Changes

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.

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"/>