Category Archives: Neuroscience

Elon Musk’s brain-computer startup is getting ready to blow your mind – ZDNet

Elon Musk couldn't resist a small joke when he gave the world a first look at Neuralink, thebrain-computer interface (BCI) projectthat he's been working on for the past two years. "I think it's going to blow your minds," he said.

The aim of his startup is to develop technology to tackle neurological problems, from damage caused by brain or spine trauma to the type of memory problems that can become more common in people as they age. The idea is to solve these problems with an implantable digital device that can interpret, and possibly alter, the electrical signals made by neurons in the brain.

"If you can correct these signals you can solve everything from memory loss, hearing loss, blindness, paralysis depression, insomnia, extreme pain, seizures, anxiety, addiction, strokes, brain damage; these can all be solved with an implantable neural link," Musk said at the demonstration of the technology, which also unexpectedly featured live pigs that had actually been implanted with the company's technology.

SEE: Building the bionic brain (free PDF) (TechRepublic)

So isNeuralink as revolutionary as the hype might suggest?

The demo, led by Musk and streamed earlier this month, was the first major update on Neuralink's development since last summer. Musk used the demo to show off the latest iteration of the company's hardware: a small, circular device that attaches to the surface of the brain, gathering data from the cortex and passing it on to external computing systems for analysis.

The system was demonstrated in situ in a pig, gathering data on the animal's neural activity when its snout touched something, and creating a visual representation of that information.

But for all the excitement of what Musk also called the equivalent of "a Fitbit in your skull" (including a minor hitch when the pig became camera shy) all the technology concepts showcased during the demo had been seen elsewhere before now. Several different types of working brain-computer interfaces already exist, gathering data on electrical signals from the user's brain and translating them into data that can be interpreted by machines.

And while Neuralink has yet to implant any of its devices into human subjects, a number of research laboratories have done just that -- to date, a handful of individuals have been fitted with functioning brain-computer interface devices. Typically, they are people who have suffered a spinal injury that's left them paralysed, and who use BCIs help them regain some of that lost function. (One notable user has already been able to recover enough movement in his hands to play Guitar Hero.)

"Other than the implementation of the system they built, all of the things they showed are things that have been shown in the past," neural engineer Edoardo d'Anna, a postdoctoral associate in the Department of Physical Medicine and Rehabilitation at the University of Pittsburgh, tells ZDNet. "So from a scientific point of view, there was nothing novel in that sense." Musk's achievement is instead in building something that is starting to resemble a product that might actually help real patients, rather than a research project -- the stage many other BCIs are currently at.

And that's not the only difference between Neuralink's implementation of a brain-computer interface and those now used elsewhere.

While many current BCIs often involve wired systems, Musk's uses Bluetooth Low Energy to communicate wirelessly. Traditional BCIs use arrays that integrate with the brain using rigid electrodes; Neuralink uses flexible threads. Usually, BCIs leave their users with a box of hardware that sits outside the skull; the Neuralink shouldn't be visible externally. Most research-BCI hardware is implanted by a human neurosurgeon; Neuralink has a robot to do most of the same surgical heavy-lifting.

"They've done a very nice job of the engineering," says Professor Andrew Jackson, professor of neural interfaces at Newcastle University. "They've made progress in all the areas where you would expect a well-resourced, well-funded tech company to make progress. That means things like miniaturising electronics, making things low power off a battery, getting things to operate wirelessly.

"It's a bit unfair to say, but to some extent, these are low-hanging fruit for a big investment from a Silicon Valley tech company, because traditionally a lot of the technology that has been used in neuroscience has been done on a much smaller budget than this, and so things haven't always been kind of optimised to the same level that you are used to in that consumer electronics world," he says.

While the Neuralink demonstration may not have come loaded with never-before-seen technology, it does serve as an illustration of how the technology is progressing towards commercialisation.

"I think the bigger question is what are the new things that can be done with this technology? I think that's to some extent a more interesting question," says Jackson. It's also a question that Musk isn't short of answers to.

SEE: Mind-controlled drones and robots: How thought-reading tech will change the face of warfare

Most BCI work currently ongoing falls into two camps: either it's looking at making consumer-grade, non-invasive kit that could ultimately offer a way of interacting with devices like smartphones -- UIs based on thoughts rather than key presses or voice commands -- or medical-grade systems to help people with brain or spinal injuries overcome paralysis. Musk has far broader aims for his BCI, however. The demo offered the possibility of curing numerous medical conditions, as well as more futuristic aims from telepathically summoning a Tesla to downloading your consciousness and being able to download memories.

Achieving those aims would need a whole new set of functionality to be included in the Neuralink device, and the surgical robot would need to learn new techniques. For example, the current Neuralink sits on the surface of the brain, while some of the longer-term uses of the device Musk touted would mean it would need access to the deeper structures of the brain. Hooking up electronics to deep-brain structures has already been done -- deep-brain stimulation is already used for treating conditions such as Parkinson's -- but it's something of a blunt instrument. Doing something like Musk is proposing would need a much more subtle approach, and not one we've seen discussed by the company yet. It would also require Neuralink to stimulate the brain (sending data into the brain, rather than reading information from it), though there's been no discussion of any stimulation technology from the company so far.

Some of the more long-term, almost sci-fi, visions for Neuralink would also mean addressing some of the black holes in our knowledge of certain areas of neuroscience. Playing back memories and similar applications would first need us to have a better understanding of what memory is and which bits of the brain are involved -- scientists have a good idea, but there's no consensus on whether we know all the pieces (and it all gets more complicated when you start thinking about different types of memory -- remembering your last holiday, how to play the piano, or a list of the Queens and Kings of England by date all live in different brain regions).

