Posts Tagged Drugs

[WEB] Taking epilepsy drugs during pregnancy is not linked to cognitive problems in babies

Reviewed by Emily Henderson, B.Sc. Jun 8 2021

New findings published in JAMA Neurology suggest there is no difference in cognitive outcomes at age 2 among children of healthy women and children of women with epilepsy who took antiseizure medication during pregnancy.

The findings are part of the large research project Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD), which is a prospective, long-term study looking at outcomes in pregnant women with epilepsy and their children. The study was funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

This study reports findings from 382 children (292 children born to women with epilepsy and 90 born to healthy women) who were assessed for language development at age 2. The researchers also compared developmental scores with third trimester blood levels of antiseizure medication in these children.

Results suggest that children born to healthy women and those born to women with epilepsy do not show significant differences in language development scores at age 2. Neither was language development linked to third trimester blood levels of epilepsy medications. Most women with epilepsy in the study were taking lamotrigine and/or levetiracetam.

However, the study did find that those children born to mothers with the very highest levels of antiseizure medication in the blood during the third trimester did have somewhat lower scores on tests in the motor and general adaptive domains, which refer to skills related to self-care, such as feeding.

The children in this study will continue to be followed and will participate in additional cognitive tests through age 6. Results so far indicate that controlling epilepsy with these medications during pregnancy may be safe for babies.

Source: NIH/National Institute of Neurological Disorders and Stroke

Journal reference: Meador, K. J., et al. (2021) Two-Year-Old Cognitive Outcomes in Children of Pregnant Women With Epilepsy in the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs Study. JAMA Neurologydoi.org/10.1001/jamaneurol.2021.1583.

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[NEWS] ‘The Virtual Brain’: A new tool for epilepsy surgery planning

Reviewed by Emily Henderson, B.Sc. Feb 20 2021

Epilepsy is one of the most common neurological disorders, affecting over 50 Million people worldwide. Patients suffer from seizures caused by sudden neuronal activity engaging at times large networks of the brain. In a third of all cases the disease is resistant to drugs. The most common treatment option for these patients is surgical removal of the “epileptogenic zone”, the areas of the brain, where the seizures emerge.

“Surgery success depends on locating these areas as precisely as possible. But in clinical practice, this often proves very difficult, and the average surgery success rate remains at only around 60%”, says Viktor Jirsa. Any improvement would have major impact for many patients”.

The scientist has developed a computational tool, called “The Virtual Brain” (TVB), to model and predict activity in an individual patient brain. In collaboration with the neurologist Fabrice Bartolomei, they adapted the model to epilepsy, simulating the spread of individual seizure activity. The model thus can become an additional advisory tool for neurosurgeons to help target surgeries more precisely.

A clinical trial is currently underway to evaluate the personalized brain models of TVB as a new tool for epilepsy surgery planning, with promising first results. It is important to underscore that the Virtual Brain tool is still at clinical investigating stage and is therefore not yet available to patients.

The team now works on the next generation of The Virtual Brain, which boosts the accuracy of the model further using the EBRAINS research infrastructure. The objective is to significantly scale up the potential for personalized brain representation with the help of large brain data sets from the EBRAINS Brain Atlas. This includes the most detailed 3D representation of the brain’s anatomy, the BigBrain, at a resolution of 20 micrometers.

“Only EBRAINS allows to go to this massive scale and resolution”, Jirsa says. “Here brain data resources are made compatible and integrated with high-performance computing and informatics tools. EBRAINS enables the application of deep learning and other methods to find the configuration that most closely matches the patient’s own recordings of brain dynamics. This is an important step towards pinpointing the epileptogenic zone with greater precision.”

Katrin Amunts, Scientific Research Director of the HBP says: “The HBP’s multidisciplinary approach, gaining neuroscientific insight from the analysis of big data and neuroimaging studies, supported by brain modeling and advanced computing is a highly impactful way to advance brain research and bring innovation to patients and society.”

