According to the CDC, over 3.4 million Americans – or 1.2 percent of the U.S. population – suffer from some form of epilepsy. Medication keeps some of these people’s seizures under control. The medications’ side effects, however, often make it difficult to function normally, and at least 30 percent of patients don’t respond to anti-seizure medication at all.
Enter NeuroPace, Inc., a neuro-technology company based in Silicon Valley. It recently concluded a nine-year study on patients suffering from epilepsy using a tech gadget – not medication – to stymie the seizures.
The results? Over the course of the study, 75 percent of epileptic patients had at least a 50 percent reduction in seizures – and 33 percent had at least a 90 percent reduction! In addition, 28 percent had no seizures for over six months and 18 percent had no seizures for over a year. Patients did not report chronic stimulation side effects.
NeuroPace’s neuro-modulation study was the longest and largest for epileptics. The company evaluated 230 patients from 33 epilepsy centers across the United States. In addition to long-term seizure reduction, patients reported having a better quality of life in areas unrelated to epilepsy, and the device’s neural recordings provided doctors with critical information to better understand and, subsequently, treat seizures.
So how exactly does the technology work?
Neurons in the human brain constantly release electrical signals (otherwise known as brain activity). Misfired electrical signals can result in seizures. Anti-seizure medications remove, reduce, or alter excessive electrical activity so that faulty electrical signals aren’t “passed on” to the next batch of neurons, thus reducing the probability of seizures.
In contrast, NeuroPace’s Responsive Neurostimulation (RNS) System uses a computer interface technology device to treat the seizures at their source – and the device only goes into gear when the patient requires it. The RNS System uses a three-pronged approach. First, it detects and responds to a patient’s brain activity. Every patient’s brain is a little different, so doctors tailor the program to each patient’s unique brain activity.
Once programmed, the RNS System monitors a patient’s brainwaves and is ready to provide treatment whenever it detects unusual activity that can lead to a seizure, even if the patient is sleeping. Finally, once unusual brain activity is detected, the device responds with a series of electrical pulses or bursts of stimulation to stop the seizure and normalize the brainwaves before the seizure begins.
The RNS device, which is essentially a neuro-stimulator, is placed on the bone covering the brain. Once installed, it cannot be seen or felt. Tiny wires are positioned on one or two places atop the brain where seizure activity is likely to occur. The RNS System has a remote monitor used by patients to upload his or her data, as well as an RNS tablet and Patient Data Management System to enable doctors to better monitor patients. The device can always be turned off or removed if a patient doesn’t want it anymore.
During the course of the study, NeuroPace upgraded its RNS System. The 2.0 version has a battery life lasting 8.4 years, as opposed to the original’s 3.9 years. The amount of available memory for doctors to review patients’ brainwaves has also doubled.
The RNS System is available in epilepsy centers across the U.S. It is often used in conjunction with medication and is usually covered by insurance.
SOURCE: Article by B. Halperin for JewishPress.com
September 12, 2018: LivaNova PLC announced the first implanted patient and official launch of a global registry to evaluate the use of LivaNova’s Vagus Nerve Stimulation Therapy® (VNS Therapy) System for patients with drug-resistant epilepsy (DRE), which affects nearly one in three people with epilepsy.1 The Comprehensive Outcomes Registry in Subjects with Epilepsy Treated with VNS Therapy (CORE-VNS) study will enroll up to 2,000 patients with five-year follow-up data, yielding one of the largest data sets in the world for DRE patients treated with various generations of VNS Therapy. Data from CORE-VNS will contribute to the body of research related to this disease state and advance the science behind VNS Therapy by evaluating the safety, effectiveness and clinical outcomes for patients.
“By following these patients for five years, we will gain a significant amount of high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for drug-resistant epilepsy”
The registry will include up to 80 sites globally, collecting outcomes in real-world settings by following participating patients for up to five years after treatment begins. Documented clinical outcomes will include seizure frequency, seizure severity, quality of life, quality of sleep, antiepileptic drug use, and seizure-related emergency visits and hospitalizations.