"The short-term goal that they talked about of impacting someone who's paralysed and giving them control over a cursor and keyboard or something like that, that is something we know how to do. There's no doubt you can build a product like that, that is totally achievable," says d'Anna. But he says the long-term ideas like capturing your memories and replaying them are something we know very little about. "There's significant gaps in our scientific understanding that needs to be addressed before we can even talk about doing them," he adds.

Does that mean such ideas might be held up by the need for more neuroscience research? Dr Tennore Ramesh, non-clinical lecturer at the University of Sheffield's Department of Neuroscience, believes that AI could enable some of Neuralink's long-term goals, whether we come to understand the neuroscience behind them or not.

SEE: Human meets AI: Intel Labs team pushes at the boundaries of human-machine interaction with deep learning

Treating it as if it's a neuroscience problem "is the wrong way of thinking. It's actually an engineering problem," he says. "The neurons are sending information in bits -- it's almost like a computer program. Of course, it's more complicated than that but, especially with the advent of artificial intelligence and things like that, I think it is pretty feasible," he says.

"In terms of using AI for solving this, though, does it mean that we'll understand how the brain functions? Probably not, because many of these AIs are basically black boxes, but it doesn't mean that we can't put them to use or utilise whatever functionality they provide. So from that point of view, maybe we may not understand the neuroscience very much, but it doesn't mean that we can't make a product that can do those things," Ramesh says.

Either way, the function of setting goals for the Neuralink that outstrip current scientific and engineering capabilities not only gives scientists a bold vision to aim for, but it also generates hype and interest in the company -- unlike the researchers who have worked on BCIs in labs, Musk ultimately has to turn a profit, and that's something he can only do if he can convince the world that Neuralink is as much a consumer device as it is a medical one.

That also means convincing thousands of average people with no health conditions to undergo brain surgery. For most, the idea of having a chunk of skull bored out just to a get Fitbit installed is going to seem outrageous -- the one on their wrist works fine, thanks -- but replaying memories, downloading consciousness or merging with AI offers buyers the prospect of cheating death in an oblique way. That prospect could be decades away, at least, but perhaps in the long-term, the messaging of 'get a neural interface, avoid mortality' might be persuasive to many.

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Elon Musk's brain-computer startup is getting ready to blow your mind - ZDNet

Chan Zuckerberg Initiative awards Yale researchers with grants to study neurodegeneration – Yale Daily News

Yale News

Three Yale researchers have been awarded grants by the Chan Zuckerberg Initiative, or CZI, to research neurodegenerative diseases disorders characterized by the molecular unraveling of the central nervous system, including Alzheimers and Parkinsons diseases.

The three researchers are among 30 pairs of scientists being funded by the initiative to conduct research as part of the Neurodegeneration Challenge Network, or NDCN, which aims to connect professionals from different disciplines and to encourage collaboration between more experienced scientists and those who are at earlier stages of their careers. As such, neuroscience professor Pietro De Camilli and assistant professor of cellular and molecular physiology Hongying Shen GRD 13 will be joining forces on a project that studies how dysfunction in the metabolism of mitochondria and lipid transport proteins might instigate neurodegenerative disorders. Elsewhere at the medical school, associate professor of genetics and neuroscience Marc Hammarlund will collaborate with Gulcin Pekkurnaz, assistant professor of neurobiology at the University of California, San Diego, to explore pathways governing energy balance in healthy neurons and how defects within them can lead to these illnesses.

I was surprised [to receive this grant] because the CZI awards are usually highly competitive, Shen wrote in an email to the News. I was very delighted that I can be part of [this] collaborative, science community.

According to the CZI website, awardees were selected based on the scientific quality of their teams, the transformative potential of their proposals and the possible outcomes that they could ignite. Pekkurnaz, who echoed Shens surprise, added that the grant was pivotal in bringing their scientific plans into fruition.

We all can have great ideas, Pekkurnaz wrote. But without the funding support, they just stay as dreams.

The CZI was co-founded in 2015 by pediatrician Priscilla Chan and Facebook CEO Mark Zuckerberg. The initiative focuses on four core areas: education, social justice, science and community initiatives. According to their website, the initiative was established to promote collaboration and community-driven solutions for different kinds of challenges, including the eradication of diseases. When it comes to neurodegenerative disorders, the fact that there is currently no effective cure makes them a top scientific priority.

While there has been significant investment in neurodegenerative disease research, our understanding of the underlying cellular mechanisms and basic biology of most of these disorders is limited, the CZI website reads. The goal of the Neurodegeneration Challenge Network is to bring together outstanding, innovative, forward-thinking scientists from different disciplines, into a collaborative network to work together on questions related to the basic cell biological mechanisms of neurodegeneration in the context of human disease biology.

Even though the three Yale-associated research projects have slightly different focuses, their interests are all fundamentally related to the mitochondria little structures within cells that play a fundamental role in generating the energy that sustains life.

According to De Camilli, in contrast to other cellular components, mitochondria do not dialogue with surrounding structures through membrane trafficking a process of biochemical signaling that relies on tiny sacs called vesicles. Instead, they retain a certain degree of autonomy. This is due to their evolution from bacteria that invaded cells billions of years ago and eventually became the mitochondria we are familiar with today.

Even though mitochondria function somewhat independently from the other parts of the cell, De Camilli said they are still able to sustain constant communication with other cell structures, especially with the endoplasmic reticulum a network of membranes that is involved in the production of proteins and lipids. This observation sparked his interest in the mechanisms that enable this intricate interaction between these organelles.

I am studying the role of proteins implicated in this cross-talk, and more specifically proteins that tether the ER to mitochondria and mediate exchange of lipids between the two organelles, he said.

