Myoclonus

REM sleep behavior disorder, or RBD, is a condition that causes abnormal movements or brief repeated twitching during sleep, and occasional episodes of dream enactment. THE CHALLENGE RBD affects more than one million Americans and is almost always an early sign of Parkinson's or dementia, often preceding other symptoms by 10-15 years. That means it presents an unprecedented opportunity for developing therapies against Parkinson's disease or dementia and ultimately identifying those who would benefit from early prevention therapy. However, RBD has been very difficult to diagnose. "A simple screening question on whether or not people act out their dreams is poorly sensitive because many people with RBD rarely have full-blown dream enactment episodes but only have small twitches that they or their partners are not aware of," explained Mount Sinai clinician Dr. Emmanuel During. During is associate professor of neurology at the Icahn School of Medicine, where he sees patients at The Mount Sinai Integrative Sleep Center and specializes in movement and sleep disorders, as well as pulmonary medicine and critical care. Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 600 research and clinical labs, a school of nursing, and a leading school of medicine and graduate education. "A simple screening question also is poorly specific because more common conditions – like sleep apnea or a form of restless legs movements during sleep – can cause symptoms of dream-enactment mimicking RBD," During continued. "RBD questionnaires lack accuracy." The gold standard test for diagnosing RBD is an in-lab sleep test in a sleep center, also known as a polysomnogram, which measures muscle activity (increased in RBD) during REM sleep using muscle sensors, or electromyography. But RBD has been very difficult to diagnose using this in-lab sleep test because it's very difficult to interpret and subject to artifacts, to the point that even sleep experts can disagree on the diagnosis. "Notably, although a video camera records any movements during sleep, the current standard for interpreting the test does not take any of that into account, and no automated tool currently exists for interpreting video data," During noted. "In fact, in most sleep centers, the video data is discarded after the sleep test and only the rest of the data collected – EEG, breathing signals, EKG, etc. – will be stored." Furthermore, he said, unless a person undergoing a sleep test is specifically suspected to have RBD by their sleep specialist – based on a history of dream enactment – the diagnosis is easily missed because in 99% of cases, the test is conducted to evaluate for sleep apnea, which does not require assessing muscle activity," he added. This leads to missing "incidental cases" of RBD, which occur in at least 1% of the adult population, according to studies. To address this need, the Mount Sinai research team developed a method for automating the diagnosis of RBD by analyzing video recordings of sleep during in-lab sleep tests. PROPOSAL The team developed an algorithm to automatically interpret the frequency and pattern of body movements detected during REM (rapid eye movement) sleep and determine whether, based on these movements, a person has RBD or not. This had been done only by one group in Austria, but their study used a particular research-grade 3-D camera, which required being added to the standard sleep test hardware. "No study before ours had tested video data routinely collected with the 2-D-infrared camera used in all clinical sleep labs around the world," During said. MEETING THE CHALLENGE "We assembled a large dataset – larger than done in the prior study – comprising 81 sleep study recordings of patients with RBD ('cases') and 91 without RBD ('controls'), including 63 with a range of other sleep disorders and 28 healthy sleepers," During explained. An optical flow computer vision algorithm automatically detected movements during REM sleep, from which features of rate (frequency), ratio (proportion of time in REM sleep showing movements), magnitude and velocity of movements, and ratio of immobility (a measure of the distribution pattern of movements in REM sleep) were extracted, he continued. From those five features, a machine-learning classifier was trained to differentiate RBD from other sleep conditions and normal sleep. "We also were interested in testing the accuracy of the resulting classifier to detect RBD in patients who actually have RBD, but who, on the review of their sleep test, were not reported to move, based on manual review of video footages by a sleep expert," During recalled. "A total of 11 such patients with RBD but no visible-with-the-human-eye movements were identified, and 71 patients with RBD with visible movements." RESULTS The Mount Sinai team found, as they expected, that people with RBD exhibited an increased number of movements in REM sleep, particularly brief movements shorter than 2 seconds, including jerks or twitching known as myoclonus. Accuracies