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The RNS System Technology Project Home
| The RNS System By: Katie Borschke, Isabelle Wallstein, Danielle Flis, Nick Mackie, and Mitch Ogren Part 1: Collaborative Investigation Katie Borschke The RNS System is a type of responsive stimulation for the treatment of Epilepsy. RNS stands for Responsive Neurostimulation System. As a part of this system, Neuropace Inc. has created a type of implantable device constructed to stop seizure activity in epilepsy patients before symptoms occur. At this point, Neuropace is only conducting clinical trials. The current success rate claims that out of 58 patients, 7 patients have remained completely free of seizures (Windhover Info, Inc). Approximately one million people in America have some form of seizure disorder (Birf, 2007). When the brain electrical activity is abnormal, the result can be a seizure. Some seizures last just a few seconds and are barely noticed, but others are more obvious seizures where the person loses consciousness, the whole body stiffens, then jerks and twitches uncontrollably (Birf, 2007). Epilepsy, the concentration disease of this technology, is when a person has more than one occurrence of seizures. (Birf, 2007) Below is a picture of the locations of the implant:  (NeuroPace, Milwaukee Journ.) To begin the surgery, the doctor inserts two thin electrodes about five inches into his brain, at the back of the patient’s head. They then carve out a section of the skull that is deep enough to cradle a device about the size of an iPod Shuffle. One end of the lead is placed within or on top of the brain near the area where seizures start. The battery and monitoring system (computer chip) are placed in the section of the skull that was carved out. The scalp is pulled back over the device, implanting the battery powered stimulator that is made up of tiny wires with electrodes. It includes a programmer for the study physician and a data transmitter for patients to provide information from the neurostimulator to the study physician. (Neuropace, 2008, Milwaukee Journal Sentinel) The RNS system has a main implanted device which is powered by a battery and contains a computer chip that detects and stores a record of the brain's electrical activity. The system is designed to deliver electricity only when needed, eliminating the possibility of continuously sending current into the brain (Neuropace, 2008, Milwaukee Journal Sentinel). The electrodes sense abnormal activity, allowing the brain to be IMMEDIATELY stimulated in response to a seizure. The stimulation settings are selected so that stimulation cannot be felt. Once the seizure has stopped, the current is turned off until it is needed again. Below is a chart showing the effects of stimulation of brain activity:  (Neuropace, 2008) Advancements over the years in neurotechnology make the RNS System possible. Neurotechnology is a field of science that edits the body and mind through the nervous system by electronics and mechanisms (Wiki, 2009). When the field of neuroscience began to organize in the 1960s, the experimental model was the laboratory rat (Wiki, 2009). Neuroscientists would implant stimulating or recording electrodes chronically into the rat brain and attempt to use electrical stimulation to change the behavior of the experimental animal. What happened in the rat brain yielded early insights into how the human brain might work. Continual technical refinements have now improved such experiments to the point where the firing of single neurons can be correlated with, and even cause, specific behaviors (Epilepsy, 2009). This is the belief behind Responsive Stimulation for the Treatment of Epilepsy. This implantable device from NeuroPace incorporates the same technology by zapping the problematic area and normalizing brain activity before the patient experiences seizure symptoms. The underlying principles and mechanisms referring to WHY brain stimulation is often successful are still not incredibly clear. However, what is known is how the brain’s activity influences seizure activity in the first place. This can be described by taking a deeper look into what functions are controlled by different parts of the brain and how they correlate with epileptic seizures and stimulation. The human brain is the source of human epilepsy. Although the symptoms of a seizure may affect any part of the body, the electrical events that produce the symptoms occur in the brain. The location of that event, the extent of its reach within the tissue of the brain, and how long it lasts all have profound effects. These three factors determine the character of the seizure, its impact on the individual, and the social consequences involved (EFCNW, 2009). Nerves throughout the body function like telephone lines; this enables the brain to communicate with every part of the body through electrical signals. In epilepsy, the brain's electrical rhythms are often imbalanced, resulting in recurrent seizures. Normally, the brain continuously generates tiny electrical impulses in an orderly pattern. These impulses travel along the network of