The FDA announced today a proposal to ban electrical stimulation devices (ESDs) which are known to be used on autistic people who are “self-injurious or aggressive.” The FDA stated the devices “present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes in labeling.” Evidence of adverse effects caused by ESDs included “significant psychological and physical risks …including depression, anxiety, worsening of self-injury behaviors and symptoms of post-traumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.” Note this is a proposed ban. Once this proposal is published in the Federal Register, Monday, April 25, 2016, there is a 30 day comment period for the general public.
The FDA has known about this shock device for years. The FDA had previously warned the Judge Rotenberg Center in 2011 and 2012 that their ESD was out of compliance with FDA regulations as the device had been modified to allow increases in voltage. Originally, the ESD had been approved in 1994 at a set voltage. This Judge Rotenberg Center is the only known location in the United States that uses the device; the Center was previously known as the Behavioral Research Institute and has moved over the years from California to Rhode Island to its present location in Massachusetts.
Additionally, even the UN has advocated the ESD be banned. Back in 2013, the UN’s special rapporteur on torture, Juan Mendez, called out the Judge Rotenberg Center for using this electrical stimulation device on those with autism and said the device amounted to torture. Mr. Mendez advocated at that time that action be taken at the federal level.
Sources: FDA.gov http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm497194.htm
Office of the Federal Register: https://www.federalregister.gov/articles/2016/04/25/2016-09433/banned-devices-electrical-stimulation-devices-used-to-treat-self-injurious-or-aggressive-behavior
Forbes.com http://www.forbes.com/sites/emilywillingham/2016/04/22/fda-seeks-to-ban-electric-shock-devices/#4856b7237ead AND
Pitt-Hopkins Syndrome, which is present at birth or develops in early childhood, is caused by mutations in the TCF4 gene located on chromosome 18q21.2. There are reportedly only 500 cases of the syndrome in the world though it is thought the syndrome may be underdiagnosed. One of the major reasons for this likely underdiagnosis is the syndrome has many characteristics that are also associated with autism spectrum disorders; although there are other distinctive features of the syndrome as well.
Like autism spectrum disorders, many of those with Pitt-Hopkins Syndrome have delayed development of mental and motor skills. People with the syndrome typically do not develop speech or learn only a few words. Delays often occur in learning to walk. Additionally, their demeanor is “typically … happy, excitable…with frequent smiling, laughter and hand-flapping movements.” Those with the syndrome commonly experience “anxiety and behavioral problems;” and they may also experience recurrent seizures.
Some unique features of Pitt-Hopkins Syndrome are breathing problems and certain facial and ear characteristics. The breathing problems can fluctuate between hyperventilation and slowed breathing or even apnea and may be triggered by “fatigue, anxiety or excitement.” The distinctive facial features are “thin eyebrows, sunken eyes, a prominent nose with a high nasal bridge, a pronounced double curve of the upper lip called Cupid’s bow, wide mouth with full lips and widely spaced teeth.” Additionally, the ears may be “thick and cup-shaped.”
A recent gene research breakthrough that may lead to a treatment for Pitt-Hopkins Syndrome was discovered by scientists at the Johns Hopkins University-affiliated independent laboratory, the Lieber Institute for Brain Development. The researchers studied the brains of rats affected by Pitt-Hopkins Syndrome and found “alternative channels in the brain interrupting normal cell activity.” The gene research showed these interruptions caused inappropriate responses to stimuli in the environment. Further, the researchers discovered a drug being “investigated for use on chronic pain” that blocked these alternative channels resulting in cells behaving normally. However, at this point, researchers are not sure what restoring normal cell activity would do to those with the syndrome but are hopeful that some of the deficits could be eliminated.
Sources: CapitalGazette.com of March 11, 2016.
Ghr.nlm.nih.gov; “Pitt-Hopkins Syndrome;” Last reviewed February 2015.
You may have read of recent news reports of autistic children who wandered off from home and were later found dead, often from drowning. To help with the wandering problem, Project Lifesaver was developed to help those with autism, Down Syndrome, Alzheimer’s disease and other cognitive disorders who have wandered off to be brought home in a timely manner.
The company behind Project Lifesaver is Project Lifesaver International (PLI) which is a 501c3 non-profit organization. There are three components to their program: Teaching search and rescue techniques; applying “appropriate tracking technology;” and providing a basic understanding of autism, dementia and other cognitive disorders while certifying first responders in techniques to “assess and effectively manage the safe and comfortable return” of the individual with a brain disorder who wanders.
PLI has developed three possible options on how their program can be used. Option 1 is the original Project Lifesaver International program where an agency makes the purchase and maintenance of all tracking equipment and transmitters. The agency making the purchase will maintain all of the information regarding the “at risk” individual and their family or caregiver (hereafter referred to as “client”) in the PLI database and are solely responsible for all of the financial transactions to PLI.
