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By Michelle Marchante, Miami Herald (TNS) MIAMI — As her students finished their online exam, Arlet Lara got up to make a cafe con leche . Her 16-year-old son found her on the kitchen floor. First, he called Dad in a panic. Then 911. “I had a stroke and my life made a 180-degree turn,” Lara told the Miami Herald, recalling the medical scare she experienced in May 2020 in the early months of the COVID pandemic. “The stroke affected my left side of the body,” the North Miami woman and former high school math teacher said. Lara, an avid runner and gym goer, couldn’t even walk. “It was hard,” the 50-year-old mom said. After years of rehabilitation therapy and a foot surgery, Lara can walk again. But she still struggles with moving. This summer, she became the first patient in South Florida to get an implant of a new and only FDA-approved nerve stimulation device designed to help ischemic stroke survivors regain movement in their arms and hands. This first procedure was at Jackson Memorial Hospital in Miami. Lara’s rehab was at at the Christine E. Lynn Rehabilitation Center for The Miami Project to Cure Paralysis, part of a partnership between Jackson Health System and UHealth. Every year, thousands in the United States have a stroke , with one occurring every 40 seconds, according to the U.S. Centers for Disease Control and Prevention. The majority of strokes are ischemic, often caused by blood clots that obstruct blood flow to the brain. For survivors, most of whom are left with some level of disability, the Vivistim Paired VNS System, the device implanted in Lara’s chest, could be a game changer in recovery, said Dr. Robert Starke, a UHealth neurosurgeon and interventional neuroradiologist. He also serves as co-director of endovascular neurosurgery at Jackson Memorial Hospital, part of Miami-Dade’s public hospital system. Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant, right, runs into her rehabilitation neurology physician Dr. Gemayaret Alvarez, before her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The implant is designed to help stroke survivors regain function in their arms. (Alie Skowronski/Miami Herald/TNS) Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant designed to help stroke survivors regain function in their arms, goes through exercises while her therapist activates the device during her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The activation works as positive reinforcement to her muscles when she completes the exercise correctly. (Alie Skowronski/Miami Herald/TNS) Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant, does an exercise while Neil Batungbakal, rehabilitation therapist, activates the implant with the black trigger during her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The implant is designed to help stroke survivors regain function in their arms. The activation works as positive reinforcement to her muscles when she completes the exercise correctly. (Alie Skowronski/Miami Herald/TNS) Arlet Lara, the first patient in South Florida to get an FDA- approved nerve stimulation implant, does an exercise while Neil Batungbakal, rehabilitation therapist, activates the implant with the black trigger during her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. Arlet Lara, the first patient in South Florida to get an FDA-approved nerve stimulation implant, right, runs into her rehabilitation neurology physician Dr. Gemayaret Alvarez, before her physical therapy appointment on Monday, Sept. 9, 2024, at Lynn Rehabilitation Center at Jackson Memorial Hospital. The implant is designed to help stroke survivors regain function in their arms. (Alie Skowronski/Miami Herald/TNS) The Vivistim Paired VNS System is a small pacemaker-like device implanted in the upper chest and neck area. Patients can go home the same day. The U.S. Food and Drug Administration approved the stroke rehabilitation system in 2021 to be used alongside post-ischemic stroke rehabilitation therapy to treat moderate to severe mobility issues in hands and arms. Lara’s occupational therapist can activate the device during rehabilitation sessions to electrically stimulate the vagus nerve, which runs from the brain down to the abdomen and regulates various parts of the body’s nervous system. The electrical stimulation rewires the brain to improve a stroke survivor’s ability to move their arms and hands. Lara also has a magnet she can use to activate the device when she wants to practice at home. Her therapy consists of repetitive tasks, including coloring, pinching cubes and grabbing and releasing cylindrical shapes. After several weeks of rehabilitation therapy with the device, Lara has seen improvement. “Little by little, I’m noticing that my hand is getting stronger. I am already able to brush my teeth with the left hand,” she told the Miami Herald in September. Since then, Lara has finished the initial six-week Vivitism therapy program, and is continuing to use the device in her rehabilitation therapy. She continues to improve and can now eat better with her left hand and can brush her hair with less difficulty, according to her occupational therapist, Neil Batungbakal. Lara learned about the device through an online group for stroke survivors and contacted the company to inquire. She then connected them with her Jackson medical team. Now a year later, the device is available to Jackson patients. So far, four patients have received the implant at Jackson. Related Articles Starke sees the device as an opportunity to help bring survivors one step closer to regaining full mobility. Strokes are a leading cause of disability worldwide. While most stroke survivors can usually recover some function through treatment and rehabilitation, they tend to hit a “major plateau” after the first six months of recovery, he said. Vivistim, when paired with rehabilitation therapy, could change that. Jackson Health said results of a clinical trial published in the peer-reviewed medical journal The Lancet in 2021 showed that the device, “when paired with high-repetition, task-specific occupational or physical therapy, helps generate two to three times more hand and arm function for stroke survivors than rehabilitation therapy alone.” The device has even shown to benefit patients 20 years from their original stroke, according to Starke. “So now a lot of these patients that had strokes 10-15 years ago that thought that they would never be able to use their arm in any sort of real functional way are now able to have a real meaningful function, which is pretty tremendous,” Starke said. Vivistim’s vagus-nerve stimulation technology was developed by researchers at the University of Texas at Dallas’ Texas Biomedical Device Center and is being sold commercially by Austin-based MicroTransponder, a company started by university graduates. Similar devices are used to treat epilepsy and depression . For Lara, the device is a new tool to help her recovery journey. “Everything becomes a challenge so we are working with small things every day because I want to get back as many functions as possible,” Lara said. Patients interested in Vivistim should speak with their doctor to check their eligibility. The FDA said patients should make sure to discuss any prior medical history, including concurrent forms of brain stimulation, current diathermy treatment, previous brain surgery, depression, respiratory diseases and disorders such as asthma, and cardiac abnormalities. “Adverse events included but were not limited to dysphonia (difficulty speaking), bruising, falling, general hoarseness, general pain, hoarseness after surgery, low mood, muscle pain, fracture, headache, rash, dizziness, throat irritation, urinary tract infection and fatigue,” the FDA said. MicroTransponder says the device is “covered by Medicare, Medicaid, and private insurance with prior authorization on a case-by-case basis.” To learn more about the device, visit vivistim.com. ©2024 Miami Herald. Visit at miamiherald.com. Distributed by Tribune Content Agency, LLC.

