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RNS® System

240 bytes added, 00:14, 1 December 2016
reference
category=Deep brain stimulation|
developer=NeuroPace, Inc. Mountain View, California|
developer_commentary=<ref name="neuropacecompany">NeuroPace. Company Overview. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/about-us-corporate/ (Retrieved 4.11.2016)</ref>|
announced=December, 2009 |
announced_commentary=<ref name="newsmedical">NOVELLI, P. NeuroPace announces clinical trial results demonstrating the RNS System. News medical life sciences [online]. 2009, Dec 9. Available online at: http://www.news-medical.net/news/20091209/NeuroPace-announces-clinical-trial-results-demonstrating-the-RNS-System.aspx (Retrieved 4.11.2016)</ref><ref> Pivotal Trial Data Demonstrate NeuroPace RNS® System Reduced Seizures in People with Epilepsy. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/pivotal-trial-data-demonstrate-neuropace/ (Retrieved 4.11.2016)</ref>|
price_commentary=(estimated)<ref name="USCNews">TRINIDAD, T. Keck Medicine physicians first to implant epilepsy-controlling device. USC News [online]. 2013, Dec 19. Available online at: https://news.usc.edu/57947/keck-medicine-physicians-become-first-to-implant-epilepsy-controlling-device/ (Retrieved 4.11.2016)</ref> |
max_output=11.5 mA|
max_output_commentary=± 10%, at 500 Ohms; <ref name="NeuropaceSystemUserManual>NeuroPace. RNS® System User Manual. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/wp-content/uploads/2016/08/RNS_System_User_Manual.pdf (Retrieved 4.11.2016)</ref>|
max_session_duration=5|
max_session_duration_commentary=(min 10 msec)<ref name="NeuropaceSystemUserManual"/>|
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RNS® System is medical device for epilepsy treatment.<ref name="neuropaceAbout_the_technology">NeuroPace. About the technology. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/the-rns-system/ (Retrieved 4.11.2016)</ref> It can monitor and stimulate brain activity, for it is deep brain stimulation device. It is manufactured by privately held company named NeuroPace, which is located in Montain View, California.<ref name="BusinessWirePhoenixConference">NeuroPace RNS® System Honored With Prestigious Award At The 22nd Annual Phoenix Conference. Business Wire: A Berkshire Hathaway Company [online]. 2015, Nov 4. Available online at: http://www.businesswire.com/news/home/20151104005381/en/NeuroPace-RNS%C2%AESystem-Honored-Prestigious-Award-22nd (Retrieved 4.11.2016)</ref> Therapy with RNS System consist in reducing the frequency of seizures in individuals<ref name="NeuropaceSystemUserManual"/>, who have partial-onset, medically refractory (drug resistant) epilepsy.<ref name="NCBI">THOMAS, G.P., JOBST, B.C. Critical review of the responsive neurostimulator system for epilepsy. The National Center for Biotechnology Information [online]. 2015, Oct 1. Available online at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4598207/ (Retrieved 4.11.2016)</ref> Those patients are treated with RNS System, when they have no more than two epileptogenic foci (epileptogenic focus is the source or starting point of seizures) and are resistant to more than two antiepileptic medications. The RNS System is thus only for medical prescription.
== Main characteristics ==
Plain device consist of:
* RNS Neurostimulator, which is a responsive electrical stimulation medical device (battery powered and microprocessor controlled) <ref name="NeuropaceSystemUserManual"/> Responsive electrical stimulation is a new approach to treating epilepsy and RNS System is the first device to provide it. <ref name="epilepsyResponsiveNeurostimulation>SIRVEN, J.I. Responsive Neurostimulation. Epilepsy Foundation [online]. 2014, May. Available online at: http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/devices/responsive-neurostimulation (Retrieved 4.11.2016)</ref> RNS Neurostimulator indicates and records certain patterns in the brain (electrocoticographic, ECoG patterns), which caused seizures. Then delivers short trains of current pulses through the leads to interrupt those patterns. Each stimulation can contain two bursts. Neurstimulator must be implanted in the skull together with leads.<ref name="NeuropaceSystemUserManual"/> The Neurostimulator should work for about 2 to 3.5 years before battery power is drained. It has size 28 x 60 mm, so it is relatively small.<ref name="NeuropaceSystemPatientManual">NeuroPace. NeuroPace® RNS® System
Patient Manual. NeuroPace, Inc [online]. © 2016. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100026C.pdf (Retrieved 4.11.2016</ref>
== Important Dates ==
* May 2023 - The completion of study for long time effect of the brain stimulation<ref name="RNS® System Epilepsy PAS"/>* November 14, 2013 - FDA Premarket Approval for the NeuroPace® RNS® System<ref name="FDA Grants Premarket Approval">U.S. Food and Drug Administration. FDA Grants Premarket Approval (PMA) for the NeuroPace® RNS® System to treat Medically Refractory Epilepsy. NeuroPace , Inc. [online]. 2013, Nov. Available online at: http://www.neuropace.com/wp-content/uploads/2015/11/NeuroPace_Press_Release_PMA_Approval_2013-11-14.pdf(Retrieved 6.11.2016</ref>
* January 19, 2004 - the first patient of the Feasibility Study<ref name="SSFD"/>
* December 29, 2005 - start of the Pivotal Study<ref name="SSFD"/>
'''Epilepsy'''
Epilepsy or “seizure disorder” is a chronic disorder, which cause unpredictable seizures of all kinds, which might have all sorts of other consequences. Epilepsy usually has not simple or known cause.<ref name="epilepsyWhatIsEpilepsy">SIRVEN, J.I. What Is Epilepsy? Epilepsy Foundation [online]. 2014, Jan. Available online at: http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy (Retrieved 4.11.2016)</ref> It might be caused some illness (for example brain tumors or Alzheimer’s disease<ref name="NIH_The_Epilepsies_and_Seizures">National Institute of Neurological Disorders and Stroke. The Epilepsies and Seizures. National Institute of Neurological Disorders and Stroke [online]. 2015, Aug, NIH Publication No. 15-156. Available online at: http://www.ninds.nih.gov/disorders/epilepsy/curing_the_epilepsies_brochure.pdf (Retrieved 4.11.2016)</ref>, brain damage, abnormal brain development, genetic mutation (de novo mutations) etc..<ref name="NIH_The_Epilepsies_and_Seizures"/> But those causes might be very diverse. Epilepsy always arises from brain and is bound to sudden abnormal brain electrical activity.<ref name="NIH_The_Epilepsies_and_Seizures"/> Clusters of neurons might fire signal faster than normal, which is as many as 500 times a second. That electric activity then cause seizure.<ref name="NIH_The_Epilepsies_and_Seizures"/> This medical condition is considered, when individual has at least two or more unprovoked seizures separated by 24 hours.<ref name="NIH_The_Epilepsies_and_Seizures"/> In the United States suffer from epilepsies up to 2.3 million adults and more than 450,000 children. <ref name="NIH_The_Epilepsies_and_Seizures"/>
There are many possible triggers of seizures in epilepsy.<ref name="NIH_The_Epilepsies_and_Seizures"/> The most common perceived triggers are: missing medication (40.9%), emotional stress (31.3%), sleep deprivation (19.7%), fatigue (15.3%), missing meals (9.1%), fever (6.4%), and smoking (6.4%). Data was obtained form 405 patinets.<ref name="Perceived trigger factors of seizures in persons with epilepsy">BALAMURUGAN, et al. Perceived trigger factors of seizures in persons with epilepsy. Seizure: Eur J EpilepsyElsevier Inc., 2013, Vol. 33, Iss. 9, pp 743 - 747. Available online at: http://www.seizure-journal.com/article/S1059-1311(13)00177-5/pdf (Retrieved 4.11.2016)</ref> There are more than 30 different types of seizures, but generally they are divided into two major groups – the focal seizures, which originate only in one part of the brain, and the generalized seizures, which come from both sides of the brain.<ref name="NIH_The_Epilepsies_and_Seizures"/> These seizures might look very different, they might or might not cause loss of consciousness, or a muscle´s massive contractions. It might also appear, for example in the intense feeling of déjà vu. Epilepsy has also many various types, for example the absence epilepsy, the frontal lobe epilepsy, the temporal lobe epilepsy (most common form in focal seizures) or the neocortical epilepsy.<ref name="NIH_The_Epilepsies_and_Seizures"/>
Epilepsy has also some risks associated with the life-threatening conditions, such as "status epilepticus" and "sudden unexpected death". However these cases are very rare. More common risks appear in connection with the injury during seizures.<ref name="NIH_The_Epilepsies_and_Seizures"/>
The implanted devices also might negatively interact with another medical procedures, such as Computed Tomography or MR (magnetic resonance).<ref name="NeuropaceSystemPatientManual"/> It might also cause allergic reaction, skin erosion (around the Neurostimulator), lead migration (move from their desired implant location) etc. There always remain a risk of failure the RNS devices.<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 Epilepsia [online], 2015, Vol. 56, No. 11, pp. 20151836–1844. 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>
* Benefits
So it is clear that the RNS System is risky, but at the same time it helps people with epilepsy to reduce seizures. It still does not help every patient with epilepsy, because the RNS System is designed only to certain type of the epileptic condition. 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. Elsevier Inc., 2015, SepVol. 84, Iss. 3, pp. World Neurosurgery719 - 726. Available online at: http://www.worldneurosurgery.org/article/S1878-8750(15)00479-9/references (Retrieved 7.11.2016)</ref>
'''Ethical Issues'''
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