Pawel Swieboda, CEO of EBRAINS and Director General of the HBP, comments: “Prof Jirsa’s Virtual Brain computing tool is one of the many breakthrough achievements resulting from the cutting-edge scientific expertise of the Human Brain Project scientists and from the state-of-the art research infrastructure EBRAINS. We’re looking forward to sharing more brain health advances enabled by EBRAINS in the future. Meanwhile we invite researchers in different fields, such as neuroscience, neuroengineering, or neurotechnology – to list a few – to explore how the EBRAINS platform can enhance their own research.”

Source: Human Brain Project

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[NEWS] Researchers develop a technique to predict epileptic seizures

Reviewed by Emily Henderson, B.Sc. Dec 18 2020

A third of epilepsy sufferers are resistant to treatment for this neurological disease that affects 1% of the population. The onset of seizures is unpredictable, and has been the subject of fruitless research since the 1970s. The unforeseeable nature of the disease means patients are forced to take medication and / or adjust their lifestyles.

Neuroscientists from the University of Geneva (UNIGE) and the University Hospital of Bern (Inselspital) – working with the University of California in San Francisco (UCSF) and Brown University in Providence – have succeeded in developing a technique that can predict seizures between one and several days in advance. By recording neuronal activity over at least six months using a device implanted directly in the brain, it is possible to detect individual cycles of epileptic activity and provide information about the probability of a future seizure. This approach, published in the journal Lancet Neurology, is remarkably reliable, and prospective clinical trials are now in the pipeline.

An epileptic brain can switch suddenly from a physiological state to a pathological state, characterized by a disturbance of neuronal activity which can cause, inter alia, convulsions typical of an epileptic seizure. How and why the brain swaps one state for another is still poorly understood, with the result that the onset of a seizure is difficult, if not impossible, to predict.

Specialists worldwide have been trying for over 50 years to predict seizures a few minutes in advance, but with limited success.”

Timothée Proix, Researcher, Department of Fundamental Neurosciences, University of Geneva Faculty of Medicine

Seizures do not appear to be preceded by any obvious warning signs that would make prediction easier. The frequency, depending on the individual, varies from once a year to once a day.

“It’s a huge problem for patients”, begins Maxime Baud, a neurologist at Inselspital. “This unpredictability is associated with a permanent threat that obliges patients to take medication on a daily basis. And in many cases, it prevents them from participating in certain sports. Living with this hanging over you can also affect your mental health”. Existing treatments are often difficult to bear: they depend on drugs with numerous potential side effects to reduce neuronal excitability and sometimes involve neurosurgery to remove the epileptic focus, i.e. the starting point of the brain seizures. Moreover, a quarter of patients do not respond to these treatments, meaning they have to learn to manage the chronicity of their disease.

Weather forecasting

Epileptic activity can be measured using cerebral electrical activity data recorded by electroencephalography. This can be used to identify interictal discharges – evanescent discharges that appear in between seizures without directly causing them. “We observe clinically that epileptic seizures recur in clusters and cyclically. To ascertain whether the interictal discharges can explain these cycles and forecast the onset of a seizure, we analyzed the data in greater detail,” continues Dr Baud.

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To do this, Baud collaborated with Vikram Rao, neurologist at UCSF, to obtain neuronal activity data collected over several years using devices implanted long-term in the brains of patients with epilepsy. After confirming that there were indeed cycles of cerebral epileptic activity, the scientists turned their attention to statistical analysis.

This approach helped highlight a phenomenon known as the “pro-ictal state” where the probability of the onset of a seizure is high. “As with weather disturbances, there are several time scales in epileptic brain activity”, points out Dr Baud. “The weather is influenced by the cycle of the seasons or day and night. On an intermediate scale, when a weather front approaches, the probability that it will rain increases for several days and is, therefore, better predictable. These three scales of cyclic regulation also exist for epilepsy.”