“Many patients with drug-resistant epilepsy have tried numerous treatment options with limited results. The CORE-VNS study will give us a greater understanding of the drug-resistant epilepsy patient population around the world and the role VNS Therapy can play in the overall management of this disease,” said Bryan Olin, LivaNova’s Senior Vice President of Clinical, Quality Assurance and Regulatory Affairs. “Additionally, this study will allow us to evaluate the latest advancements in VNS Therapy, including the capability to track and use real-time patient data to inform treatment.”
Dr. Kore Liow, FACP, FAAN, from the Comprehensive Epilepsy Center at Hawaii Pacific Neuroscience and Clinical Professor at the University of Hawaii John Burns School of Medicine, has enrolled the most patients to date in the CORE-VNS registry in preparation for VNS Therapy implants. “By following these patients for five years, we will gain a significant amount of high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for drug-resistant epilepsy,” said Liow.
VNS Therapy received CE Mark in 1994 and U.S. Food and Drug Administration approval in 1997 as an adjunctive treatment for drug-resistant epilepsy. The system consists of two implantable components: a programmable electronic pulse generator that is connected to a bipolar electrical lead, which sends mild pulses to stimulate the vagus nerve at regular intervals throughout the day.
For more information on VNS Therapy, please visit www.VNSTherapy.com.
To learn more about the study and locations go HERE.
About VNS Therapy for Epilepsy
VNS Therapy is clinically proven safe and effective for the treatment of drug-resistant epilepsy for adults and children. VNS Therapy is designed to prevent seizures before they occur and stop them if they do. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects one in three people with epilepsy. For more information, visit www.VNSTherapy.com or www.VNSTherapy.co.uk.
The witness on the stand says he saw the accused at the scene of the crime. Is he sure? How sure? The jury’s verdict could hinge on that level of certainty.
Many decisions we make every day are influenced by our memories and the confidence we have in them. But very little is known about how we decide whether we can trust a memory or not.
A new Cedars-Sinai study provides some of the answers. Researchers have identified a unique set of neurons in the medial temporal lobe, an area of the brain where memories and memory-based decisions are processed. They show that the activity of these neurons is indicative of the confidence by which a memory will be retrieved. Findings are published in the June 8 online issue of Nature Neuroscience.
“The mechanisms that help us make confidence judgments about a memory-based decision are poorly understood, but we know they are impaired by many different diseases and disorders,” said Ueli Rutishauser, PhD, assistant professor of neurosurgery and director of human neurophysiology research at Cedars-Sinai, the article’s lead author. (more…)
Fycompa has not been approved by the FDA as an add-on therapy for seizures because additional benefit has yet to be proven.
The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive (“add-on”) therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether perampanel offers an added benefit over the appropriate comparator therapy. However, such an added benefit cannot be derived from the new dossier either, as the drug manufacturer did not submit any relevant data for this comparison.
Already in the first dossier assessment in December 2012, there was no proof of an added benefit of perampanel because the manufacturer dossier provided no suitable data. The new assessment was conducted upon application of the manufacturer to the Federal Joint Committee (G-BA), which specifies the appropriate comparator therapy.
Appropriate comparator therapy expanded
Fits that affect only a small part of the brain are called “focal” or “partial seizures”. In this type of fit, the muscle twitches and spasms remain limited to isolated parts of the body. However, such seizures may spread across the whole body and are then referred to as “secondary generalization”. Perampanel is approved as add-on therapy for the treatment of partial seizures with or without secondary generalization in people aged 12 years and older.
The G-BA approved the manufacturer’s application for reassessment of the drug according to AMNOG because the appropriate comparator therapy had to be expanded following the change in the AMNOG Regulation for Early Benefit Assessment of New Pharmaceuticals (in §6 (1), Sentence 2, AM-NutzenV): Originally the more economical comparator therapy had to be chosen if several options were available, preferably a treatment with a fixed price. This regulation was dispensed with in 2013. If the G-BA specifies several options as appropriate comparator therapies, the manufacturer is now free to choose a therapy irrespective of the costs.