nerve cells in the brain and throughout the whole body by the work of chemical messengers called neurotransmitters. A seizure occurs when the brain's nerve cells misfire and generate a sudden, uncontrolled surge of electrical activity in the brain. If seizures arise from a specific area of the brain, then the initial symptoms of the seizure often reflect the functions of that area. For example, it is known that the right half of the brain controls the left side of the body, and the left half of the brain controls the right side of the body, so if a patient is having the most trouble with right side of their body, then it is known that the area to connect the leads lies in the left side of the brain (Epilepsy, 2009). This is the process of figuring out where to put the leads of the RNS System in the patient’s brain. Through assessing personal seizure activity, it is often predicted where to position the different components of the implantation. The scientific concepts behind today’s advanced neurostimulation techniques have multiple aspects. There has been a long history of its development and many different technologies required in order to have acquired safe and effective results. Some of these include the development of TENS devices, the technology of skin electrodes, and the process of EEGs. Advancing technology of TENS devices have had a large impact on the field of neurostimulation. Without which, the RNS System would not be possible. The acronym TENS refers to transcutaneous electrical nerve stimulation. Coming about long before responsive neurostimulation, TENS is a non-invasive, safe method to reduce pain, both acute and chronic, much like the chronic life of many seizures in Epilepsy patients (en.wikipedia.org). A typical battery-operated TENS unit is also able to modulate pulse width, frequency and intensity. Minneapolis, Minnesota was a primary location to first create these types of devices and focus on electrical stimulation as way of managing pain. Also contributing to the success of stimulation has been the technology of skin electrodes. The original skin electrodes were developed as early as 1860 and originally were made up of rollers and brushes. Much like the leads used in the RNS system, their purpose is to transmit stable and clean signals for precise physiological measurements, without which, EEG’s would not be possible (Gereonics, 2009). EEGs are another part of the neurostimulation process. It stands for Electroencephalography, which is the recording of electrical activity along the scalp produced by the firing of neurons within the brain. Any person suspected of epilepsy is first given this type of assessment. An EEG begins by putting wires on the patient’s head and then connecting them to a TENS device, as is described above. Each of the wires measures the little electrical activity going on in the brain. This technology allows the physician to insert the NeuroPace device to the settings in which an individual’s seizure activity can be controlled (Birf, 2007). Such as in the RNS System, the main application of EEG is in the case of epilepsy, as epileptic activity can create clear abnormalities on a standard EEG study. The RNS system consists of an implantable device and separate external components. The implantable device includes the leads, electrodes, the main device, and the monitoring system. The leads are placed in the target area of the brain and are the main transfer system from which the electrical shock flows to the problem area. Implanted in the main device, the electrodes are small wires that are placed five inches in the brain to begin implantation. These help transmit the electronic pulses. Next, the main device, which is the size of an iPod Shuffle, holds a battery powered stimulator that is made up of the electrodes. Lastly, the monitoring system includes a computer chip that detects and stores a record of the brain’s electrical activity, located next to the battery device. External components include the programmer, a hand held wand, and a data transmitter. The programmer collects information from the RNS about brain electrical activity and is used to program the RNS to make detections and deliver responsive stimulation (Neuropace, 2009). It is a modified laptop computer which communicates with the RNS via a hand-held wand. It is used to program the detection and stimulation parameters of an implanted device. They can also view the patient's electrocorticographic activity (the practice of using electrodes placed directly on the exposed surface of the brain to record electrical activity from the cerebral cortex ) and upload the patient's ECoGs that have been stored in the RNS . The hand held wand is used to communicate with the RNS neurostimulator, as it sets off the system to record information. The last external component is given to the patients, the data transmitter. The patients are asked to upload data from the device to a private Internet site nearly every day (Neuropace, 2008, Milwaukee Journal Sentinel). The data is then studied and adjustments are sometimes made to the implant to more effectively counter the seizures. Neuropace is currently only performing clinical trials with this product. Their publications page warns that all trials involve risk and that the RNS System is no different. They claim that there may be side effects or bad reactions to the device or therapy. It is also stated that therapy could, in fact, even make the seizures worse. As mentioned above, this system does require brain surgery. All surgeries pose some risk, so the implantation process of the battery powered device, leads, and electrodes are no different. However, in follow ups that have been done anywhere from 6 months to 2 years after the operation as of February of 2009, there have yet to be any unanticipated negative events (Neuropace Publications, 2009). Bibliography:
Part 2: Investigating the Researcher Danielle Flis NeuroPace was founded by the Fischell family in 1997 and is based in California. The goal of the company is to design and develop implantable devices. These devices are working to treat neurological disorders by responsive brain stimulation. The main disorder that this company is trying to treat is epilepsy. Epilepsy is a debilitating neurological disorder that affects approximately 1% of the worldwide population. NeuroPace is growing rapidly and is already taking in two billion dollars annually. At this rate, NeuroPace has the potential to become the global leader in the neurological market (company.com). The new technology that NeuroPace is in the process of creating is a responsive neurostimulator system (RNS) for the treatment of medically refractory partial epilepsy. This technology senses the onset of a seizure. The RNS is made up of implantable components that include neurostimulators that deliver short electrical pulses to the brain. The new technology also includes external products, including the programmer and a laptop computer (investing.com). There are three main inventors for the new epilepsy responsive neurostimulation treatment technology. The main researcher and inventor of this project is Dr. David R. Fischell. Dr. Fischell has gone through strict training and education and has helped develop and broaden the biomedical world. He attended Cornell University where he first received his bachelors of science in Engineering Physics in 1975, then continued on to receive a masters degree in Applied Physics in 1978, and finally in 1980 received a doctorate degree in Applied Physics. After Dr. Fischell graduated from college, he worked for AT&T’s Bell Laboratories for 11 years. He was involved in many research projects and inventions while working at Bell (Cornell.edu). Dr. David Fischell left Bell Laboratories in 1991 to work with his father Dr. Robert Fischell and his brother, Dr. Tim Fischell, as an entrepreneur, inventing medical devices. He wanted to start inventing because he believed, “…my father was having more fun than I was,” (Fischell, Feb. 24). Since then, David has established himself working independently and has successfully introduced a wide range of medical devices. He has been issued 86 patents for inventions and has published many articles on the topics of telecommunications, cardiology, radiology, and radiation dosimetry. Some of his medical contributions include: arterial access needles, atherectomy catheters, balloon angioplasty catheters, drug pumps, medication infusion sets, devices to prevent post-operative adhesions and other scar tissue formation, transcranial magnetic stimulators for migraine headaches, implantable devices to warn patients of heart attacks and other cardiac events, and his work with responsive neurostimulators for epilepsy and other neurological disorders (zoominfo.com). Dr. Fischell is also very active in medical groups. David is a member of the American Epilepsy Society, the Biomedical Engineering Society, and the American Institute for Medical and Biological Engineering. ( also known as the AAPM) He is also chairman of the Cornell Biomedical Engineering Advisory Council and has served on the Cornell Life Sciences Advisory Board and the Cornell University Council (Cornell.com). Dr. Fischell and his family have founded nine different companies, which include: Afremica Inc., GlucoTec Inc., IsoStent Inc., Medtronic Inc., and Ostial Solutions LLC. Another company that they started is Angel Medical Systems, which is a company that developed implantable heart attack detection and patient alert systems. The Fischell family also invented the world’s most widely used implantable device in the history of medicine - the stent design. This product is sold by another company they founded, named Johnson and Johnson. This stent has been implanted in more than six million people and the company has made more than ten billion dollars from this one product alone. They also founded Neuralieve which is a company that invented implantable devices for patients with migraine headaches (Stuart). All three of the Fischell sons are now successful inventors and have gotten their inspiration from their father, the incredible Dr. Robert Fischell, one of the other inventors on this project. Dr. Robert Fischell first received a degree in physics