According to De Camilli, it is important to study mitochondrial function within the context of neurodegenerative diseases because defects in mitochondria have been linked to cell degeneration and death.

In most tissues, cell death can be compensated by cell renewal, De Camilli wrote. Neurons, however, last all life, and if they die they cannot be renewed.

Knowing that mitochondrial defects can culminate in the death of brain cells raises the question of how they become dysfunctional in the first place. A better understanding of the mechanism by which mitochondria break down would help paint a clearer picture of how neurodegenerative disorders arise.

Mitochondrial deterioration is the hallmark of aging and age-related neurodegeneration, Shen wrote to the News. It would be of great importance to dissect the exact mitochondrial perturbations and the metabolic pathways that would eventually lead to [neurodegenerative] diseases.

According to Shen, even though human genes code for different metabolic enzymes, our primitive understanding of them is a testament to the insufficient attention that has been placed on unpacking their biological role in disease development.

Building upon evidence that has shown that mutations affecting lipid metabolism may be connected to neurodegenerative disease, Shen hopes to shed light on how lipids are metabolized, regulated and distributed within the cell.

Hammarlund and Pekkurnaz, the other Yale-associated duo that has been granted an award, will also research how mitochondrial failure is linked to neurodegeneration through a different lens. Through the use of mouse and invertebrate systems, they will try to understand the pathways that maintain constant energy levels in typical neurons to shed light on how defective energy balance can contribute to neurodegeneration.

A better understanding of how neurons regulate their spatiotemporal energy balance will help us discover how they become faulty in neurodegenerative diseases, Pekkurnaz wrote. This project focuses on in vivo cell-biological cross-species studies, and such studies have the best potential to identify mechanisms that function outside the laboratory in human health and disease.

Pekkurnazs lab at UC San Diego focuses on the different roles played by mitochondria on many cell types. Despite their nickname as the powerhouse of the cell, mitochondria can carry out other cell-specific functions too, including stabilizing the concentration of calcium ions within cells and influencing neurotransmitter metabolism. Researchers in Pekkurnazs lab use interdisciplinary approaches to study the metabolic processes of the cell in typical and atypical conditions.

Hammarlunds research, on the other hand, focuses on neurons themselves. He studies how neurons decide their fate, in addition to neuronal circuits and axon regeneration, and uses these mechanisms to understand how they come into play during neurodegeneration.

In both collaborations, scientists will be leveraging their own expertise and experience to collaboratively uncover different pieces of the neurodegeneration puzzle.

According to the Burke Neurological Institute, somebody in the United States develops Alzheimers disease every 65 seconds.

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Chan Zuckerberg Initiative awards Yale researchers with grants to study neurodegeneration - Yale Daily News

Cerevel Therapeutics to Present at the Morgan Stanley 18th Annual Global Healthcare Conference – Business Wire

BOSTON--(BUSINESS WIRE)--Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced Chairperson and Chief Executive Officer Tony Coles, M.D., will participate in a fireside chat at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16, 2020 at 9:30 a.m. EDT.

The conference will be held virtually and a live webcast of the event is accessible here. A replay will be available in the same section of the companys website for approximately 90 days.

About Cerevel TherapeuticsCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company seeks to unlock the science surrounding new treatment opportunities through understanding the neurocircuitry of neuroscience diseases and associated symptoms. Cerevel Therapeutics has a diversified pipeline comprising five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, epilepsy, Parkinsons disease, and substance use disorder. Headquartered in Boston, Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations or potential acquisitions. For more information, visit http://www.cerevel.com.

Special Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: may, will, could, would, should, expect, intend, plan, anticipate, believe, estimate, predict, project, potential, continue, ongoing or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the proposed business combination, including the timing and structure of the transaction, the proceeds of the transaction, the initial market capitalization of the Combined Company and the benefits of the transaction, as well as statements about the potential attributes and benefits of Cerevel Therapeutics product candidates and the format and timing of Cerevel Therapeutics product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, the ability to complete the business combination due to the failure to obtain approval from Arya IIs shareholders or satisfy other closing conditions in the business combination agreement, the occurrence of any event that could give rise to the termination of the business combination agreement, the ability to recognize the anticipated benefits of the business combination and other risks and uncertainties, including those to be included under the header Risk Factors in the registration statement on Form S-4 to be filed by Arya II with the SEC and those included under the header Risk Factors in the final prospectus of Arya II related to its initial public offering. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

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Cerevel Therapeutics to Present at the Morgan Stanley 18th Annual Global Healthcare Conference - Business Wire

NIH public-private partnership to advance early interventions for schizophrenia – National Institutes of Health

News Release

Tuesday, September 15, 2020

Effort is part of the Accelerating Medicines Partnership to promote development of effective, targeted treatments.

The National Institutes of Health is launching a new public-private partnership to meet the urgent need for early therapeutic interventions for people at risk of developing schizophrenia. Part of the Accelerating Medicines Partnership (AMP), AMP Schizophrenia (SCZ) brings together NIH, the U.S. Food and Drug Administration and multiple non-profit and private organizations. These partners will work toward the shared mission of discovering promising biological markers that can help identify those at risk of developing schizophrenia as early as possible, track the progression of symptoms and other outcomes and define targets for treatment development.

We know that with most brain diseases, early interventions before the onset of symptoms improve long-term outcomes, said NIH Director Francis S. Collins, M.D., Ph.D. Through research weve identified clinical and biological markers for schizophrenia, but we need to translate this knowledge into early interventions to make a meaningful difference in the lives of people at risk for this debilitating disease. AMP Schizophrenia aims to be that bridge.

