Mayo Clinic Finds Seizure Generation in Brain is Isolated from Surrounding Brain Regions

Mayo Clinic researchers found that the part of the brain generating seizures in individuals with epilepsy is functionally isolated from surrounding brain regions. The researchers hope this finding could be a clinical biomarker to help identify individuals with abnormal brain function. This study was presented at the American Epilepsy Society's annual meeting in San Antonio on Dec. 4.

Epilepsy is a disorder characterized by the occurrence of two or more seizures. It affects almost 3 million Americans.

"The synchronization of local and distributed neuronal assemblies underlies fundamental brain processes like perception, learning and cognition," says Gregory Worrell, M.D., Ph.D., a Mayo Clinic epileptologist and an author of this study. "In neurological disease, neuronal synchrony can be altered, and in epilepsy the synchrony plays an important role in the generation of seizures."

Mayo Clinic researchers investigated neuronal synchrony by studying intracranial EEG (electroencephalogram) recordings from patients with epilepsy and control subjects with facial pain. Researchers discovered that the control patients had greater average synchrony than patients with focal epilepsy (when seizures are produced in a small part of the brain, not the entire brain). When implanted electrode pairs bridged seizure-generating brain and other brain regions, the synchrony was significantly less than between other electrode pairs in the epileptic brain and the control brain. The team also found that with greater activity in the seizure-generating region, there was less synchrony with neighboring tissue outside that region.

"Our study shows us that the part of the brain generating seizures is isolated from the surrounding brain regions," says Dr. Worrell. "This finding could serve as a clinical biomarker of an abnormal brain, and it can also be useful in epilepsy surgery and brain stimulation treatments, as well as helping us understand how seizures are generated." Other scientists involved in this research include C. Warren, Ph.D.; S. Hu; S. Stead, M.D., Ph.D.; B. Brinkmann, and M. Bower, Ph.
---
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
Facebook: http://facebook.com/ArtsAcrossGA
www.FayetteFrontPage.com
Twitter: @FayetteFP

Home-Based Mindfulness Treatment Curbs Depression in Adults With Epilepsy

A telephone- and Internet-delivered mindfulness-based depression treatment has been shown to significantly reduce depressive symptoms in adults with epilepsy, according to a study by Emory University public health researchers, published in the November 2010 issue of Epilepsy & Behavior.

The treatment called UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based depression prevention and treatment program. Based on mindfulness-based cognitive therapy, the weekly program was designed for group delivery via the phone or Web. It involves eight, hour-long sessions focused on increasing knowledge about depression, epilepsy, cognitive-behavioral therapy (CBT) and mindfulness.

Forty participants were randomly assigned to participate in the intervention or waitlist groups. Depressive symptoms and other outcomes were measured at baseline, after eight weeks, and after 16 weeks.

Depressive symptoms decreased by 64 percent in the intervention group but only by 15 percent in the waitlist group. There was no significant difference in results between participants who received the intervention via telephone or Internet.

“The Project UPLIFT intervention was effective in teaching people with epilepsy the knowledge and skills associated with reducing their symptoms of depression,” says lead study author Nancy Thompson, PhD, associate professor of behavioral science and health education at Emory’s Rollins School of Public Health. “Addressing the mental health needs of this population is important as many people with epilepsy – between 32 percent and 48 percent – report being depressed as well as feeling isolated and stigmatized.”

Future studies of the UPLIFT program will target other populations at risk of depression, such as caregivers or persons with disabilities, who may benefit from a home-based treatment. The U.S. Centers for Disease Control and Prevention funded the Project UPLIFT pilot study.

In addition to Thompson, study authors were Elizabeth Reisinger Walker, Natasha Obolensky, Ashley Winning, Christina Barmon, and Colleen Dilorio, of the Rollins School of Public Health; and Michael Compton of the Emory School of Medicine.


-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

Epilepsy Organizations Award Grants for New Gene Therapy to Treat Epilepsy and Novel Surgical Intracranial EEG to Detect Seizures in Uncontrolled Patients

/PRNewswire/ -- The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced the latest grant recipients of its New Therapy Grants Program, a unique joint venture of the non-profit epilepsy organizations, to advance promising epilepsy research in clinical development. The grant awards, totaling approximately $200,000 in funding, will support an experimental gene therapy that directly targets epileptogenic brain tissue, as well as an electrode system that has the potential to improve the efficacy of surgical therapies for certain epilepsy syndromes.