for detecting RBD ranged from 84.9% (with only two features) to 87.2% (with five features). Combining all five features but only analyzing short (less than a 2-second duration) movements achieved the highest accuracy at 91.9%. Of the 11 patients with RBD without noticeable movements during the sleep test, seven were correctly identified, or detected as having RBD, based on the Mount Sinai algorithm. ADVICE FOR OTHERS "This is the first study showing that a simple algorithm analyzing video recordings acquired during sleep tests, conducted under routine clinical care, can diagnose RBD and with a very high accuracy of 91.9%," During noted. "This work improves prior frameworks by using a 2-D camera that is routinely used in sleep laboratories, and improving performance by adding only three features. "This approach could be implemented in clinical sleep laboratories to facilitate and improve the diagnosis of RBD," he concluded. "Coupled with automated detection of REM sleep, it should also be tested in the home environment, using conventional infrared cameras to detect and monitor RBD." Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication. WATCH NOW: Seattle Children's Chief AI Officer talks better outcomes through the technology

Bright Minds Biosciences announced the initiation of Phase 2 clinical trial of BMB-101 in a group of drug-resistant epilepsies and will discuss the details of the BREAKTHROUGH clinical trial on September 25th. The event will feature Epilepsy KOLs to discuss the unmet needs for epilepsy treatment. BMB-101 is the first 5-HT2C agonist in clinical studies designed to exclusively target therapeutic pathways (via G-protein) without receptor desensitization. NEW YORK, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ / CSE: DRUG) announces the Key Opinion Leader (KOL) event with leading experts in epilepsy research and treatment. The event will include Dr. Dennis Dlugos, Dr. Joe Sullivan, and Dr. Jo Sourbron, who will provide critical insights into the evolving landscape of drug-resistant seizures and the unmet needs in epilepsy care. These thought leaders will explore the scientific innovations driving the Phase 2 BREAKTHROUGH clinical trial design announced last week and highlight the potential for novel treatments. Featured KOL speakers Dr. Dennis J. Dlugos , MD, MSCE, is a professor of neurology and pediatrics at Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania School of Medicine. He is the Director of the Section of Clinical Neurophysiology and the Epilepsy/Clinical Neurophysiology Fellowship. He holds the Tristram C. Colket, Jr. Endowed Chair in Pediatric Neurology. Dr. Dlugos is a member of the American Academy of Pediatrics, the American Academy of Neurology, the American Epilepsy Society, the American Clinical Neurophysiology Society, and the Child Neurology Society. Dr. Dlugos is a frequent lecturer locally and at national medical meetings on topics related to pediatric neurology, epilepsy, and electroencephalograms. He has published papers in journals such as Neurology, Epilepsia, Archives of Neurology, Pediatric Neurology, and Journal of Child Neurology . Dr. Joseph Sullivan , a pediatric neurologist, serves as director of the UCSF Pediatric Epilepsy Center, where he specializes in evaluating and caring for children with epilepsy, particularly refractory epilepsy (in which medications fail to control seizures). He has special interests in Dravet syndrome and PCDH19-related epilepsy (two genetic forms of the condition) as well as evaluating children for epilepsy surgery. Dr. Sullivan is a member of the American Epilepsy Society and serves on boards for several organizations. His roles include chair of the PCDH19 Alliance’s scientific advisory board, member of the Epilepsy Foundation of Northern California’s board of directors, and member of the Dravet Syndrome Foundation’s medical advisory board and board of directors. Dr. Jo Sourbron , MD, PhD, MPharm, is a physician scientist with a clinical practice at the University Hospitals of Ghent (UZ Ghent, Belgium) and a postdoctoral researcher at the University of Leuven (UZ/KU Leuven, Belgium). Dr. Sourbron has a special interest in genetic forms of epilepsy and clinical trials for drug-resistant forms of epilepsy. He has been a preclinical researcher for over a decade, focused on finding novel serotonergic (5-HT) compounds for drug-resistant epilepsies. Dr. Sourbron has explored the efficacy and safety of a variety of anti epileptic drugs including, 5-HT2 agonists like fenfluramine and lorcaserin in various animal models. For the past five years, he has been particularly involved in research involving epilepsy with eyelid myoclonia (EEM) with prominent photic induction (Sunflower syndrome). Concomitantly, he was involved in the pilot clinical trial of fenfluramine in Sunflower syndrome patients. Finally, he participated in several other clinical trials for drug-resistant epilepsies, such as cannabidiol in the treatment of drug-resistant epileptic disorders. IMPORTANT