Schizophrenia is a serious mental illness and is one of the top-15 causes of disability worldwide. The disorder is characterized by alterations to a persons thoughts, feelings and behaviors, which can include a loss of contact with reality known as psychosis. These symptoms typically emerge in adolescence or early adulthood and, if untreated, can be persistent and disabling, interfering with a persons ability to engage in typical school, work and social activities. Individuals with schizophrenia often experience a delay between diagnosis and the start of treatmentranging from one to three yearswhich is often associated with poorer response to treatment and significantly worse long-term outcomes. Particularly for individuals at clinical high risk for psychosis, detecting and intervening before it develops could attenuate, postpone or even prevent the transition to psychosis and improve individuals clinical and functional outcomes.

AMP SCZ aims to develop measures that further define early stages of risk and predict the likelihood of progression to psychosis and other outcomes. Such tools will enable clinical trials to test new pharmacologic interventions that may prevent the onset of psychosis.

AMP SCZ private and non-profit partners include the American Psychiatric Association Foundation, Washington, D.C.; Boehringer Ingelheim Pharmaceuticals Inc., Ingelheim, Germany and Ridgefield, Connecticut; Janssen Research & Development LLC, Raritan, New Jersey; National Alliance on Mental Illness, Arlington, Virginia; One Mind, Rutherford, California; Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey; and Wellcome, London. (See what the partner organizations are saying about AMP SCZ). Combined, these organizations will invest a total of $16.5 million over five years through the Foundation for the National Institutes of Health (FNIH), a non-profit organization,which manages the project. Partner funds, including designated funds from Wellcome, will support, among other efforts, an international research network focused on clinical high-risk populations to ensure that research results are applicable to global clinical trials and extend the reach and impact of the project.

NIHs National Institute of Mental Health (NIMH) expects to contribute $82.5 million over five years, pending availability of funds. Additionally, FDA will be a critical partner in providing regulatory guidance on biological markers of disease progression, outcome measures and endpoints for clinical trials.

The AMP Schizophrenia initiative furthers NIMHs ongoing commitment to research improving the lives of people with early psychosis and schizophrenia, said Joshua A. Gordon, M.D., Ph.D., director of NIMH. This innovative partnership is an exciting opportunity to accelerate research that will spur new pharmacologic approaches to early intervention, leading to positive impacts in the lives of patients with schizophrenia.

A core component of AMP SCZ is establishing a research network focused on individuals who are at clinical high risk, identifying biological markers, clinical endpoints and other measures that predict disease trajectory and outcomes for this group. The initiative will also establish a data center to allow researchers to integrate and analyze data from new and existing clinical high-risk cohorts, with all data and analyses made publicly available through the NIMH Data Archive. Findings from these studies will enable researchers to develop algorithms that predict the course of illness for clinical high-risk individuals, allowing for early intervention and testing of treatments that may prevent the development of schizophrenia and reduce the impact of clinical high risk.

Through this AMP Schizophrenia initiative, we will bring together newly collected data from more than 1,000 clinical high-risk participants within the research networks as well as harmonize data from key research projects through the data center and NIMH Data Archive infrastructure, said Linda Brady, Ph.D., director of the NIMH Division of Neuroscience and Basic Behavioral Science and co-lead for the AMP SCZ technical working group. The partnership and open data sharing are an unprecedented example of collaborative science in schizophrenia. AMP SCZ adds to ongoing NIMH initiatives focused on early detection and intervention in schizophrenia, such as the Early Psychosis Intervention Network (EPINET).

AMP SCZ marks the first AMP initiative focused on a neuropsychiatric disorder and the fifth AMP initiative overall. Ongoing AMP projects bring together scientific talent and financial resources from academia, industry, philanthropy, and government, andfocus on improving the productivity of therapeutic development for Parkinsons disease (PD), Alzheimers disease (AD), type 2 diabetes (T2D), and the autoimmune disorders rheumatoid arthritis and systemic lupus erythematosus (RA/Lupus). Since its launch in February 2014, AMP established new scientific standards for studying the cells associated with lupus and RA. AMP also established knowledge portals in diabetes, Parkinsons diseaseand Alzheimers disease, allowing researchers access to robust data sets that enable unprecedented large-scale analyses.

Meaningful progress in discovering effective interventions for those at risk for schizophrenia is imperative, and it requires a wide range of expert perspectives working in harmony toward this common goal, said Eline Appelmans, M.D., M.P.H., scientific program manager in neuroscience at FNIH. The FNIH is proud to convene the key scientific players that will galvanize progress that makes a difference in the lives of patients.

About the Foundation for the National Institutes of Health: The Foundation for the National Institutes of Health (FNIH) creates and manages alliances with public and private institutions in support of the mission of the NIH. The FNIH works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, please visitfnih.org.

About the National Institute of Mental Health (NIMH):The mission of theNIMHis to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visitwww.nimh.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH public-private partnership to advance early interventions for schizophrenia - National Institutes of Health

A Real-World Study of Dexamethasone Implant in Treatment-Nave Pa | OPTH – Dove Medical Press

Maria Vadal,1,2 Valentina Sunseri Trapani,1 Giulia Guarrasi,1 Nicasio Ventura,1 Massimo Castellucci,1 Salvatore Cillino1

1Biomedicine, Neuroscience and Advanced Diagnostic Department, University of Palermo, Palermo, Italy; 2IEMEST, Euro-Mediterranean Institute of Science and Technology, Palermo, Italy

Correspondence: Maria VadalBiomedicine, Neuroscience and Advanced Diagnostic (BIND) Department, Ophthalmology Institute, University of Palermo, Palermo 90127, ItalyTel +39 091 6553909Email maria.vadala@unipa.it

Purpose: There has been an increasing clinical interest in specific retinal parameters as non-invasive biomarkers of retinal inflammation in diabetic macular edema (DME) that have been shown to have prognostic value, such as hyperreflective retinal fields (HRFs) and subfoveal neuroretinal detachment (SND).Methods: We conducted a prospective, non-comparative study of treatment-nave patients with DME to evaluate the efficacy of a Pro Re Nata (PRN) regimen of intravitreal dexamethasone implant 0.7 mg (DexI, Ozurdex). After administration, patients underwent subsequent injections according to PRN criteria in case of edema relapse, but not earlier than 4 months after the previous treatment. Patients were evaluated at baseline, within 15 days of injection, and every month thereafter. During all visits, best-corrected visual acuity (BCVA) was recorded; central retinal thickness (CRT), type of edema, presence of SND, and presence and number of HRFs were evaluated using swept-source optical coherence tomography (SS-OCT) 3D. Treatment outcome was defined as changes in BCVA, CRT, SND and HRFs at 12 (T12) and 24 (T24) months compared with baseline (T0).Results: The study enrolled 24 eyes of 18 patients. The mean duration of follow-up was 18 6.6 months; for all eyes, T12 data were available, while follow-up reached T24 for 12 eyes. BCVA improved significantly and CRT decreased significantly during treatment; the edema was no longer detectable in 13/24 eyes at T12 and 8/12 eyes at T24. No patient presented SND at T12 and T24, and the mean number of HRFs decreased significantly during treatment. Results with CRT and HRFs correlated with BCVA at 12 and 24 months. No significant adverse events were observed.Conclusion: In patients with DME, the intravitreal dexamethasone implant was effective and safe in improving both functional and tomographic parameters. This result is consistent with improvement in biomarkers of inflammation.

Keywords: dexamethasone implant, diabetic macular edema, intravitreal implants, Ozurdex, real-world, inflammation

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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A Real-World Study of Dexamethasone Implant in Treatment-Nave Pa | OPTH - Dove Medical Press

Slovak company on positive results of COVID-19 vaccine – The Slovak Spectator

The tests have been carried out on mice so far. Testing on people can start at the end of this year.

The Slovak Spectator has decided to make all the articles on the special measures, statistics and basic information about the coronavirus available to everyone. If you appreciate our work and would like to support good journalism, please buy our subscription. We believe this is an issue where accurate and fact-based information is important for people to cope.

Slovak biotechnology company Axon Neuroscience has reported positive preclinical results of its vaccine against the novel coronavirus.

It tested the peptide vaccine on mice, reporting no adverse side effects, the TASR newswire reported.

The results have been successful in several key points. The vaccinated mice generated a big amount of antibodies in their blood. These antibodies focused on the specific, vulnerable part of the protein that enables the virus to infect cells and then reproduce.

The antibodies effectively neutralised the living coronavirus, according to its creators. The neutralisation was tested by an experiment in which they monitored whether the blood of the vaccinated mice can prevent the infection of cells by the virus, TASR reported.

They identified the weakest points of the SARS-CoV-2 virus and navigated the immunity system to these small areas with the length of about 20 amino acids, thanks to which they managed to eliminate the virus infection, said Norbert ilka, scientific director of Axon Neuroscience.

The results from the virus neutralisation test showed our strategy was successful, he added, as quoted by TASR.

The positive results imply that it may be possible to use the vaccine to fight the coronavirus.

We will soon start testing people so that we can introduce a vaccine without compromises when it comes to safety and effectiveness, said Michal Fresser, executive director of Axon Neuroscience, as quoted by TASR.

The first clinical tests on people can start in the final quarter of this year, he added.

14. Sep 2020 at 11:51 |Compiled by Spectator staff

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Slovak company on positive results of COVID-19 vaccine - The Slovak Spectator

Micron-thick NET probes help record neuronal activity in different parts of the brain – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Sep 15 2020

Rice University engineers will gain a better understanding of brain activity over time with the support of the National Institutes of Health.

The agency has awarded a four-year grant of $4.15 million to Chong Xie of the Brown School of Engineering's Neuroengineering Initiative to maximize the use of devices based on the flexible nanoelectronic thread (NET) he has developed. The information they gather could be critical to the future treatment of neurological disease.

The biocompatible probes have the unique ability to stably record electrical information from individual neurons.

They will be designed to record neuronal activity in different parts of the brain to help researchers understand complex, three-dimensional patterns that occur on a millisecond time scale but evolve over days, months and years.

Xie said current probes are often rigid electrodes that lack the necessary lifetimes to collect dynamic information over the long term and are ill-suited to use with imaging techniques.

Micron-thick NET probes, each with 128 contacts, can be implanted in various regions of the brain by attaching them to more rigid tungsten wires of the same size with a water-soluble adhesive. When the glue melts, the wires are withdrawn, leaving the probes in place.

"In order to do this at a large scale so we can analyze neural dynamics, we do need to get closer to the scale, to a certain extent, of the nervous system, which we know is huge," said Xie, an associate professor of electrical and computer engineering and of bioengineering who joined Rice this year.

"This project is designed to extend the current spatiotemporal scales we have in neuroscience studies by making smaller and more flexible electrodes and with longer-lasting recording capabilities," he said. "We've also engaged a neuroscientist in this project -- co-principal investigator Loren Frank of the University of California, San Francisco -- so we have direct knowledge of what these scientists need."

The probes enabled a study published earlier this year by his collaborator, Lan Luan, who used the technology to discover that blood flow recovers faster than the brain in microscopic strokes. In that study, NET probes were combined with optical lines that measured blood flow by laser speckle patterns for as long as eight weeks.

Our electrodes in that study were really limited to just a few dozen. But with the new technology development, we're hoping to be able to test these bi-model types of measurements with larger-scale recordings in different regions of the brain."

Lan Luan, Study Co-Investigator and Assistant Professor, Department of Electrical and Computer Engineering, Rice University

The researchers plan to optimize NET probes to gather high-density information in animal models for various brain regions and species.

The current technology is just a start, according to Xie. "We have parallel efforts to design electrodes that may eventually be used in humans," he said.

Alex Huk of the University of Texas at Austin and Mattias Karlsson at SpikeGadgets Inc. are also co-investigators on the project. The grant is being administered by the National Institute of Neurological Disorders and Stroke.

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Journal reference:

He, F., et al. (2020) Multimodal mapping of neural activity and cerebral blood flow reveals long-lasting neurovascular dissociations after small-scale strokes. Science Advances. doi.org/10.1126/sciadv.aba1933.

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Micron-thick NET probes help record neuronal activity in different parts of the brain - News-Medical.Net

AbbVie to Present New Data From 18 Abstracts at the International Congress of Parkinson’s Disease and Movement Disorders – Cherokee Tribune Ledger…

NORTH CHICAGO, Ill., Sept. 11, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present results from several studies, including the DYSCOVER study evaluating the efficacy of DUODOPA (levodopa/carbidopa intestinal gel) on the duration and severity of dyskinesia in patients with advanced Parkinson's disease (PD), at the 2020 International Congress of Parkinson's Disease and Movement Disorders Virtual Congress, September 12-16. In total, 18 abstracts will be presented, including an overview of the pivotal Phase 3 study design for the investigational medicine ABBV-951 in patients with advanced PD, several studies evaluating the economic burden of PD, as well new and updated data evaluating AbbVie's neuroscience portfolio and pipeline.

The 12-week DYSCOVER study is the first randomized clinical trial comparing the efficacy of DUODOPA to optimized medical treatment (OMT) on dyskinesia in advanced PD patients using the Unified Dyskinesia Rating Scale (UDysRS), which measures all aspects of dyskinesia with a comprehensive score as the primary endpoint.

The study design for the multi-country, open-label, single arm, 52-week pivotal phase 3 study of ABBV-951 (foscarbidopa/foslevodopa), a subcutaneous delivery of levodopa/carbidopa being investigated for the treatment of advanced PD, will also be presented. The study is evaluating the local and systemic safety and tolerability of ABBV-951 delivered as a continuous, all-day subcutaneous infusion via an external pump for up to 52 weeks in people with advanced PD. The study is in process and estimated to conclude in late 2021.

"At AbbVie, we are resolute in our commitment to address the unmet needs of people living with neurologic diseases through new and innovative solutions," said Michael Gold, MD, Vice President, Neuroscience Development. "In the face of uncertainty and the unknown, we are determined to preserve personhood. We look forward to participating in the MDS 2020 Virtual Congress and sharing our latest research with scientists and healthcare professionals from around the globe."

Other data presentations include analyses from several DUODOPA-related studies, including the COSMOS Observational Study, a multi-country, cross-sectional, retrospective, post-marketing observational study that enrolled patients with advanced PD who were treated with DUODOPA for more than 12 months. Also being presented are analyses from the DUOGLOBE study, athree-year global, multicenter, single-arm, non-interventional post-marketing observational study of patients with advanced PD treated with DUODOPA.

Additionally, abstracts demonstrating the prevalence, impact and economic burden of PD will be presented.

About Parkinson's DiseaseMore than 10 million people worldwide are living with Parkinson's disease1, a progressive and chronic movement disordercharacterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.2It is classified as a movement disorder resulting from the loss of dopamine-producing brain cells.3The motor symptoms of Parkinson's disease begin when approximately 60-80 percent of the dopamine-producing cells in the brain are lost and symptoms continue to worsen slowly over the course of time.4While there is no known cure for the disease, there are treatments available to help reduce symptoms.5

As Parkinson's disease progresses, patients can experience fluctuations from an "on state" to an "offstate," during which they are slower and stiffer and experience more difficulty moving. Patients can also experience dyskinesias (involuntary movements). Dyskinesia is among the most troublesome symptoms of the disease with approximately 50 percent of patients presenting with dyskinesia four to five years after initiation of treatment and approximately 90 percent of patients presenting with dyskinesia after nine years.6

DUODOPA (levodopa/carbidopa intestinal gel) EU IndicationDUODOPA is indicated for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson's medicinal products have not given satisfactory results.

Important DUODOPA EU Safety InformationDUODOPA is contraindicated in patients with hypersensitivity to levodopa, carbidopa or any of the excipients, narrow-angle glaucoma, severe heart failure, severe cardiac arrhythmia, acute stroke, selective type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing's syndrome), and suspicious skin lesions or history of melanoma.

Some warnings and precautions include the following: device and procedure-related complications, sudden onset of sleep: caution should be exercised when driving and operating machines. Caution in: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. Patients with past or current psychosis should be treated with caution. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with DUODOPA. Patients with Parkinson's disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using DUODOPA. DUODOPA is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with DUODOPA.

The most common adverse reactionwas complication of device insertion.

The very common ( 10%) and common (1% to < 10%) device and procedure-related adverse reactions reported in clinical trials includedabdominal discomfort, abdominal pain, peritonitis, pneumoperitoneum postoperative wound infection, incisional cellulitis, excessive granulation tissue, device dislocation, device occlusion, complications of device insertion, incision site erythema, post-procedural discharge, stoma complication, incision site pain, postoperative Ileus, post-procedural complication, post-procedural discomfort and post-procedural hemorrhage.

Most of these adverse reactions were reported early in the studies, subsequent to the percutaneous endoscopic gastrostomy procedure, occurring during the first 28 days.

Drug-related undesirable effects that occur frequently with the DUODOPA system include nausea and dyskinesia.

This is not a complete summary of all safety information. See DUODOPA full summary of product characteristics (SmPC) at http://www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About ABBV-951ABBV-951 is a subcutaneous delivery of levodopa/carbidopa being investigated for the treatment of advanced Parkinson's disease.

About AbbVie in Neuroscience At AbbVie, our commitment to preserve the personhood of those living with neurologic and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies and a robust pipeline in neurologicand psychiatric disorders, including Alzheimer's disease,bipolar disorder and depression, major depressive disorder, migraine, multiple sclerosis, Parkinson's disease,post-stroke spasticity, schizophrenia, and stroke.

We have a strong investment in neuroscience research, with our Foundational Neuroscience Center inCambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen,Germany, where our research and perseverance in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurologic diseases, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people's lives. For more information, please visitwww.abbvie.com.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie on Twitter,Facebook,Instagram,YouTubeandLinkedIn.

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe,""expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with theSecurities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Parkinson's Foundation. https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=More%20than%2010%20million%20peopleAccessed August 27, 2020.2 The Michael J. Fox Foundation for Parkinson's Research. https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2AccessedAugust 27, 2020.3 The Michael J. Fox Foundation for Parkinson's Research. https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2AccessedAugust 27, 2020.4 National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2020.5 National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research. Accessed August 27, 2020.6 Van Laar T. CNS Drugs. 2003;17:475-489.

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AbbVie to Present New Data From 18 Abstracts at the International Congress of Parkinson's Disease and Movement Disorders - Cherokee Tribune Ledger...

Whats the Frequency, Kenneth? As Information Flows Through Brains Heirarchy, Higher Regions Use Higher-Frequency Waves – SciTechDaily

Study also finds specific frequency bands of brain waves associated with encoding, or inhibiting encoding, of sensory information across the cortex.

To produce your thoughts and actions, your brain processes information in a hierarchy of regions along its surface, or cortex, ranging from lower areas that do basic parsing of incoming sensations to higher executive regions that formulate your plans for employing that newfound knowledge. In a new study, MIT neuroscientists seeking to explain how this organization emerges report two broad trends: In each of three distinct regions, information encoding or its inhibition was associated with a similar tug of war between specific brain wave frequency bands, and the higher a regions status in the hierarchy, the higher the peak frequency of its waves in each of those bands.

By making and analyzing measurements of thousands of neurons and surrounding electric fields in three cortical regions in animals, the teams new study in the Journal of Cognitive Neuroscience provides a unifying view of how brain waves, which are oscillating patterns of the activity of brain cells, may control the flow of information throughout the cortex.

When you look at prior studies you see examples of what we found in many regions, but they are all found in different ways in different experiments, says Earl Miller, the Picower Professor of Neuroscience in The Picower Institute for Learning and Memory at MIT and senior author of the study. We wanted to obtain an overarching picture, so thats what we did. We addressed the question of what does this look like all over the cortex.

Brain waves are oscillating patterns of the activity of brain cells as they process information. A new study finds that different frequency bands are associated with encoding, or not encoding, sensory information. Credit: MIT

Adds co-first author Mikael Lundqvist of Stockholm University, formerly a postdoc at MIT: Many, many studies have looked at how synchronized the phases of a particular frequency are between cortical regions. It has become a field by itself, because synchrony will impact the communication between regions. But arguably even more important would be if regions communicate at different frequencies altogether. Here we find such a systematic shift in preferred frequencies across regions. It may have been suspected by piecing together earlier studies, but as far as I know hasnt been shown directly before. It is a simple, but potentially very fundamental, observation.

The papers other first author is Picower Institute postdoc Andre Bastos.

To make their observations, the team gave animals the task of correctly distinguishing an image they had just seen a simple feat of visual working memory. As the animals played the game, the scientists measured the individual spiking activity of hundreds of neurons in each animal in three regions at the bottom, middle, and top of the tasks cortical hierarchy the visual cortex, the parietal cortex, and the prefrontal cortex. They simultaneously tracked the waves produced by this activity.

Measurements of brain wave power while animals waited to see a new image show distinct peaks in the beta frequency band in each region: About 11 Hz in visual cortex V4, 15 Hz in parietal cortex, and 19 in prefrontal cortex. Credit: Miller Lab/Picower Institute for Learning and Memory

In each region, they found that when an image was either being encoded (when it was first presented) or recalled (when working memory was tested), the power of theta and gamma frequency bands of brain waves would increase in bursts and power in alpha and beta bands would decrease. When the information had to be held in mind, for instance in the period between first sight and the test, theta and gamma power went down and alpha and beta power went up in bursts. This functional push/pull sequence between these frequency bands has been shown in several individual regions, including the motor cortex, Miller said, but not often simultaneously across multiple regions in the course of the same task.

The researchers also observed that the bursts of theta and gamma power were closely associated with neural spikes that encoded information about the images. Alpha and beta power bursts, meanwhile, were anti-correlated with that same spiking activity.

While this rule applied across all three regions, a key difference was that each region employed a distinct peak within each frequency band. While the visual cortex beta band, for instance, peaked at 11 Hz, parietal beta peaked at 15 Hz, and prefrontal beta peaked at 19 Hz. Meanwhile, visual cortex gamma occurred at 65 Hz, parietal gamma topped at 72 Hz, and prefrontal gamma at 80 Hz.

As you move from the back of the brain to the front, all the frequencies get a little higher, Miller says.

While both main trends in the study the inverse relationships between frequency bands and the systematic rise in peak frequencies within each band were both consistently observed and statistically significant, they only show associations with function, not causality. But the researchers said they are consistent with a model in which alpha and beta alternately inhibit, or release, gamma to control the encoding of information a form of top-down control of sensory activity.

Meanwhile, they hypothesize that the systematic increase in peak frequencies up the hierarchy could serve multiple functions. For instance, if waves in each frequency band carry information, then higher regions would sample at a faster frequency to provide more fine-grained sampling of the raw input coming from lower regions. Moreover, faster frequencies are more effective at entraining those same frequencies in other regions, giving higher regions an effective way of controlling activity in lower ones.

The increased frequency in the oscillatory rhythms may help sculpt information flow in the cortex, the authors wrote.

Reference: Preservation and Changes in Oscillatory Dynamics across the Cortical Hierarchy by Mikael Lundqvist, Andr M. Bastos and Earl K. Miller, October 2020, Journal of Cognitive Neuroscience.DOI: 10.1162/jocn_a_01600

The study was supported by the U.S. National Institutes of Health, the Office of Naval Research, The JPB Foundation, the Swedish Research Council, and the Brain and Behavior Research Foundation.

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Whats the Frequency, Kenneth? As Information Flows Through Brains Heirarchy, Higher Regions Use Higher-Frequency Waves - SciTechDaily

Restraint and seclusion regulations are finalized. Now it’s time to prohibit their use. – Virginia Mercury

By Beth Tolley

On Aug. 22, regulations on the use of seclusion and restraint in public elementary and secondary schools in the Commonwealth of Virginia were finalized, with an implementation date of Jan. 1. Virginia now has regulations that legitimize practices that are ineffective, cruel and harmful.

For those unfamiliar with restraint and seclusion, here are the definitions:

Restraint is a personal restriction that immobilizes or reduces the ability of a student to move his or her torso, arms, legs, or head freely. Seclusion is the involuntary confinement of a student alone in a room or area from which the student is physically prevented from leaving.

These regulations make it perfectly acceptable to restrain or seclude students if the requirements set forth in the regulations are met. Five years in the making, advocates were sharply divided about making comments during the 30-day public comment period prior to finalization. Those who had worked so hard to get regulations in place feared that they would be delayed or derailed by comments. Other advocates felt that the regulations didnt provide enough protection to make a substantial impact.

In the end there were no comments submitted. Many advocates recognized the futility of comments that would be addressed by the same agency (Virginia Department of Education) that ignored 123 public comments last year. Both groups of advocates agreed that there were serious flaws in the regulations which would likely not be fixed through additional revisions; legislation with the force of law rather than regulations is necessary.

During the past 20 years, studies have been done by federal agencies, professional organizations and national research institutions. The research indicates that use of these procedures does not keep students and teachers safer, it in fact makes them less safe. Physical injuries up to and including death have occurred. Restraint and seclusion have no therapeutic or educational value. They are traumatizing for the students subjected to these procedures, to the adults administering them and to the children and adults observing their use.

Restraint and seclusion are used in general education and special education schools and settings. They are used in schools where students behaviors are framed as choices, where school cultures emphasize compliance, but school leaders and staff do not differentiate between voluntary and involuntary stress (fight, flight, freeze) behaviors. Failing to differentiate between voluntary and involuntary behaviors results in punishment of students when they need support and compassion.

One of the most important findings from brain, trauma, neuroscience and attachment research during the past 30 years is the recognition of the role unconscious detection of danger, stress and fear play in disruptive behaviors. Unconscious detection of real or perceived danger by the brains regulatory systems shift the brain state to survival mode, setting off a flight, fight or freeze response.

These stress responses are neither voluntary or responsive to a system of rewards and consequences, features all too common in school behavior management systems. The brains of children with trauma histories, mental health concerns, neurodiversity and/or developmental delays are highly sensitized to cues of danger. The lack of differentiation between voluntary behaviors and stress responses may be the biggest factor in the huge disproportionality of students with disabilities who are restrained and secluded.

Use of restraint and seclusion reflect a culture that has not moved into the 21st century, a culture and mindset that holds students accountable for fear-based non-volitional behaviors. Furthermore, schools that use these procedures most likely do not recognize the role of the adults in creating or escalating students fear and subsequent stress responses. As Ron Garrison, former special education teacher and legal expert states, we have to remember that restraint and seclusion are not legitimate interventions; they are forms of torture. They specifically destroy what you need to be building up: safety, trusting relationships and autonomy.

It is incumbent upon teacher and administrator organizations, as well as state departments of education to prioritize education of all educational personnel in the areas of brain development including the impact of toxic stress and trauma; trauma and resilience; state dependent functioning; regulation; emotional contagion; power differentials; and true preventative activities (co-regulation; rhythmic repetitive regulatory activities throughout each day, student/teacher collaborative and proactive solutions).

Educational leaders must advocate for school cultures that embrace and support all children, no matter their race, culture, ability or disability. Schools that have changed their culture and practices to reflect an understanding of the current neuroscience, brain development, child development and trauma science have eliminated the use of restraint and seclusion. And not only has this led to environments that are safer for students and teachers, it has resulted in positive academic results.

It is past time to adopt the Civil Rights Principles for Safe, Healthy, and Inclusive School Climates endorsed by 60 organizations and the 2020 American Bar Association resolution prohibiting the use of restraint and seclusion on students in preschool, primary school, and secondary school.We can and must do better for all our students, teachers and families.

Beth Tolley is the director of educational strategy for theAlliance Against Seclusion and Restraint.She retired from the Virginia Department of Behavioral Health two years ago, where she was the team leader for monitoring and supervision for the Infant and Toddler Connection of Virginia. She lives in Henrico.

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Restraint and seclusion regulations are finalized. Now it's time to prohibit their use. - Virginia Mercury