"Patients need new options to treat and manage epilepsy, and through this grant program we are excited to see such remarkable innovation in the field. The fields of gene therapy and surgical treatment of epilepsy remain cutting-edge with much to be explored in terms of advancing epilepsy treatment outcomes," said Orrin Devinsky, MD, ETP Co-Founder and Vice President for Translational Programs, Professor of Neurology, Neurosurgery, and Psychiatry, and Director, NYU Comprehensive Epilepsy Center, New York University. "By choosing to support these two promising programs, we hope to see important strides made while encouraging researchers and companies to pursue new ideas and approaches in epilepsy and seizure conditions."

The New Therapy Grants program grants are designated to facilitate the advancement of new treatments through critical early-stage clinical development or to bridge the gap from preclinical to clinical development to ensure patients will have the opportunity to benefit from groundbreaking progress in the field of epilepsy. The award committee, which is comprised of clinical, scientific and industry representatives, evaluates applications to support new therapeutic approaches submitted by highly qualified clinical experts and scientists with the greatest potential for near-term patient benefit.

"The need and market opportunity for new therapies in epilepsy is unmistakable," said Warren Lammert, Chairman of the Epilepsy Therapy Project. "One third of the people with epilepsy live with uncontrolled seizures despite all available therapies and perhaps another one third achieve seizure control but at the price of unacceptable side-effects including fatigue and impact to cognition. Yet moving promising ideas out of research labs and on through the process of clinical and commercial development is an enormously expensive process with miniscule odds of success for each individual project. Further, epilepsy therapy development has been neglected by government and private funding sources, and current economic uncertainties have further diminished the availability of risk capital. In this environment, the importance of our New Therapy Grants in moving the most promising new research ideas across the starting line on to a path of clinical development cannot be overstated. My hope is that we can mobilize increased support and expand this vital program so necessary to improving the lives of people living with epilepsy."

"These research projects represent the essence of translational research and the focus of our New Therapy Grants Program," said Joyce Bender, chair of the Epilepsy Foundation board of directors. "We proudly applaud our grant recipients because their studies may provide new treatment options, which could lead to an improved quality of life for the nearly 3 million people in the United States and 50 million people worldwide living with epilepsy."

The Grant Recipients

Galanin Gene Delivery to the Hippocampus for Mesial Temporal Lobe Epilepsy

-- Prospect of one-time gene therapy that produces anti-convulsant and
neuroprotective benefits
-- Experimental therapy may offer less invasive therapeutic option and a
prospective paradigm shift in patient care for certain forms of
epilepsy


Scott McPhee, Ph.D., Vice President of Clinical Development, Asklepios BioPharmaceutical Inc., and Nicholas Boulis, M.D., Assistant Professor, Neurosurgery, Emory University, will be conducting preclinical studies of a Galanin gene delivery for selected patients with uncontrolled Mesial Temporal Lobe Epilepsy (MTLE). Direct delivery of a gene therapy to the temporal lobe offers the significant potential of a less invasive, more effective alternative approach that precludes the trauma and resulting complications of surgical tissue removal, and avoids the side effects of standard pharmacological treatments. The protein galanin has been shown to suppress seizures. Gene delivery of galanin DNA has been shown to have anticonvulsant and neuroprotective effects in models of MTLE. Unlike traditional anti-epileptic medications, galanin gene delivery may be administered in a one-time intervention that provides long-term supplemental galanin in the epileptogenic tissue. The proposed therapeutic approach represents a paradigm shift in the treatment of epilepsy because gene delivery offers to locally regulate activity rather than destroying tissue. In addition, it has the unique and significant potential to one day provide a strategy for the treatment of critical brain tissue in which tissue removal is not currently a therapeutic option. These experiments may not only provide a unique opportunity for the development of novel epilepsy therapies but may also advance the cause of neurological gene therapy in general.

The preclinical research outlined by the grant recipients is expected to support the filing of an

Investigational New Drug (IND) Application for a Phase I clinical trial. Funding of the preclinical protocol is subject to appropriate institutional review and approvals, as well as securing the additional financial support needed to complete the research.

Intracranial EEG Acquisition System with Online Fast Ripple Detection

-- New technology to refine how surgeons will identify and define
epileptogenic regions of the brain
-- Potential to improve surgical outcomes and broaden viability of
treatment for certain epilepsy syndromes


A Columbia University Medical Center research team headed by Catherine Schevon, M.D., Assistant Professor, Neurology, received funding to support the refinement of an intracranial EEG recording system, an online detection system to better define the epileptogenic region of the brain, the area of the brain related to seizure activity, before therapy or surgery.