The right timeframe

The electrical activity in the brain is a reflection of the cellular activity of its neurons, more precisely their action potentials, electrical signals propagating along the neural network to transmit information. Action potentials are well known to neuroscientists, and their probability can be modelled using mathematical laws. “We adapted these mathematical models to the epileptic discharges to find out whether they heralded or inhibited a seizure”, explains Dr Proix.

To boost the predictive reliability, recordings of brain activity over very long periods were required. Using this approach, fronts with a high probability of seizure lasting several days could be determined for a majority of patients, making it possible to predict seizures several days in advance in some. With brain activity data collected over periods of at least six months, seizure prediction is informative for two-thirds of patients.

The analytical approach is sufficiently “light” to allow the transmission of data in real time on a server or directly on a microprocessor with a device small enough to be implanted in the skull. The researchers are now working in collaboration with the Wyss Center for Bio and Neuroengineering, based at Campus Biotech in Geneva, to develop a minimally invasive brain monitoring device to record the long-term data needed to forecast seizures. The device, which slips under the skin of the scalp, could give people with epilepsy the power to plan their lives according to the likelihood of having a seizure.

Source: University of Geneva

Journal reference: Proix, T., et al. (2020) Forecasting seizure risk in adults with focal epilepsy: a development and validation study. Lancet Neurologydoi.org/10.1016/S1474-4422(20)30396-3.

Tags: BrainDrugsEpilepsyEpileptic SeizureFrequencyHospitalMedicineMental HealthNeurological DiseaseNeurologyNeuronsNeurosurgeryResearchSeizureSkin

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[WEB PAGE] 5 Things You Should Know About Substance Use After Brain Injury – BrainLine

Ohio Valley Center for Brain Injury Prevention and Rehabilitation

5 Things You Should Know About Substance Use After Brain Injury

If you or someone you care about has a brain injury, learning about the effects of substance use with brain injury is an important first step toward improving the chances for recovery.

Why do so many individuals with brain injury have problems with substance use?

Substance use problems prior to injury

Many people with brain injury have problems with the use of alcohol or other drugs prior to their injuries. It is not surprising that there is a strong link between being intoxicated and having a serious injury. Being intoxicated puts a person at greater risk for a brain injury due to problems with motor control, blurred vision, and poor decision-making. People who are intoxicated are also at greater risk of being victimized. Even adolescents and adults who are not intoxicated at the time of injury tend to be much heavier drinkers than their peers who have not had a brain injury. Up to 60% of those requiring inpatient rehabilitation for brain injury may have had prior problems with alcohol and other drug use. Individuals with these problems before the injury are at risk for even greater problems if they continue to drink or use drugs after the injury. 

New substance use problems after injury

In addition, some studies have shown that between 10% and 20% of persons with brain injury develop a substance use problem for the first time after their injury. A brain injury can lead some people to drink more alcohol or use more drugs than they intend. In comparison to others the same age, people with brain injury tend to drink more alcohol. 

After the honeymoon

Some people initially stop drinking or using drugs after the injury. They may recognize that the use of alcohol and other drugs will affect their recovery. The support of family and friends can also help people stay away from alcohol and other drugs. Unfortunately, after a while, some people start to drink or use drugs again. Many people think that it is ‘safe’ to use alcohol or other drugs after a certain amount of time has passed. However, there is no evidence indicating that there is a safe time to use.

How does alcohol and other drug use affect a person who has had a brain injury?

Persons with brain injury who use alcohol or other drugs show greater problems with brain structure and function.

1. Don’t Recover As Well

People who use alcohol or other drugs after they have a brain injury don’t recover as well.

2. Problems in Balance, Walking and Talking

Brain injuries cause problems in balance, walking or talking that get worse when a person uses alcohol or other drugs.

3. Say or Do Things Without Thinking First

People who have had a brain injury often say or do things without thinking first, a problem that is made worse by using alcohol and other drugs.

4. Problems With Thinking, Concentration or Memory

Brain injuries cause problems with thinking, concentration or memory, and using alcohol or other drugs makes these problems worse.