from Duke University in 1951. He then attended the University of Maryland for applied physics and got his master’s and doctorate degree. Robert then became a professor at John Hopkins University. It was while he was researching there that he read an article about a pacemaker that lasted two years. He knew that this was a medical advancement but also knew he could make one that lasted eternally. He then left teaching at Johns Hopkins and began inventing privately. Robert invented the first rechargeable, implantable pacemaker and he helped in the invention of the first heart defibrillator. Over the years, Robert has received over 200 U.S. patents and was awarded the 1984 Inventor of the Year Award (web.mit.edu.). Dr. Adrian Upton is the third inventor working on the new NeuroPace technology. Dr. Upton got his degree from Cambridge University. He is now the head of neurology and assistant professor of medicine at McMaster University hospital in Ontario, Canada. He is also currently working on a magnetic gun that can cure headaches. Dr. Upton is a part of the Canadian Neurological Society and the Epilepsy Association (zoominfo.com). When I interviewed Dr. Fischell, I asked him why he decided to go into the work he is in now and what motivated him to start working on this new NeuroPace technology. He responded by telling me that he has the brain power and knowledge to invent these medical devices and that he wants to help advance the medical world and also just because he finds inventing so “cool” (Fischell, Feb 24). Dr. Fischell then went on to tell me how he first became involved with the epilepsy project. David was on a flight to Toronto with his father in 1997. The two of them were on their way to have dinner with Dr. Adrian Upton. His father and Dr. Upton were working on a brain pacemaker for epilepsy treatment together in the 70’s and 80’s. Throughout their studies, they could not find a stimulation system for epilepsy. David was immediately intrigued and came up with some good suggestions that could possibly help the project. The three of them then decided to try these new ideas on the old project. Dr. David Fischell told me in the interview that the first step to working on this project was to get a great patent on the new technology and that it took a whole six months to get one. The patent ended up being 120 pages long and started with 200 claims. The inventors then decided to introduce the idea to a company named, a stent company. VC Kleiner Perkins Caufield and Byers loved the idea and funded the initial start of it. There are no governmental NIST grants for this project, although the researchers are working on hopefully getting one soon, for the final presentation of the product. All of the rest of the funding has come from NeuroPace and the main researchers (Fischell, Feb. 24). After the patent was finished and the Fischell’s and Dr. Upton found an agency to fund the project, they asked Ben Pless, the former Vice President of Research and Development at Ventritex, a heart defibrillator company, to run the development program. NeuroPace designated Frank Fischer, the former CEO of Ventritex, as CEO of NeuroPace. Development of the device and expansion of the initial studies took three whole years. The project was then finished and there were fifty-eight clinical trials done. The neurostimulator only really helped seven of the patients though. The inventors realized that each person’s seizure started in different areas of the brain. The inventors then revised the device and believe that the effect of the device keeps getting better and better (Fischell, Feb. 24). There are only two real clinical studies that are now in progress. The results for this study should be followed up in around nine months (NeuroPace.com). David believes that in the end there will be significant value in this project. He says that it may not eliminate seizures completely, but the number of seizures will definitely decrease (Windhover Information, Inc.). Bibliography
Part 3: Impacts What problems could this technology solve? Isabelle Wallstein Epilepsy is described as a seizure disorder. What causes the seizures is when nerves in the brain end up sending impulses that are four times higher than the normal rate that is usually sent. This is why RNS today has the impact that epilepsy has on people. Epilepsy can affect people from a very young age and can be present their whole entire life, other cases being worse than the others. There is not a cure for epilepsy yet but the way that it has been controlled in the past is through medication, not totally stopping seizure but helping reduce them. As stated above there are many symptoms such as dizziness, the feeling of being faint, tired, these all lead up to the main symptom of epilepsy, which is a seizure. RNS is being used to target the seizures before they happen. However the researchers are unsure of exactly where the nerves act up in the brain. Epilepsy affects many different parts of people’s lives, depending on how serious that an individual’s case is. A lot of times people who are diagnosed with epilepsy they have to follow a