frequency percent change by subject: most recent 3 months.
© 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.
Epilepsia Volume 55, Issue 3, pages , 22 FEB 2014 DOI: /epi

16. 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 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