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Police used tear gas and water cannon against demonstrators in Georgia protesting a government decision to delay pursuing European Union accession. Thousands rallied in the capital Tbilisi and cities across Georgia after Prime Minister Irakli Kobakhidze announced the decision amid a post-election crisis. The prime minister's announcement came hours after the European Parliament adopted a non-binding resolution rejecting the results of Georgia's 26 October parliamentary elections, alleging "significant irregularities". Thousands rallied in the capital Tbilisi and cities across Georgia after Prime Minister Irakli Kobakhidze announced the decision amid a post-election crisis that saw the country's president challenge the legitimacy of the newly elected parliament and government. Waving EU and Georgian flags, thousands rallied outside parliament, blocking traffic on the Georgian capital's main road in the latest of a series of protests in the country. Shortly after midnight, riot police deployed tear gas and water cannon against the peaceful demonstrators. The crackdown continued into the early hours, with masked police firing rubber bullets and brutally beating protesters and journalists. Demonstrators erected barricades and set them on fire while local media reported several protesters and journalists were arrested. "I stand with the Georgian media, who are disproportionately targeted and attacked while doing their job and reporting continuously," pro-Western President Salome Zurabishvili said on social media. READ | Thousands of Georgians defy warnings to join protest against 'Russia' bill The prime minister's announcement came hours after the European Parliament adopted a non-binding resolution rejecting the results of Georgia's 26 October parliamentary elections, alleging "significant irregularities". The resolution called for new elections within a year under international supervision and for sanctions to be imposed on top Georgian officials,... news24LOS ANGELES — The locker room after the Rams’ 37-20 loss to the Philadelphia Eagles was as quiet as any this season. Players shouldered blame in quiet, shorts responses to reporters’ questions before filing out and into the night. As they dissected what had just happened, the Rams (5-6) also looked ahead and stated they could not afford for this game to spiral into the next game, which is Sunday’s matchup with the New Orleans Saints (4-7). “Just make sure you turn the page. Obviously, there are things that we want to correct from the game and find ways to be better moving forward, but make sure that we come out with great energy today. It starts today,” Rams quarterback Matthew Stafford said before Wednesday’s practice. “There are going to be things we want to clean up from practice, make sure we do that and move on day-to-day with the right attitude and the right spirit.” As the Rams have gone about making those corrections, a consistent word has come to mind: Consistency. Asked what he’s looking for from the defense Sunday after its worst performance since the early weeks of the season, head coach Sean McVay used that word. He spoke about playing as a unit, sticking to assignments, coverage and pass rush complementing each other. Then he added with a smile, “Same things I’m looking for on the defense would be exactly how I would answer your offensive question as well.” Even 11 games into the season, we still haven’t seen the Rams offense perform with the type of consistency you would expect from a group with this much talent. Against the Eagles, the Rams moved the ball well in the first quarter, reaching the red zone twice without needing a third down. But any momentum was quickly lost with a 10-play second quarter that resulted in a loss of six yards. It was the same story a week before, with the offense blazing in the second and third quarters against the Patriots while going nowhere in the first and fourth quarters. “It’s kind of the word ‘consistency’ right now,” Rams offensive coordinator Mike LaFleur said. “There are times where it feels like we go right down the field and put it in, and there are other times where it just feels a little bit harder than it should. I think that’s the biggest key right now.” The defense is facing a similar obstacle. The Rams are among the best in the NFL at holding teams without a touchdown in the red zone, limiting opponents to a 48.8% success rate. That ranks eighth in the league, but the flip side is that the Rams allow teams 3.7 trips into the red zone per game, which is tied for 28th. Defensive tackle and captain Kobie Turner raised the issue of allowing too many long drives following the Eagles loss, and defensive coordinator Chris Shula agreed with the assessment. “Some of that, especially the other night, they were in third downs a decent amount of time and it was a third and favorable,” Shula said. “Then, finding a way to get stops, finding a way to play, get them off track, get them into 2nd-and-longs where you get those 3rd-longs, and you can earn the right to rush the passer.” Entering Week 13, it’s not encouraging that the Rams are still struggling to find consistency in their execution. But to this point, it hasn’t upended their season. The wild card might be out of reach, but the NFC West title is still up for grabs. But that starts with a road win against a Saints team playing with nothing to lose. “We know that it’s going to be a great challenge, especially at their place. It’ll be rocking atmosphere and environment with the holidays and the momentum they have,” McVay said. “We’ve a lot of guys that are experiencing things for the first time. I have seen the resolve of this group show itself. Now, we’ve to do it.” RAMS (5-6) at NEW ORLEANS SAINTS (4-7) When: 1:05 p.m. Sunday Where: Superdome, New Orleans TV/radio: FOX (Ch. 11)/710 AM; 93.1 FM; 1330 AM (Spanish); Sirius 382, 226

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