strict diet to help prevent seizures from happening. RNS would eliminate the need for a special diet. Epilepsy is also found in children, more often than in adults and behavioral and emotional problems are more prevalent. A lot of times the behavioral and emotional problems stems from being embarrassed and not knowing how to cope with epilepsy. When it comes to adults with severe cases of epilepsy they are often unable to drive because of the risk of having a seizure behind the wheel. A seizure could cause an accident and could hurt them and possibly others. RNS gives the feeling of independence back to adults who are unable to drive. Epilepsy affects the neurological parts of the body but it is also emotionally tolling on the individual and their family. If this technology works, what other opportunities will open up? Since researchers are unaware of where the nerves are acting up exactly in the brain that causes problems, and where the RNS should really be placed. When researchers find exactly where the nerves act up it will be a major step towards the cure of epilepsy. It may not be cured fully but it will point the researchers in the direction of targeting the right area of the brain where epilepsy will be able to be controlled. This will also help eliminate medication for epilepsy, which could have an impact on the environment when it comes to the disposal of the medicine containers. Not only will it eliminate the use of medication for epilepsy patients and help make their everyday life a little better. Medication helped reduce the impact of seizures but RNS’s ultimate goal is to eliminate seizures all together. So far studies have shown improvement in how often seizures occur. However it does differ from patient to patient. Is it viable? RNS is still in the very early stages of the development. Each clinical trial the researcher discovers something that will help improve the technology. There is so much more to learn which gives the researchers confidence in the advancement that RNS will make. Right now the main concern that RNS researchers are trying improve on is the battery life of the technology. In some of the very early trials of RNS there was no improvement. As stated before RNS is just getting off to a start and researchers are just starting to encounter useful information such as the battery life problem. Since the earlier trials information has come out that has been proven that the battery life has not been as long lasting as they expected. The battery is snapped onto the part that is attached to the skull. Many people get the information mixed up that every time a battery is to be replaced. The battery is actually replaced by a small incision in the scalp. With some information being mixed up many people are hesitant to participate in the RNS clinical trials because it has been said that every two years the patient will have to have neurosurgery just to replace the battery. How will it help the areas listed above? Harm them? Since RNS is still a very new technology and is has a lot of improvements to make it will have quite the positive and negative impact on the people affected by epilepsy plus the old and new technology. It is going to help epilepsy families, friends, and the patient themselves. RNS is very new so it may have different effects on people and so far there is no guarantee of the long-term effects that it could have on people. How will the technology evolve? When it comes to RNS expanding and developing in the near future it all comes down to the basis of ever other technology improving. Goals may be as follows, making it more efficient, becoming smaller, making the technology more convenient to the patients and accommodating to them. As more trials go on there are going to be improvements made to the technology such as being able to target the exact place that the seizures are caused. Social The technology of RNS will have an impact on how people will live their lives, and help improve their everyday life. There are many forums and blogs online that are to help people who live with epilepsy cope and ask questions about technologies such as RNS and other trials that are developing. There was a specific person that stood out on the website who shared her experience she had with RNS. It was interesting to see how she felt about RNS and how others reacted to it. The young lady refers to it as RNS investigational trial, she is an experienced patient and was providing information for fellow people on the forum that suffer from epilepsy and were interested in the RNS plan. Not only did she share her experience but gave advice to those thinking about it. In the forum she discussed the process of how they put in RNS and explained the parts of where it is exactly put on the skull. During this segment she also cleared up the confusion of how the battery is replaced because that was a topic that many people were very concerned. She was also very honest when it came to addressing the negative parts of the surgeries such as when the cut is made for the battery replacement there is a very high risk that there can be an infection that may occur. Environmental There are a few different areas that RNS will affect environmentally. Looking into medications that epilepsy patients take there are seven very common medications that are prescribed. Felbatol, Neurontin, Lamictal, Topamax, Gabitril, Diastat, and Lyrica are the most common however each of these medications are prescribed for other disorders or diseases such as bipolar disease, shingles, nerve pains, migraines, anxiety, muscle spasms and fibromyalgia. Since RNS specifically targets seizures for epilepsy patients it leaves all these medications that were being shared between epilepsy patients and patients that were diagnosed with other disorders and diseases will be the only ones who will need the medication. It will prevent doubling up patients on the same medication and will in hopes bring down cost to make medication more affordable. RNS will open more opportunities for helping with other diseases and will also prevent the issues of disposing the medications. Impact The RNS is not only going to have an impact on controlling epilepsy but it is also going to have an impact on all of their families. It is also going to have a major impact on what the government will and will not approve as the trials going on.
Part 4: Action Nick Mackie and Mitch Ogren To bring the RNS system technology into the market it will first have to be approved. The RNS system will have to be used on patients in clinical trials in order to fix all the errors that they can, before it is put out on the market. The RNS system must be able to work at the correct time. It must make sure that it can stop a patient from having seizures right before the seizure is about to happen. In order for the RNS system to be approved it has to avoid all the negative effects such as: the system not working at all times, the system not helping the seizures, or even making the seizures worse. If the RNS can overcome these negative effects it could become a successful product. They must also take note if there are short term effects or the possibility of long term effects. There are some side effects of having the stimulator implanted such as the RNS system is “battery operated;” which means over time you would have to come back in and get a replacement battery (NueroPace). Since this product is an alternative rather than a big change it will be much easier for the product to get into the market. If this product was like changing from gasoline powered cars to hydrogen powered cars, it could be very hard to get this product into the market. The RNS system is a new type of treatment that could be very useful for people with epilepsy, because right now there are only a few types of treatment. Some of the types of treatment include: “treatment by an anti-epileptic medication” (NueroPace) and another is epileptic surgery. These treatments do not always work and people may still continue to experience seizures after or during the above treatments. The Food and Drug Administration is responsible for, “regulation and [the] supervising [of] the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics” (wiki). The FDA is the biggest factor for this product. In order for the RNS system to get into the market it will have to be approved by the FDA. Meaning that the FDA is going to regulate this product and other products like it. If the FDA does not approve the RNS system it will not be allowed on the market in the United States. Since the RNS system needs to be surgically implanted in the brain, the FDA is observing the RNS system during the clinical trials, and if the product is effective a very high percentage of the time, it may be used on most all of patients with epilepsy who meet the requirements to have the RNS system implanted. The American Association of Physicists in Medicine known as the AAPM; is an organization of “Scientific, educational, and professional organization of medical physicists” (Wiki). The purpose of the AAPM is to promote physics in medicine and biology to encourage people to pursue fields in Medical Physics. This agency will help the RNS system if the AAPM became involved with the RNS system. The AAPM would make the RNS have a better chance of getting into the market. This agency is out there to help researchers convert the physics of their product into the medicine and biology components that is needed for the perfection of their product. According to Wiki, “The AAPM has established the Medical Physics as its primary scientific and informational journal” (Wiki). The National Resource Center for Health Information Technology could also play a small role in the RNS system. This organization provides, “free educational resources and events where theory and case examples are presented by researchers active in these fields” (wiki). If the NeuroPace organization shared ideas with this global community of researchers than it might find solutions to some of the problems that the RNS system may be facing. NeuroPace is a “Privately-held company” (NeuroPace) this means that the legal parameters are different from those of a public foundation. The privatization of NeuroPace they are, “restricted