5. More Powerful Effect of Substances After brain injury

After a brain injury, alcohol and other drugs have a more powerful effect.

6. More Likely To Feel Low or Depressed

People who have had a brain injury are more likely to have times that they feel low or depressed and drinking alcohol and getting high on other drugs makes this worse.

7. Can Cause a Seizure

After a brain injury, drinking alcohol or using other drugs can cause a seizure.

8. More Likely To Have Another brain injury

People who drink alcohol or use other drugs after a brain injury are more likely to have another brain injury.

Other reasons to avoid alcohol and other drugs

In addition, persons with brain injury who use substances are more likely to experience:

  • Unemployment
  • Living alone
  • Feeling isolated
  • Lower life satisfaction
  • Interactions with prescribed drugs or other medical conditions
  • Criminal activity and being arrested
  • Injury or being victimized
  • Additional brain damage

How much alcohol is safe after brain injury?

Some people are surprised by how little is considered to be a safe amount to consume, even for people without brain injury. Based on what we know about how alcohol and traumatic brain injury add together to change brain structure and function, we believe that there is no safe amount after brain injury. We suspect that alcohol and other drugs can interfere with natural healing after a brain injury. The effects of substance use are more severe for individuals with brain injury and can result in further brain damage. We also believe that substance use can have an impact on how a person is functioning many years after the injury.

When to seek help

Many people benefit from professional help when their drinking or other drug use is too much and is creating problems for them. One sign that a person could use some assistance is when they have tried to cut down on their own, but somehow the problem continues. Another sign is when people who care about a person begin worrying that he or she is drinking too much. Finally, if a person is facing legal or medical problems due to use (including having another injury) it is advisable to seek help. 

A tool to assess use is available at Rethinkingdrinking.niaaa.nih.gov

What is appropriate substance use treatment for a person with brain injury?

Impairments caused by brain injury may present unique obstacles to treatment success. There has not been very much research about which substance abuse treatment methods work best for people who have had brain injuries. Most clinicians feel that techniques found effective for people in general can also be effective for people who have had brain injuries. However, it is important to find a treatment provider who is willing to to take into consideration the special needs of the person with brain injury.

Involving family and friends

Substance abuse treatment often includes both the individual and family or friends. The greater a person’s cognitive impairments after brain injury, the more important it becomes that people in his or her surroundings are willing to be involved in the treatment process. Similarly, for people who do not see themselves as having a problem, it is more important that family and friends be willing to join professionals to get a person started in addressing their substance use.

Accommodating symptoms of brain injury in treatment

Special considerations or accommodations may be needed to make the treatment useful and effective. It is important that the substance use counselor understand the unique challenges that persons with brain injury face in substance use treatment. It may be helpful to share the following information with your counselor:

Stages of change

How ready a person is to address problems related to their alcohol or other drug use can be described in the following stages:

  1. Precontemplation (a person sees no problem with his or her alcohol or other drug use when there is one)
  2. Contemplation (the person is weighing the pros and cons of changing substance use)
  3. Preparation (the person has decided that a change is needed, but does not yet have a specific goal)
  4. Action (the person is making changes in order to reduce or eliminate the use of alcohol and other drugs)
  5. Maintenance (the person is sustaining successful change despite urges to use again). 

Substance abuse counselors usually tailor treatment to a person’s Stage of Change. Regardless of a person’s readiness to address an alcohol or other drug use problem, there is always something a professional substance abuse counselor or treatment program can provide.

Treatment methods for substance use problems

Effective treatment is usually tailored to a person’s readiness to address substance use problems. To be effective, the treatment method chosen must be acceptable to the person being treated.

Treatment method options may include:

  • Motivational interventions
  • Cognitive-behavioral therapy
  • Therapeutic communities
  • Prescription medications
  • Self-help groups

treatment facility locator tool developed by SAMHSA can help you find treatment at a location near you.

