In response to criticism that epilepsy care for children has little impact, healthcare professionals and administrators have developed various service models and strategies to address perceived inadequacies.
The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox, Allergan) to ease lower-limb spasticity in children and adolescents aged 2 years to 17 years, excluding spasticity caused by cerebral palsy (CP), Allergan announces.
“Lower limb spasticity can impact many aspects of a child’s life and have a drastic influence on their overall development and quality of life,” David Nicholson, Allergan’s chief research and development officer, says in a news release.
The FDA approved Botox for lower-limb spasticity on the basis of safety and efficacy data from a phase 3 study involving more than 300 children aged 2 years or older with lower-limb spasticity.
Participants in the trial had CP, but the approved indication excludes lower-limb spasticity caused by CP, owing to marketing exclusivity by another company, according to Allergan.
The approved recommended dose per treatment session is 4 to 8 units/kg divided among affected muscles of the lower limb. The total dose for pediatric patients should not exceed 8 units/kg body weight, or 300 units, whichever is lower.
When treating both lower limbs or upper and lower limbs in combination, the total dose for pediatric patients should not exceed 10 units/kg, or 340 units, whichever is lower, in a 3-month interval, the company states.
“Pediatric lower limb spasticity inhibits normal muscular movement and function and can result in delayed or impaired motor development, as well as difficulty with posture and positioning,” Mark Gormley, Jr, MD, of Gillette Children’s Specialty Healthcare–St. Paul, comments, in the release.
“Botox has a well-established safety and efficacy profile, and supports children and adolescents successfully manage both their upper and lower limb spasticity,” said Gormley.
Botox was approved for pediatric upper-limb spasticity in June.
|Parenting is a challenging life role for all people, yet one of the most valued roles within society. Brain Injury frequently occurs at a life stage where people are yet to complete their parenting responsibilities. For people with acquired brain injury (ABI), facing cognitive, physical, communication, behavioural and psychological challenges, parenting can present complex challenges. In addition, persons with ABI often face societal and environmental barriers. These fact sheets have been developed to assist parents with an ABI and their partners to improve their knowledge and skills to meet the ongoing challenges of parenting.|
April 4, 2019
In our series #TechThursdays, we bring you news about Virtual Rehabilitation (VHAB) and Assisto devices. VHAB, which is based on virtual reality and Assisto, which is on artificial intelligence, are targeted at people with neuromuscular disabilities.
Tech giant Tata Consultancy Services (TCS) are looking to enable people with neuromuscular disabilities in a big way with VHAB (Virtual Rehabilitation) and Assisto. The two devices use the latest available technologies to enhance communication skills.
Assisto addresses the communication difficulties that many people with cerebral palsy face by tuning their voices for better clarity. This is achieved with Algorithm, a speech synthesis. So, when the user speaks, the listener will hear a clearer enunciation.
VHAB, on the other hand, us targeted at children with neuromuscular disabilities like cerebral palsy and autism. Many children diagnosed with disabilities are put through rigorous physiotherapy sessions which can be tiring. VHAB makes these sessions game-based with the help of virtual reality. Gesture analysis, finger-mapping and motion sensors will be used for this.
Both Assisto and VHAB have been successfully tested on children at the Adarsh School in Kochi.
Ashwin Kumar, Principal, Adarsh School believes taht the devices will revolutionize the way people with neuromuscular disabilities communicate.
People with cerebral palsy and autism may have issues with their tongue muscles that can affect communication. Assisto and VHAB devices are definitely going to help them. The software that was developed by TCS was tested on two of our children and it worked really well. In their next phase of the project, they are planning to introduce this to more children and reach out to people who need it.- Ashwin Kumar, Principal, Adarsh School
These devices will also make day-to-day tasks also easier for children with neuromuscular disabilities. The team fine-tuned the devices over three years.
“They provide a gameified app platform and a game environment is created for the user”, says Robin Tommy one of the members of the team that worked on developing them. “It is a combination of physical and game therapies and pain-free as well so kids would love it. The devices aim to enable movements for the user and motivate them to do daily activities with ease. It is mainly based on gesture and motion”.
Seema Lal, Co-founder of TogetherWeCan, a well known parents supports group in Kerala, believes that technologies like these will be game changers for people with disabilities.
‘We often talk about how technology can be a curse when it comes to things like game addiction and so on. At the same time, it can be a boon for children with neuromuscular disabilities. The United Nations is already talking about the benefits of assistive technology for people with disabilities, and in enabling them to participate actively in many things. I believe this new initiative from TCS is brilliant. Communication is the key for any person and technology is truly a boon”, says Lal.
This is a CSR project of TCS and the great news is that it plans to look at ways to introduce Assisto and VHAB in other schools as well as NGOs. VHAB was recently launched at the ZEP Rehabilitation Centre in Pune,
Medical University of South Carolina (MUSC) neurologists have developed a new method based on artificial intelligence that may eventually help both patients and doctors weigh the pros and cons of using brain surgery to treat debilitating seizures caused by epilepsy. This study, which focused on mesial temporal lobe epilepsy (TLE), was published in the September 2018 issue of Epilepsia. Beyond the clinical implications of incorporating this analytical method into clinicians’ decision making processes, this work also highlights how artificial intelligence is driving change in the medical field.
Despite the increase in the number of epilepsy medications available, as many as one-third of patients are refractory, or non-responders, to the medication. Uncontrolled epilepsy has many dangers associated with seizures, including injury from falls, breathing problems, and even sudden death. Debilitating seizures from epilepsy also greatly reduce quality of life, as normal activities are impaired.
Epilepsy surgery is often recommended to patients who do not respond to medications. Many patients are hesitant to undergo brain surgery, in part, due to fear of operative risks and the fact that only about two-thirds of patients are seizure-free one year after surgery. To tackle this critical gap in the treatment of this epilepsy population, Dr. Leonardo Bonilha and his team in the Department of Neurology at MUSC looked to predict which patients are likely to have success in being seizure free after the surgery.
Neurology Department Chief Resident Dr. Gleichgerrcht explains that they tried “to incorporate advanced neuroimaging and computational techniques to anticipate surgical outcomes in treating seizures that occur with loss of consciousness in order to eventually enhance quality of life”. In order to do this, the team turned to a computational technique, called deep learning, due to the massive amount of data analysis required for this project.
The whole-brain connectome, the key component of this study, is a map of all physical connections in a person’s brain. The brain map is created by in-depth analysis of diffusion magnetic resonance imaging (dMRI), which patients receive as standard-of-care in the clinic. The brains of epilepsy patients were imaged by dMRI prior to having surgery.
Deep learning is a statistical computational approach, within the realm of artificial intelligence, where patterns in data are automatically learned. The physical connections in the brain are very individualized and thus it is challenging to find patterns across multiple patients. Fortunately, the deep learning method is able to isolate the patterns in a more statistically reliable method in order to provide a highly accurate prediction.
Currently, the decision to perform brain surgery on a refractory epilepsy patient is made based on a set of clinical variables including visual interpretation of radiologic studies. Unfortunately, the current classification model is 50 to 70 percent accurate in predicting patient outcomes post-surgery. The deep learning method that the MUSC neurologists developed was 79 to 88 percent accurate. This gives the doctors a more reliable tool for deciding whether the benefits of surgery outweigh the risks for the patient.
A further benefit of this new technique is that no extra diagnostic tests are required for the patients, since dMRIs are routinely performed with epilepsy patients at most centers.
This first study was retrospective in nature, meaning that the clinicians looked at past data. The researchers propose that an ideal next step would include a multi-site prospective study. In a prospective study, they would analyze the dMRI scans of patients prior to surgery and follow-up with the patients for at least one year after surgery. The MUSC neurologists also believe that integrating the brain’s functional connectome, which is a map of simultaneously occurring neural activity across different brain regions, could enhance the prediction of outcomes.
Dr. Gleichgerrcht says that the novelty in the development of this study lies in the fact that this “is not a question of human versus machine, as is often the fear when we hear about artificial intelligence. In this case, we are using artificial intelligence as an extra tool to eventually make better informed decisions regarding a surgical intervention that holds the hope for a cure of epilepsy in a large number of patients.”
The virtual reality (VR) system Serious Game may help children with cerebral palsy and other neurological impairments rehabilitate their upper limbs, suggests a study conducted by a team of Italian researchers who developed the system.
The study, published recently in IEEE Transactions on Neural Systems and Rehabilitation Engineering, examined Serious Game, which is composed of a virtual reality camera mounted to the head and two wearable haptic devices placed on two fingers.
In their study, the team investigated the usability of this rehabilitation system in three patients with cerebral palsy and five patients with developmental dyspraxia—a disorder characterized by the impairment of the ability to plan and carry out sensory and motor tasks. The mean age of participants in this group was 10.13 years, according to a news story from Cerebral Palsy News Today.
Typically developing children, with a mean age of 13.38 years, and adults, with a mean age of 26.75 years, also were included in the study.
The participants were divided into two groups: one assisted by the Serious Game technology and another undergoing conventional neurocognitive rehabilitation therapy. Both conditions required movements involving similar motor functions, such as reaching, grasping, and rotating both forearms and hands, but with different tasks and goals in various contexts.
The children attended 16 training sessions of two sessions per week for 4 weeks, over two separate periods. Between the two interventions, a washout period of 4 weeks was added in which children followed only cognitive therapy with no physical sessions.
The children’s exercise capacity was measured using validated clinical scales and motion analysis, the news story continues.
Typically developing children were eager to complete the assigned task even though they were instructed to execute the session with attention and without rushing, while the adults, cerebral palsy, and developmental dyspraxia groups seemed to pay greater attention to precisely performing motor tasks.
The accuracy and velocity of movement were only different between typically developing children and neuromotor patients in the reach-to-grasp exercise, in which children were asked to flip a card protruding from a horizontal support. No significant differences were observed in the path-tracking task, in which children were seated in front of a desk and asked to reach a target by moving the hand along a straight path, the story explains.
Children with neurological disorders completed the game without exceeding the maximum time threshold imposed. Also, these children reported positive feedback after participating in the Serious Game.
The results of virtual reality were consistent with the participants’ motor skills. Overall, the cerebral palsy and developmental dyspraxia group had lower performance than typically developing children and adults, while in turn, the typically developing children had lower performance than adults.
“Results show the system was compliant with different levels of motor skills and allowed patients to complete the experimental rehabilitation session, with performance varying according to the expected motor abilities of the different groups,” researchers wrote, in the study.
“The ability both to customize the modalities of interaction with the virtual environment and, in the same time, to arise motivation in young participants have revealed virtual reality as a potentially important rehabilitation tool in these children,” they add, per the news story.
In the future, the team plans to study this approach in a larger population.
[Source: Cerebral Palsy News Today]
The International Ketogenic Diet Study Group has released new clinical guidelines on the ketogenic diet in children with epilepsy. The updated recommendations are the first change since the original guidelines on the subject were published almost 10 years ago.
An advisory panel from the United States Food and Drug Administration (FDA) has recommended the approval of a novel epilepsy drug that is made up of ingredients from marijuana. The agency normally follows the recommendations of the advisory panels regarding approvals and rejections of applications of new drugs. The recommendation statement came yesterday (19th April 2018).
If this drug gets a green light, it is expected to become the first cannabis-derived prescription medicine to be available in the US. The drug is named Epidiolex and is made by GW Pharmaceuticals from Britain. It contains cannabidiol or CBD that is derived from cannabis. However the drug is not seen to cause any intoxication among the users.
The use of only one of the components of cannabis also makes it different from medical marijuana that is approved for pain management and other conditions around the world and in the United States. Synthetic forms of chemicals in the cannabis plant are also used to treat nausea among cancer patients and in AIDS patients to prevent weight loss.
Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego welcomed this new recommendation from the panel saying, “This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids… I think there could well be other cannabinoids that are of therapeutic use, but there is just not enough research on them to say.”
As of now the panel has recommended the use of this new drug for two types of epilepsy only – Lennox-Gastaut syndrome and Dravet syndrome. These are notoriously difficult to treat and most people continue to have seizures despite treatment. Multiple seizures may occur in a day and this makes the children with these conditions vulnerable for developmental and intellectual disabilities. Lennox-Gastaut syndrome can appear in toddlers at around ages 3 to 5 and Dravet syndrome is usually diagnosed earlier. Nearly 30,000 children and adults suffer from Lennox-Gastaut syndrome and similar numbers of people are diagnosed with Dravet syndrome. Due to the small population of diagnosed patients Epidiolex was filed and classified under orphan drug status.
An orphan drug is one that is developed for a relatively rare disease condition. The FDA provides special subsidies and support for development of orphan drugs and often speed tracks their approval process.
The recommendation from the advisory panel is based on the results of three randomized, double-blind, placebo-controlled trials that included patients of both these disease conditions. The agency statement says, “The statistically significant and clinically meaningful results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.” They drug causes liver damage but the report says that this could be managed effectively.
The FDA will conduct a final vote for approval of this drug in June. Oral solution of the drug for a small group of patients with these conditions would be allowed.
According to a new study from the Columbia University however, brain cells are continuously added to our brains even when we reach our 70s. This is a process called neurogenesis. Their work is published in a study that appeared in the latest issue of the journal Cell Stem Cell this week.
Lead author Dr. Maura Boldrini, a research scientist at the department of psychiatry, Columbia University and her colleagues investigated the brains of 28 dead people aged between 14 and 79 years. They were studying the effects of aging on the brain’s neuron production. The team examined the brains that were donated by the families of the deceased at the time of death. The brains were frozen immediately at minus-112 degrees Fahrenheit before they could be examined. This preserved the tissues.
Neurogenesis has been shown to decline with age in lab mice and rats as well as in experimental primates. The team wanted to explore if same rates of decline are seen in human brains as well. So they checked the brains samples for developing neurons. These developmental stages included stem cells, intermediate progenitor cells, immature neuronal cells and finally new mature neurons. They focused on the hippocampus region of the brain that deals with memory and emotional control and behavior.
The results revealed that for all age groups, the hippocampus shows new developing neurons. The researchers concluded that even during old age, the hippocampus continues to make new neurons. The differences that they noted with age include reduction in the development of new blood vessels as people got older. The proteins that help the neurons to make new connections are reduced with age. This was a finding that differentiated ageing brains from younger ones, they explained. Boldrini said the new neurons are there in older brains but they make fewer connections than younger brains. This explains the memory losses and decrease in emotional resiliency in older adults she said.
An earlier study last month came from another set of researchers led by University of California San Francisco researcher Arturo Alvarez-Buylla. The study titled, “Human hippocampal neurogenesis drops sharply in children to undetectable levels in adults,” was published first week of March this year in the journal Nature.
The team found that after adolescence there is little or no neurogenesis in the brain. They examined the brains of 17 deceased individuals and 12 patients with epilepsy part of whose brains had been surgically resected. The debate between the two teams continues. Boldrini explained that Buylla’s team had examined different types of samples that were not preserved as her samples had been.
Further the other team examined three to five sections of the hippocampus and not the whole of it she explained. More studies on this needed to make concrete conclusions regarding neurogenesis in the elderly say experts.