CONTINUE READINg AT SOURCE: http://medicalxpress.com/news/2014-08-perampanel-epilepsy-proof-added-benefit.html
New light-sensitive protein enables simpler, more powerful optogenetics
Optogenetics, a technology that allows scientists to control brain activity by shining light on neurons, relies on light-sensitive proteins that can suppress or stimulate electrical signals within cells. This technique requires a light source to be implanted in the brain, where it can reach the cells to be controlled.
MIT engineers have now developed the first light-sensitive molecule that enables neurons to be silenced noninvasively, using a light source outside the skull. This makes it possible to do long-term studies without an implanted light source. The protein, known as Jaws, also allows a larger volume of tissue to be influenced at once.
This noninvasive approach could pave the way to using optogenetics in human patients to treat epilepsy and other neurological disorders, the researchers say, although much more testing and development is needed. Led by Ed Boyden, an associate professor of biological engineering and brain and cognitive sciences at MIT, the researchers described the protein in the June 29 issue of Nature Neuroscience.
Optogenetics, a technique developed over the past 15 years, has become a common laboratory tool for shutting off or stimulating specific types of neurons in the brain, allowing neuroscientists to learn much more about their functions.
The neurons to be studied must be genetically engineered to produce light-sensitive proteins known as opsins, which are channels or pumps that influence electrical activity by controlling the flow of ions in or out of cells. Researchers then insert a light source, such as an optical fiber, into the brain to control the selected neurons.
Such implants can be difficult to insert, however, and can be incompatible with many kinds of experiments, such as studies of development, during which the brain changes size, or of neurodegenerative disorders, during which the implant can interact with brain physiology. In addition, it is difficult to perform long-term studies of chronic diseases with these implants.
Mining nature’s diversity
To find a better alternative, Boyden, graduate student Amy Chuong, and colleagues turned to the natural world. Many microbes and other organisms use opsins to detect light and react to their environment. Most of the natural opsins now used for optogenetics respond best to blue or green light.
Boyden’s team had previously identified two light-sensitive chloride ion pumps that respond to red light, which can penetrate deeper into living tissue. However, these molecules, found in the bacteria Haloarcula marismortui and Haloarcula vallismortis, did not induce a strong enough photocurrent – an electric current in response to light – to be useful in controlling neuron activity.
Chuong set out to improve the photocurrent by looking for relatives of these proteins and testing their electrical activity. She then engineered one of these relatives by making many different mutants. The result of this screen, Jaws, retained its red-light sensitivity but had a much stronger photocurrent – enough to shut down neural activity.
“This exemplifies how the genomic diversity of the natural world can yield powerful reagents that can be of use in biology and neuroscience,” says Boyden, who is a member of MIT’s Media Lab and the McGovern Institute for Brain Research.
Using this opsin, the researchers were able to shut down neuronal activity in the mouse brain with a light source outside the animal’s head. The suppression occurred as deep as 3 millimeters in the brain, and was just as effective as that of existing silencers that rely on other colors of light delivered via conventional invasive illumination.
Working with researchers at the Friedrich Miescher Institute for Biomedical Research in Switzerland, the MIT team also tested Jaws’s ability to restore the light sensitivity of retinal cells called cones. In people with a disease called retinitis pigmentosa, cones slowly atrophy, eventually causing blindness.
Friedrich Miescher Institute scientists Botond Roska and Volker Busskamp have previously shown that some vision can be restored in mice by engineering those cone cells to express light-sensitive proteins. In the new paper, Roska and Busskamp tested the Jaws protein in the mouse retina and found that it more closely resembled the eye’s natural opsins and offered a greater range of light sensitivity, making it potentially more useful for treating retinitis pigmentosa.
This type of noninvasive approach to optogenetics could also represent a step toward developing optogenetic treatments for diseases such as epilepsy, which could be controlled by shutting off misfiring neurons that cause seizures, Boyden says. “Since these molecules come from species other than humans, many studies must be done to evaluate their safety and efficacy in the context of treatment,” he says.
Boyden’s lab is working with many other research groups to further test the Jaws opsin for other applications. The team is also seeking new light-sensitive proteins and is working on high-throughput screening approaches that could speed up the development of such proteins.