Living in recovery

Learning about the effects of alcohol and other drugs after brain injury can help people to make choices that will help them to recover more fully. Family and friends can help support an alcohol and drug-free lifestyle. People can also obtain support through treatment. We believe that people can continue to show improvements for several years after a brain injury, as long as they are living a healthy lifestyle, which includes avoiding alcohol and other drugs.

Posted on BrainLine July 26, 2018. Reviewed July 26, 2018.

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[WEB PAGE] Mozart’s piano music can reduce the frequency of epilepsy attacks

A new comprehensive analysis on the effect of Mozart’s music on epilepsy has confirmed that listening to his piano music can reduce the frequency of epilepsy attacks. The results of this comprehensive meta-analysis (a study of studies), which may overturn current scepticism about the effect, are presented at the ECNP congress after recent publication in a peer-reviewed journal.

The idea that listening to Mozart may have beneficial effects on mental health arose from early findings in the 1990s. There have been several studies since, but many involved small numbers of people, or have been of variable quality, leading to mixed evidence overall. This has meant that the “Mozart Effect” has been treated with some scepticism by many clinicians.

Now two Italian Researchers, Dr Gianluca Sesso and Dr Federico Sicca from the University of Pisa have conducted a systematic review of works related to the effect of Mozart’s music on epilepsy.

Working according to accepted standard methods for analysing clinical treatment, they looked at 147 published research articles, which they then evaluated according to such things are relevance and quality of the research. This allowed them to select 12 pieces of research which they gathered into 9 separate groups, representing the best available science on the effect of Mozart’s music on epilepsy.

They found that listening to Mozart, especially on a daily basis, led to a significant reduction in epileptic seizures, and also to a reduced frequency of abnormal brain activities in epileptic patients (called interictal epileptiform discharges, which are commonly seen in epileptic patients). These effects occurred after a single listening session and were maintained after a prolonged period of treatment.

Gianluca Sesso said “This isn’t the first such review of the effect of Mozart’s music on epilepsy, but there has been a flow of new research in the last few years, so it was time to stand back and look at the overall picture. The design of the studies varies, for example some people look at a single listening session, others at daily listening sessions, so it’s not easy to form a conclusion.


Epilepsy is surprisingly common, affecting just under 1 person in a hundred worldwide. This means that it has significant social and personal costs. Mostly it’s treated by drugs, but these drugs don’t work in around 30% of patients, so we need to be open to other therapies: the important thing is that these therapies can be tested and shown to work, and this is what we have shown here”.

The meta-analysis indicates that a period of listening to Mozart can give an average reduction in epileptic seizures ranging from between 31% to 66%, but this varies from person to person and according to the music stimulus used. The original studies on the Mozart Effect used the sonata for 2 pianos, K448, and this has remained the music most used in studies. The K545 piano sonata has also been shown to have an effect.

Dr Sesso said “All cultures have music, so it obviously fulfils some psychological need. The mechanisms of the Mozart Effect are poorly understood. Obviously other music may have similar effects, but it may be that Mozart’s sonatas have distinctive rhythmic structures which are particularly suited to working on epilepsy. This may involve several brain systems, but this would need to be proven.

This is a review of research, and not original research. One thing it shows is that we need more consistent studies into the effect of music on the mind”

Commenting, Dr Vesta Steibliene, Lithuanian University of Health Sciences, and member of the ECNP Abstract and Poster Committee said:

“There is growing interest in non-invasive brain stimulation techniquesin the treatment of neuropsychiatric disorders. This review revealed that Mozart music could be an effective non-invasive method of neurostimulation, reducing the frequency of epileptic seizures, even in hard to treat patients. However, in order to use this method in clinical settings, the exact mechanism of the Mozart music effect on the brain regions should be better understood”.

Source: European College of Neuropsychopharmacology (ECNP)

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[WEB PAGE] Study reveals three effective treatments to stop epilepsy seizures

 

There are effective treatments to stop life-threatening epilepsy seizures when the initial treatment has failed, a sweeping new study reveals.