INFORMATION: Registration Details: Advance registration is required to participate in the webcast. If you cannot join live, a replay will be available. Register at Livestorm . Q&A Instructions: To ask a question during the live Q&A session, please submit your request through the portal below the webcast player when you register or send an email to info@brightmindsbio.com . About BMB-101 BMB-101 is a novel scaffold 5-HT2C Gq-protein biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively via the Gq-protein signaling pathway and avoids beta-arrestin activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. This provides a novel mechanism, anti-epileptic drug designed to provide sustained seizure relief in hard-to-treat patient populations. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of Dravet Syndrome and numerous models of generalized seizures. In Phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and food-effects study. BMB-101 was demonstrated to be safe and well tolerated at all doses. No Serious Adverse Events (SAEs) were observed, and Adverse Events (AEs) were mild in nature and in line with on-target effects for serotonergic drugs. An extensive target-engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed in this study which could indicate the potential for improved cognition. About Bright Minds Biosciences Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS disorders. Bright Minds is focused on delivering breakthrough therapies that can transform patients’ lives. Bright Minds Biosciences has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry. Forward-Looking Statements This news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include design, progress, and completion of the BREAKTHROUGH Study, future clinical development of BMB-101, and future intended use or therapeutic benefit of BMB-101 to treat refractory epilepsy disorders. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ pro Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release. Contact Information Alex Vasilkevich Chief Operating Officer Bright Minds Biosciences Inc. Phone: (414)7316422 Email: alex@brightmindsbio.com Website:

Now compatible with all major RFID kit and tray systems LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced +RFID smart labels for Diprivan® (Propofol) Injectable Emulsion, USP, 200 mg per 20 mL in single-dose vials, sold in the United States. The +RFID labels are now fully compatible with all major RFID kit and tray systems in the U.S. This press release features multimedia. View the full release here: Fresenius Kabi Diprivan® (Propofol) Injectable Emulsion, USP, 200 mg per 20 mL in single-dose vials, now compatible with all major RFID kit and tray systems. (Photo: Business Wire) The launch expands Fresenius Kabi’s industry-leading +RFID portfolio of fully interoperable labeled medications. The use of radio-frequency identification (RFID) label technology eliminates the need to tag medicines manually which saves time and supports a safe, more efficient medication inventory process. Fresenius Kabi is the first pharmaceutical manufacturer to adopt GS1's EPC Tag Data Standard (TDS) to enhance interoperability. GS1 Standards for identifying, capturing and sharing supply chain data help ensure product and inventory information is accessible, accurate and easy to understand. Diprivan, the most prescribed propofol anesthetic in the U.S.1, was the first Fresenius Kabi product introduced with RFID labels in 2020 for use with some RFID kit and tray systems. The drug is now certified for use with all RFID systems and is available immediately to order through wholesalers and direct from Fresenius Kabi. To meet the highest standards of performance and quality, in addition to the company’s own testing, Diprivan +RFID has been tested by the Axia Institute of Michigan State University and certified by the ARC RFID lab of Auburn University. Fresenius Kabi is expanding its portfolio of fully compatible +RFID products based on demand from hospitals. In a recent study by the ASHP Foundation, nearly nine in 10 hospitals that participated reported they are already using RFID technology or are evaluating it. “We are dedicated to supporting our customers in the adoption of RFID technology that enhances patient care, improves efficiency and streamlines workflows for pharmacists,” said John Ducker, president and CEO of Fresenius Kabi USA. The company has also released newly labeled Vasopressin Injection, USP 20 units per 1 mL in single-dose vials with +RFID smart labels, adding to the company’s growing portfolio of products compatible with all major RFID kit and tray systems. About Diprivan® (Propofol), Injectable Emulsion, USP Indications and Usage – DIPRIVAN® (Propofol), Injectable Emulsion, USP is an intravenous general anesthetic and sedation drug for use in adults for initiation and maintenance of Monitored Anesthesia Care (MAC) sedation, combined sedation and regional anesthesia, and Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients. DIPRIVAN