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Some danger might arise also from hacker´s attack. The device interacts with the programmer, which is possible to replicates and then operates the Neurostimulator. But according to Frank Fisher, the CEO of the NeuroPace, it is very unlikely due to the fact, that it is significantly difficult and there is neither a reason for someone to do that. <ref name="NeuroPace: Controlling Epilepsy With a Brain Implant">NeuroPace: Controlling Epilepsy With a Brain Implant. Interwiev with Frank Fischer, the CEO of NeuroPace, Inc. IEEE Spectrum [online]. 2013, Nov 5. Available online at: http://spectrum.ieee.org/podcast/biomedical/bionics/neuropace-controlling-epilepsy-with-a-brain-implant (Retrieved 6.11.2016)</ref> ''Benefits''
Ethical & Health Issues
== Ethical & Health Issues ==
'''Health Issues''' The use of RNS System is a relatively severe intervention in the brain and thus involves several health risks.So most of the risks are rather connected with health issues than with ethical issues. ''Risks''
First of all there are some risks associate with surgery to implant the RNS Neurostimulator and Leads: post-implant infection (7%) and bleeding in the brain or under the skull because of the implant (4.7%). After about 2 or 3 years of using, the Neurostimulator have to be replaced with the new one, so the patient must get through another surgery. However the second one is not so dangerous, because the doctor will not have to do any surgery on the bone.<ref name="NeuropaceSystemPatientManual"/>
Serious risk might also come out from unknown effect of long-term brain stimulation.<ref name="NeuropaceSystemPatientManual"/> This conclusion support as well study conducted by Loring, Kapur, Meador and Morrell.<ref name="Differential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy">LORING, D.W., KAPUR, R., MEADOR, K.J., MORRELL, M.J. Differential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy. Wiley Online Library [online]. 2015. Available online at: http://onlinelibrary.wiley.com/doi/10.1111/epi.13191/epdf (Retrieved 6.11.2016)</ref> It is probably too soon to determine exact effect of the brain stimulation. The study for long time effect of the brain stimulation is still under way and the estimated completion date is May 2023. <ref name="RNS® System Epilepsy PAS">RNS® System Epilepsy PAS. ClinicalTrials.gov [online]. 2016, Sep. Available online at: https://clinicaltrials.gov/ct2/show/results/NCT02403843 (Retrieved 6.11.2016)</ref>
On the other hand there are clear benefits of the RNS System. It was demonstrated that the RNS System significantly reduce epileptic seizures. According to clinical studies (Pivotal study – 191 subjects and Feasible study – 65 subjects), treatment patients come to the monthly reduction in seizure frequency averaging 37.9% compared to a 17.3% reduction in the Sham group (control group).<ref name="NeuropaceSystemPatientManual"/>
However according to Thomas and Jobst the RNS System might not be as effective in seizure reduction as epilepsy surgery.<ref name="NCBI"/> On the other hand, epilepsy surgery is not always appropriate for certain type of epileptic illness. The RNS System thus remains suitable alternative to treat epilepsy. Similar conclusion also supports The University of Southern California (USC) Neurorestoration Center and the Keck Hospital of USC, that are the world's first institutions to implant the RNS System post FDA approval. They confirm that:
''"The RNS System can be readily incorporated into an active epilepsy surgical center."''<ref name="A Single-Center Experience with the NeuroPace RNS System">LEE, B., ZUBAIR, M.N., MARQUEZ, Y.D., LEE, D.M., KALAYJIAN, L.A., HECK, C.N., LIU, C.Y. A Single-Center Experience with the NeuroPace RNS System: A Review of Techniques and Potential Problems. 2015, Sep. World Neurosurgery. Available online at: http://www.worldneurosurgery.org/article/S1878-8750(15)00479-9/references (Retrieved 7.11.2016)</ref> '''Ethical Issues''' Some danger might arise also from hacker´s attack. The device interacts with the programmer, which is possible to replicates and then operates the Neurostimulator. But according to Frank Fisher, the CEO of the NeuroPace, it is very unlikely due to the fact, that it is significantly difficult and there is neither a reason for someone to do that. <ref name="NeuroPace: Controlling Epilepsy With a Brain Implant">NeuroPace: Controlling Epilepsy With a Brain Implant. Interwiev with Frank Fischer, the CEO of NeuroPace, Inc. IEEE Spectrum [online]. 2013, Nov 5. Available online at: http://spectrum.ieee.org/podcast/biomedical/bionics/neuropace-controlling-epilepsy-with-a-brain-implant (Retrieved 6.11.2016)</ref>
== Public & Media Impact and Presentation ==