Option 2 is similar to option 1 in that an agency purchases the tracking equipment and gets training from Project Lifesaver International. However, the client will purchase the transmitters and pay the monthly maintenance fee directly to PLI. The agency maintains all of the client information instead of PLI and PLI only receives the information necessary in order to supply the necessary equipment to the client.
With Option 3, a client enrolls with Project Lifesaver directly, purchases the transmitters and does the monthly maintenance. The agency involvement is limited to PLI sharing with the agency the information needed on the “at risk” individual in the event of a search.
A new study published this month by the American Association of the Advancement of Science indicates that immune cells “may have a direct role in causing behaviors linked to autism.” The study abstract noted that previous research has already shown “viral infection during pregnancy has been correlated with increased frequency of autism spectrum disorder in offspring.”
For this study, researchers at New York University Langone studied a subset of T-helper lymphocyte cells called TH17 and the production of cytokine interleukin-17a (IL-17a). The study in mice mimicked a viral invasion and showed using genetic mutants and blocking antibodies that TH17 and IL-17a caused maternal immune activation (MIA) behavior abnormalities in mice offspring. Additionally, the study demonstrated that “blocking the action of TH17 and IL-17a completely restored normal structure and functioning” in the mice offspring brains. The study’s authors suggest that the “therapeutic targeting of TH17 cells in susceptible pregnant mothers may reduce the likelihood of bearing children with inflammation-induced” autism spectrum disorder behaviors.
Scientists in France have identified a genetic marker for autism that they found in a “less deep fold of Broca’s area” — an area of the brain that specializes in language and communication. The scientists at the Institut de Neurosciences de la Timone, located in Marseille, focused on this “new geometric marker called the sulcal pit.” The sulcal pit is the “deepest point of the sulcus in the cerebral cortex from which points all the folds on the brain’s surface develop.”
Using MRI scans, the scientists analyzed the sulcal pits of 102 young boys aged 2-10 according to three groups: Autism spectrum disorder, pervasive developmental disorder not otherwise specified and “normal developing” children. Comparing the three groups, the depth of the sulcal pit in the brain was less in the autism spectrum disorder group than in the other two groups. The scientists also noted in the autistic children that the deeper the sulcal pits were, the more “impaired the language production” was in the children.
Additionally, the study disproved a previously held belief that brain “cortical folding was complete at birth.” The French scientists noted that some of the brains’ “superficial folding continued to deepen with age in both the autistic and other children.”
Source: http://www.sciencedaily.com/releases/2016/01/160113101121.htm including journal reference Brun Lucile, Auzias Guillaume, Viellard Marine, Villeneuve Nathalie, Girard Nadine, Poinso François, Da Fonseca David, Christine Deruelle. Localized misfolding within Broca’s area as a distinctive feature of autistic disorder. Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, 2015; DOI: 10.1016/j.bpsc.2015.11.003 published 12 January 2016.
Milo, is a two foot-tall humanoid robot that uses facial expressions and children’s voices to demonstrate appropriate social behavior in order to help kids with autism learn social skills. The robot was developed by Robokind and the children’s voices were developed by Acapela Group to help autistic kids engage with the robot in order to teach them the meaning of emotions and facial expressions.
Milo uses the Robots4Autism’s research-based curriculum to teach elementary and middle school-aged kids about acting appropriately in social situations and demonstrating empathy while encouraging more self-motivation in the kids. “Recent research has shown that children working with a therapist and Milo are engaged 70-80% of the time compared to just 3-10% of the time without the robot.”
Robots4Autism’s curriculum for kids with autism is available in Android and iOS. Some of the benefits of the curriculum are noted to be “observable increases in eye contact, body language and friendliness, intrinsically motivates children to learn and documents and records sessions for later inclusion and review in IEPs.” You can find out more about Milo and the Robots4Autism curriculum at the robokindrobots’ website.
Researchers recently published a study in the Journal of Autism and Developmental Disorders called “Persistent Angiogenesis in the Autism Brain: An Immunocytochemical Study of Postmortem Cortex, Brainstem and Cerebellum.” The study found that the brains of those with autism have “unstable blood vessels disrupting proper delivery of blood to the brain.” “Typical” brain blood vessels are stable.
The researchers conducted the study by looking microscopically at post-mortem age-matched normal brains and autistic brains. The researchers did not know which brains had had an autism diagnosis and which brains did not thus eliminating bias in their observations. The study found formation of new blood vessels (angiogenesis) in the brains from individuals who had had an autism diagnosis; no such angiogenesis was noted in the normal brains. The areas of the brain affected were the “superior temporal cortex (primary auditory cortex), fusiform cortex (face recognition center), pons/midbrain and cerebellum.” Specifically, the researchers found increased levels of the proteins nestin and CD34 which are markers of angiogenesis. Importantly, the study findings found that the angiogenesis was not the kind that caused the sprouting of new vessels but instead of splitting, thus causing continuous fluctuations in blood circulation.