is also indicated for induction of general anesthesia for patients greater than or equal to 3 years of age and for maintenance of general anesthesia for patients greater than or equal to 2 months of age. Important Safety Information DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components, and also in patients with allergies to eggs, egg products, soybeans or soy products. DIPRIVAN is not indicated for use in pediatric patients for ICU sedation or for MAC sedation for surgical, nonsurgical or diagnostic procedures as safety and effectiveness have not been established. DIPRIVAN is not recommended for induction of anesthesia in patients below the age of 3 years or for maintenance of anesthesia in patients below the age of 2 months because its safety and effectiveness have not been established in those populations. Use of DIPRIVAN has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension occur rarely following DIPRIVAN administration. Strict aseptic technique must always be maintained during handling. DIPRIVAN is a single access parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Failure to use aseptic technique when handling DIPRIVAN was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. A DIPRIVAN vial is never to be accessed more than once or used on more than one person. DIPRIVAN has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with DIPRIVAN. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. Diprivan should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. Administer DIPRIVAN with caution in patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis. Very rarely the use of DIPRIVAN may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. When DIPRIVAN is administered to an epileptic patient, there is a risk of seizure during the recovery phase. Attention should be paid to minimize pain on administration of Diprivan. Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (less than 1%). Perioperative myoclonia, rarely including convulsions and opisthotonos, has occurred in association with DIPRIVAN administration. Rarely, cases of unexplained postoperative pancreatitis (requiring hospital admission) have been reported after anesthesia in which DIPRIVAN was one of the induction agents used. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Patients should be continuously monitored for early signs of significant hypotension and/or cardiovascular depression, which may be profound. Abrupt discontinuation of DIPRIVAN prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. In pediatric patients, abrupt discontinuation of DIPRIVAN following prolonged infusion may result in flushing of the hands and feet, agitation, tremulousness and hyperirritability. Increased incidences of bradycardia, agitation, and jitteriness have also been observed. For both adult and pediatric ICU sedation, DIPRIVAN infusion has been associated with Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes and/or cardiac failure. Since DIPRIVAN is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when DIPRIVAN is administered for extended periods of time. Patients at risk of hyperlipidemia should be monitored for increases in serum triglycerides or serum turbidity. EDTA is a strong chelator of trace metals – including zinc. DIPRIVAN should not be infused for longer than 5 days without providing a drug holiday to safely replace estimated or measured urine zinc losses. At high doses (2 grams to 3 grams per day), EDTA has been reported, on rare occasions, to be toxic to the renal tubules. Monitor patients at risk for renal impairment. There have been rare reports of pulmonary edema in temporal relationship to the administration of DIPRIVAN, although a causal relationship is unknown. Neurosurgical Anesthesia: When DIPRIVAN is used in patients with increased intracranial pressure or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decrease in cerebral perfusion pressure. Cardiac Anesthesia: Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shifts, and patients who are hemodynamically unstable. Pediatric Neurotoxicity: Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is unclear. Adverse reactions reported with an incidence greater than 1% were: bradycardia, arrhythmia, tachycardia, hypotension, decreased cardiac output, hypertension, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . DIPRIVAN is not recommended for obstetrics, including Cesarean section deliveries. DIPRIVAN crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN may be associated with neonatal depression. DIPRIVAN is not recommended for use in nursing mothers because Propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known. This Important Safety Information does not include all the information needed to use DIPRIVAN® (Propofol), Injectable Emulsion, USP safely and effectively. Please see full prescribing information for DIPRIVAN® (Propofol), Injectable Emulsion, USP at . References 1. Data on file. About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn.