MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- NeuroPace, Inc. today announced that on February 22, 2013 the U.S. Food and Drug Administration (FDA) Neurological Devices Panel voted unanimously (11 to 0 with two abstentions) that the clinical benefits of the NeuroPace RNS System outweigh the risks of its use. NeuroPace is seeking approval for the RNS System for treating adults with partial onset seizures that have not been controlled with two or more antiepileptic medications. The final decision regarding approval of the device is made by the FDA. We have worked for over 15 years to develop and clinically evaluate the RNS System. We are very excited that patients and physicians who need new treatment options so desperately are now likely to have the RNS System commercially available in the near future, said Frank Fischer, NeuroPace CEO. The RNS System has been evaluated in three clinical trials, including the prospective, randomized, double blinded, sham-stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9% reduction in seizure frequency in the treatment group compared to a 17.3% reduction in the sham-stimulation control group during a three month blinded evaluation period. This difference was statistically significant (p=0.012). Long-term results demonstrated … Continue reading →

Home News Medical Jennifer Lambert and Ryan Bondys dog Simon, a 3-year-old Welsh corgi/fox terrier mix, has been diagnosed with epilepsy. THE BLADE/JEREMY WADSWORTH Enlarge | Buy This Photo Loading Published: 2/25/2013 BY TANYA IRWIN BLADE STAFF WRITER Being adopted by Ryan Bondy and his fiancee, Jennifer Lambert, is the best thing that ever could have happened to Simon, a Welsh corgi and fox terrier mix. About six months ago, a week after they adopted him from a local rescue, the frisky dog tore a knee ligament. While he was recovering from the surgery, he had his first seizure. As it turns out, the 3-year-old dog has epilepsy. We didnt notice any symptoms. He just had a seizure one evening, said Mr. Bondy of Lambertville. We thought it could have been due to the stress of the surgery, but he continued to have seizures every two weeks or so. Mr. Bondy also wondered if the medications given Simon after his surgery might have triggered the seizure. Certainly, there are meds in excessive doses or toxic substances around the home that can cause a seizure, but those would be a one-time, immediate cause and effect, said Simons veterinarian, Dr. Earl Cornprobst … Continue reading →

China's autism oasis By Nick Compton In a classroom for four-year-olds at Elim Autism school in Qingdao city, eastern Shandong province, the teacher draws her students' attention. Standing in the center of a horseshoe of tables, she addresses the eight students sitting at individual desks, their mothers sitting directly behind. "Kan laoshi," (look at me) she begins. Some of the students shift their attention to her, but most remain fixated on the table in front of them, or stare off into empty air. She has them clap their hands and stand up; then she directs them to sit down and settle themselves. She begins her instruction. The task is simple. She has wooden blocks with thread interwoven through. She shows the students how to hold the blocks with one hand and maneuver the thread with the other. Most of the children have to be coerced by their mothers to initiate the activity. Some cry and shout; one repeatedly bangs the desk, refusing to take up the task. Despite their reluctance, these children are luckier than they know. Elim is China's premiere rehabilitation center for autistic children aged three to six. Founded in 2000 by Fang Jing, mother to a now … Continue reading →

Feb. 25, 2013 In a recently published study in the journal Biological Trace Element Research, Arizona State University researchers report that children with autism had higher levels of several toxic metals in their blood and urine compared to typical children. The study involved 55 children with autism ages 5-16 years compared to 44 controls of similar age and gender. The autism group had significantly higher levels of lead in their red blood cells (+41 percent) and significantly higher urinary levels of lead (+74 percent), thallium (+77 percent), tin (+115 percent), and tungsten (+44 percent). Lead, thallium, tin, and tungsten are toxic metals that can impair brain development and function, and also interfere with the normal functioning of other body organs and systems. A statistical analysis was conducted to determine if the levels of toxic metals were associated with autism severity, using three different scales of autism severity. It was found that 38-47 percent of the variation of autism severity was associated with the level of several toxic metals, with cadmium and mercury being the most strongly associated. In the paper about the study, the authors state "We hypothesize that reducing early exposure to toxic metals may help ameliorate symptoms of … Continue reading →

Statistics from Autism Speaks show one out of every 88 children is diagnosed with autism. With that in mind, Lincoln Senator Colby Coash is making a run at helping families cope with the diagnosis. The bill would require insurance companies to pay $70,000 per year for the first 3 years of treatment and $20,000 for every year after that up to age 21. "We designed this bill so that it really covers the treatment that is necessary," says Sen. Coasch. Coash attempted the legislation in 2012, but it didn't pan out. Insurance companies were on the fence and their lobbyists for insurance companies raised concerns. Those who oppose the bill say it's too expensive and that insurance companies can now voluntarily cover these costs. If passed Nebraska would be the 33rd state to require such coverage. The first hearing on LB505 is scheduled for Tuesday, Feb. 26, before the Senate Banking, Commerce and Insurance Committee. More here: Autism Bill Would Help Families Afford Treatment … Continue reading →

The Journal of Medical Toxicology, the official journal of the American College of Medical Toxicology, publishes a study evaluating the effectiveness of an unproven topical treatment for autism in its March issue. Phoenix, AZ (PRWEB) February 26, 2013 In the study, the researchers were unable to detect any DMPS in the blood following its application, demonstrating that the product is not absorbed through the skin. Without absorption, TD-DMPS cannot exert its purported effects of removing heavy metals from the body. The study confirmed this by demonstrating that the urinary elimination of mercury, a metal known to be removed from the body when DMPS is given by mouth or the intravenous route, did not increase after application of the product. According to an accompanying editorial by Charles McKay MD, Medical Director of the Department of Occupational Health Services and Section Chief of the Division of Medical Toxicology at Hartford Hospital in Connecticut, Despite the absence of data, and in the face of such concerns about absorption and dose, many advocates of a heavy metal toxic etiology for autism (in particular mercury) have incorporated TD-DMPS into their non-traditional practice. We should recognize, however, the frustration and despair that leads members of the … Continue reading →

Cathy and Cesar Martinez noticed an abrupt change in their 20-month-old son, Jacob, in 2005. Within months, he lost all language skills. He would no longer make eye contact with others or respond when his name was called. He stopped playing. He spent most of his time sitting in the corner, banging his head against the wall. When Jacob was diagnosed with moderate to severe autism, his parents immediately began private speech and occupational therapy for Jacob. "We saw minimal progress, if any, at all, that first year," Cathy Martinez said. They sought out a local pediatric behavioral psychologist specializing in autism spectrum disorders, who recommended a treatment called Applied Behavioral Analysis, which is based on theories that behaviors can be taught through a system of rewards and consequences. It would cost $62,000 a year. "She warned us that insurance will not pay for autism treatment in the state of Nebraska," Martinez said. "We left feeling devastated, that a treatment existed that could help our child, but our insurance refuses to cover it." On Tuesday, the Legislature's Banking, Commerce and Insurance Committee discussed a bill (LB505) that would require insurance companies to pay for autism diagnoses and treatment. Link: Bill … Continue reading →