The study offers important answers about three such emergency drugs that are used to treat prolonged seizures, known as status epilepticus, even though physicians have had little understanding of the drugs’ effectiveness. Until now, there has been no clear indication of which is best or how much should be given.

The study found that the three drugs – intravenous levetiracetam, fosphenytoin, and valproate – were all about equally effective at stopping the potentially deadly seizures when the default choice, benzodiazepines, proved unable to do so. The results were so clear that the shocked researchers stopped their trial early.

When we planned the study, we didn’t even know if these drugs work 10%, 25% or 50% of the time. So the big, big takeaway is that each of these drugs works about 45 percent of the time. And this is an important finding because it tells us patients can get better. They don’t have to be placed on a on a ventilator [breathing machine].”

Jaideep Kapur, MBBS, PhD, investigator and the head of the University of Virginia Brain Institute

Effect on Clinical Practice

The study’s findings, published in the prestigious New England Journal of Medicine, both affirm existing clinical practices and suggest a major change.

Doctors can feel confident that their preferred drug of choice is as effective as the other options, Kapur noted, but they also should significantly increase how much levetiracetam they give when they choose it.

“Prior to this, people were using their best guess as to which drug to use and how much of it to use. And this puts those things to rest and tells you exactly how much of which to use, and what to expect,” said Kapur, of the UVA School of Medicine’s Department of Neurology.

The trial organizers tested the maximum safe dose of each of the drugs so there would be no question whether too little had been used to gauge the medicine’s effectiveness. In so doing, they gave twice as much levetiracetam as many doctors administer.

“When I started 25 years ago, there was not a single scientifically proven drug [for status epilepticus]. We didn’t know which drug to use, even for the first-line treatment, and how much of them to use,” Kapur said. “And 25 years later, we can treat more than 80% of the patients – 85% of the patients – using scientifically proven drugs. 85% of our patients will get better, will stop having seizures and start waking up. That is the effect of scientific research on improving care of patients, and this is real.”

About the Epilepsy Seizure Trial

The randomized, double-blinded trial looked at the effect of the drugs in 384 patients at 57 emergency departments in the United States between November 2015 and the end of October 2017.

The researchers originally planned to study 795 patients over five years, but the results were so clear that was deemed unnecessary. “Clinical trials are notorious for going over long and over budget, and we came in under budget,” Kapur said.

That was possible, he said, because of the participation of many top experts in both the United States and Europe. Participating sites included the University of Michigan, Medical University of South Carolina, UVA, Children’s National Medical Center in Washington, D.C., and many more.

“It was an amazingly accomplished group of people,” Kapur said. “We had the best experts from all over the United States and Europe. For me, it’s been a great joy working with the team as the leader of the Brain Institute. That’s the spirit I want to bring to UVA. That’s really what motivated me to start the Brain Institute: to fashion these teams within UVA, so that we can do really significant, societally impactful research.”

UVA Emergency Medicine physician Stephen Huff, MD, led the study at the UVA site, which enrolled seven subjects. Amy Fansler, Emily Gray and Lea Becker helped organize the study.

Kapur expressed his gratitute to all the patients who participated in the study. “President Ryan [UVA President Jim Ryan] has said we must be great and good,” Kapur said, “and this is the kind of good we want to do.”

Next Steps

The researchers are now looking more closely at the drugs’ effectiveness and dosing in children. That will offer important information on how best to treat the young patients, as the causes of status epilepticus in adults and children often differ.