by the IRS from lobbying themselves” (ncg.org), but there are some ways for the company to get involved with the public. They may use patients if the patients are willing to take the risk. If NeuroPace wants people to use their product, they must have clinical trials with patients; maybe even offer the clinical trial as free since it is for research. Once their product becomes recognizable it will start to generate a bigger name for the company and this in-turn may help more people with epilepsy. In order to take part in the clinical trials of the RNS system you must be between the ages of, “18 and 65,” and must be an “Individual diagnosed with partial onset epilepsy (those that start from one or two areas of the brain) and have an average of three seizures per month that [can] not [be] controlled by taking two or more anti-epileptic medications” (NeuroPace). All clinical trials do involve some kind of risk such as some unknown risks. Regulations have been set that state before the surgery the hospital is to notify you of all the risks involved, exactly what they will be doing, how they are going to perform the surgery, and then you must sign some papers stating that you are willing to take the risk and you have been informed of the consequences. NeuroPace’s brain implantation device to help treat epilepsy is ground-breaking equipment it will pave the way for people with epilepsy. It will help patients to live a much more normal life without seizures. An example of how this has worked for people is such that one case there was a man who led a good life, had a steady job, and was out four-wheeling one weekend when he had an accident. This accident was a very serious one; he recovered except that he now had been diagnosed with epilepsy. It was one of the most serious forms epilepsy refractory epilepsy. Refractory epilepsy is the kind that cannot be treated with drugs or surgery. He had to quit his job, sell his apartment, and move back in with his mother. So that she could take care of him. He was having so many seizures that it became difficult for him to realize that he was having them; he on average had 4-6 a day. (NeuroPace) Brain devices to treat epilepsy that are presently being observed have the offered hope to patients that have epilepsy and who aren’t sufficiently taken care of by anti-epileptic prescription drugs. They may not have the option of epileptic surgery because it is inoperable. Many patients cannot have surgery, mostly because it’s too risky and is unlikely to be helpful in the patient’s road to recovery. Despite treatment with anti-epileptic medications, “40-50% of patients that have epilepsy continue to experience seizures or have medication side effects” (NeuroPace) which may become more distracting than the seizures themselves. This is why NeuroPace’s brain implantation device is great idea and for however many it can help it will be worth it. This device can be controlled. The control is all about how it will be dispersed and the effects that the recipients of the device would face. So far that the FDA is still overseeing most if not all of the clinical trials currently, since NeuroPace’s RNS system has not yet been approved. After approval there will still be experiments on how to make it better, how to lessen the side effects, and criteria for who it will help best. As for current control, right now it has many regulations as discussed above. These heavily regulated conditions that were set forth by agencies such as the FDA and AAPM make sure that us as the patients are getting products that work and will not harm us instead of helping us. When looking at the NeuroPace’s RNS system the idea of an undergrad student making suggestions on ways to make the overall system better by minimizing the negative effects and maximizing the positive effects is the idea of a perfect cure to epilepsy. A device that is implanted, with no maintenance required. A device that is a perfect solution to all the forms of epilepsy no if ands or buts about it. Ways for NeuroPace to achieve these solutions would be to find a way for the device once implanted to run off the electrical energy given off by the brain and work like a capacitor storing energy until it notices a seizure and then discharging the energy to correct the seizure. Have the implantation device be able to wireless charge while the patient sleeps, say a wall plug that transmits electric power to the device wirelessly. (Currently exists) The ability for this device to cure all forms of epilepsy including refractory not just the epilepsy caused by two certain parts of the brain. The global cure makes for one less disease that we have to worry about being the reason for another human’s death. In the end the NeuroPace’s RNS system shows promising results for some forms of epilepsy, not all but it may become the stepping stone for humanity to be one level closer to understanding the human brain. The device may pave the way for other devices that could cure other brain defects, or brain diseases. The world will have to wait and see. Bibliography
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