 

via Study reveals three effective treatments to stop epilepsy seizures

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[Abstract] Pharmacological interventions and rehabilitation approach for enhancing brain self-repair and stroke recovery

Abstract

Neuroplasticity is a natural process occurring in the brain for entire life. Stroke is the leading cause of long term disability and huge medical and financial problem throughout the world. Research conducted over the past decade focused mainly on neuroprotection in the acute phase of stroke while very little studies targets chronic stage. Recovery after stroke depends on the ability of our brain to reestablish structural and functional organization of neurovascular networks. Combining adjuvant therapies and drugs may enhance the repair processes and restore impaired brain functions. Currently, there are some drugs and rehabilitative strategies that can facilitate brain repair and improve clinical effect even years after stroke onset. Moreover, some of compounds such as citicoline, fluoxetine, niacin, levodopa etc. are already in clinical use or are being trial in clinical issues. Many studies testing also cell therapies, in our review we will focused on studies where cells have been implemented at the early stage of stroke. Next, we discuss pharmaceutical interventions. In this section selected methods of cognitive, behavioral and physical rehabilitation as well as adjuvant interventions for neuroprotection including non invasive brain stimulation and extremely low frequency electromagnetic field. The modern rehabilitation represents new model of physical interventions with limited therapeutic window up to six months after stroke. However, last studies suggest, that time window for stroke recovery is much longer than previous thought. This review attempts to present the progress in neuroprotective strategies, both pharmacological and non-pharmacological that can stimulate the endogenous neuroplasticity in post stroke patients.

 

via Pharmacological interventions and rehabilitation approach for enhancing brain self-repair and stroke recovery | Bentham Science

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[WEB SITE] List of Seizures (Convulsions) Medications (60 Compared) – Drugs.com

Medications for Seizures (Convulsions)

Other names: Absence Seizure; Complex Partial Seizure; Fits

About Seizures:  A seizure or convulsion can be a sudden, violent, uncontrollable contraction of a group of muscles. A seizure can also be more subtle, consisting of only a brief “loss of contact” or a few moments of what appears to be daydreaming.

 

Drugs Used to Treat Seizures

The following list of medications are in some way related to, or used in the treatment of this condition.[…]

For the list of medications, Visit Site —> List of Seizures (Convulsions) Medications (60 Compared) – Drugs.com

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[WEB SITE] FDA approves marijuana based medication for epilepsy treatment

 

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.

Marijuana plant flowering outdoors. Image Credit: Yarygin / Shutterstock

Marijuana plant flowering outdoors. Image Credit: Yarygin / Shutterstock

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.

Reference: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM604736.pdf

 

via FDA approves marijuana based medication for epilepsy treatment

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[WEB SITE] Largest-ever study to examine anatomical alterations in the brains of epilepsy patients

Largest-ever study to examine anatomical alterations in the brains of epilepsy patients 

An international research consortium used neuroimaging techniques to analyze the brains of more than 3,800 volunteers in different countries. The largest study of its kind ever conducted set out to investigate anatomical similarities and differences in the brains of individuals with different types of epilepsy and to seek markers that could help with prognosis and treatment.

Epilepsy’s seizure frequency and severity, as well as the patient’s response to drug therapy, vary with the part of the brain affected and other poorly understood factors. Data from the scientific literature suggests that roughly one-third of patients do not respond well to anti-epileptic drugs. Research has shown that these individuals are more likely to develop cognitive and behavioral impairments over the years.

The new study was conducted by a specific working group within an international consortium called ENIGMA, short for Enhancing NeuroImaging Genetics through Meta-Analysis, established to investigate several neurological and psychiatric diseases. Twenty-four cross-sectional samples from 14 countries were included in the epilepsy study.

Altogether, the study included data for 2,149 people with epilepsy and 1,727 healthy control subjects (with no neurological or psychiatric disorders). The Brazilian Research Institute for Neuroscience and Neurotechnology (BRAINN), which participated in the multicenter study, was the center with the largest sample, comprising 291 patients and 398 controls. Hosted in Brazil, at the State University of Campinas (UNICAMP), BRAINN is a Research, Innovation and Dissemination Center (RIDC http://cepid.fapesp.br/en/home/) supported by the Sao Paulo Research Foundation – FAPESP.

“Each center was responsible for collecting and analyzing data on its own patients. All the material was then sent to the University of Southern California’s Imaging Genetics Center in the US, which consolidated the results and performed a meta-analysis,” said Fernando Cendes, a professor at UNICAMP and coordinator of BRAINN.

A differential study

All volunteers were subjected to MRI scans. According to Cendes, a specific protocol was used to acquire three-dimensional images. “This permitted image post-processing with the aid of computer software, which segmented the images into thousands of anatomical points for individual assessment and comparison,” he said.

According to the researcher, advances in neuroimaging techniques have enabled the detection of structural alterations in the brains of people with epilepsy that hadn’t been noticed previously.

Cendes also highlighted that this is the first epilepsy study built on a really large number of patients, which allowed researchers to obtain more robust data. “There were many discrepancies in earlier studies, which comprised a few dozen or hundred volunteers.”

The patients included in the study were divided into four subgroups: mesial temporal lobe epilepsy (MTLE) with left hippocampal sclerosis, MTLE with right hippocampal sclerosis, idiopathic (genetic) generalized epilepsy, and a fourth group comprising various less common subtypes of the disease.

The analysis covered both patients who had had epilepsy for years and patients who had been diagnosed recently. According to Cendes, the analysis – whose results were published in the international journal Brain – aimed at the identification of atrophied brain regions in which the cortical thickness was smaller than in the control group.

First analysis

The researchers first analyzed data from the four patient subgroups as a whole and compared them with the controls to determine whether there were anatomical alterations common to all forms of epilepsy. “We found that all four subgroups displayed atrophy in areas of the sensitive-motor cortex and also in some parts of the frontal lobe,” Cendes said.

“Ordinary MRI scans don’t show anatomical alterations in cases of genetic generalized epilepsy,” Cendes said. “One of the goals of this study was to confirm whether areas of atrophy also occur in these patients. We found that they do.”

This finding, he added, shows that in the case of MTLE, there are alterations in regions other than those in which seizures are produced (the hippocampus, parahippocampus, and amygdala). Brain impairment is, therefore, more extensive than previously thought.

Cendes also noted that a larger proportion of the brain was compromised in patients who had had the disease for longer. “This reinforces the hypothesis that more brain regions atrophy and more cognitive impairment occurs as the disease progresses.”

The next step was a separate analysis of each patient subgroup in search of alterations that characterize each form of the disease. The findings confirmed, for example, that MTLE with left hippocampal sclerosis is associated with alterations in different neuronal circuits from those associated with MTLE with right hippocampal sclerosis.

“Temporal lobe epilepsy occurs in a specific brain region and is therefore termed a focal form of the disease. It’s also the most common treatment-refractory subtype of epilepsy in adults,” Cendes said. “We know it has different and more severe effects when it involves the left hemisphere than the right. They’re different diseases.”

“These two forms of the disease are not mere mirror-images of each other,” he said. “When the left hemisphere is involved, the seizures are more intense and diffuse. It used to be thought that this happened because the left hemisphere is dominant for language, but this doesn’t appear to be the only reason. Somehow, it’s more vulnerable than the right hemisphere.”

In the GGE group, the researchers observed atrophy in the thalamus, a central deep-lying brain region above the hypothalamus, and in the motor cortex. “These are subtle alterations but were observed in patients with epilepsy and not in the controls,” Cendes said.

Genetic generalized epilepsies (GGEs) may involve all brain regions but can usually be controlled by drugs and are less damaging to patients.

Future developments

From the vantage point of the coordinator for the FAPESP-funded center, the findings published in the article will benefit research in the area and will also have future implications for the diagnosis of the disease. In parallel with their anatomical analysis, the group is also evaluating genetic alterations that may explain certain hereditary patterns in brain atrophy. The results of this genetic analysis will be published soon.

“If we know there are more or less specific signatures of the different epileptic subtypes, instead of looking for alterations everywhere in the brain, we can focus on suspect regions, reducing cost, saving time and bolstering the statistical power of the analysis. Next, we’ll be able to correlate these alterations with cognitive and behavioral dysfunction,” Cendes said.

 

via Largest-ever study to examine anatomical alterations in the brains of epilepsy patients

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