Surgical excision of the epileptogenic brain region is an important treatment modality for medically refractory partial epilepsy, with greater than 60 percent or more of patients achieving seizure freedom. The success rate is notably worse, however, when a structural lesion cannot be identified, and may be as low as 35 percent in patients with extratemporal non-lesional syndromes. In these cases, the resection choice depends almost entirely on accurate interpretation of the intracranial EEG (iEEG), obtained by recording from electrodes implanted directly onto the brain surface or into the parenchyma. Recognizing these limitations surgical therapy for extratemporal epilepsy syndromes is not currently recommended for widespread clinical use.

High frequency oscillations (HFO) in the brain can identify areas for epilepsy surgery treatments, but are technically difficult to detect, largely limiting their clinical utility. Grant funding will be applied to the development of this new system to bring automatic online HFO detection into clinical practice, making current surgical treatments more effective, and potentially simplifying surgeries for many epilepsy syndromes. By increasing the specificity of the identification of the epileptogenic region, seizure outcomes can be improved while the area of brain that must be removed is minimized.

Upcoming Grant Applicants: Note Deadline for Letter of Intent is September 3, 2010

The New Therapy Grants Program is requesting proposals from scientific and clinical investigators pursuing innovative projects that demonstrate a clear path to commercialization. The program accepts the submission of proposals ranging from $50,000 to $500,000. The deadline to submit a Letter of Intent (LOI) is September 3, 2010. Applicants who have an accepted LOI have until October 15, 2010, to submit their full proposals. To view additional requirements, please visit http://www.epilepsy.com/etp/support_translational.

The New Therapy Grants Program is a unique partnership between two leading epilepsy non-profit organizations, the Epilepsy Therapy Project and the Epilepsy Foundation. The mission of the New Therapy Grants Program is to drive the development of new therapies for epilepsy, accelerating the advancement of research from the laboratory to the patient. Funding is provided for grants supporting the research and development of new therapies in both academic and commercial settings worldwide.

-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures

Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.

“Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”

Infantile spasms consist primarily of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms. Infants may have dozens of clusters and several hundred spasms per day. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.

Epilepsy is a neurological condition that produces disturbances in the normal electrical functions of the brain, causing people to have recurring seizures. Seizures happen when nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscle jerking, which may be repetitive, or lose consciousness.

Damage to vision is an important safety concern with the use of Sabril. The drug will have a boxed warning to alert health care professionals to this risk of a progressive loss of peripheral vision with potential decrease in visual acuity. The risk of vision damage may increase based on the dosage and duration of use, but even the lowest doses of Sabril can cause vision damage. Periodic vision testing is required for those taking Sabril. Because of the risk of permanent vision damage, the drug will be available only through a restricted distribution program.

Sabril was designated as an orphan drug by the FDA for use in treating infantile spasms. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. Orphan drug status provides the company with financial incentives to promote the development of a drug to treat a rare disease or condition.

Sabril is made by Lundbeck Inc. of, Deerfield, Ill.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Approves New Drug to Treat Severe Form of Epilepsy

The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

"This approval offers another treatment option for patients who suffer from these debilitating, severe seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age, and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. In 30-35 percent of cases, no cause can be found. Patients may have periods of frequent seizures mixed with brief, relatively seizure-free periods; and suffer from varying types of seizures including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances.

In a single four-month clinical trial studying patients 4 to 30 years old, patients taking Banzel had improved seizure control when compared to those taking placebo. The observed effect was approximately a 41 percent reduction of tonic plus atonic seizure frequency over placebo and 20 percent reduction of total seizure frequency over placebo. In addition, overall improvement was reported as measured by a parent/guardian evaluation.

Common adverse reactions reported by patients using Banzel in clinical trials included headache, dizziness, fatigue, drowsiness, gait disturbance, double-vision, nausea and vomiting. Banzel's labeling will include a warning that antiepileptic drugs increase the risk of suicidal thoughts or behaviors in patients taking the drug for any indication. Patients taking antiepileptic drugs should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. This warning is based on the results of analyses performed by the FDA on nearly 200 controlled clinical trials with 11 FDA-approved antiepileptic drugs. Banzel was not included in these analyses, but the results are considered to apply to all chronically administered antiepileptic drugs, including Banzel. As discussed at a July 2008 public advisory committee meeting, the FDA is working with manufacturers of all antiepileptic drugs to include similar warning statements in prescribing information. The FDA is requiring that a patient Medication Guide be given to patients and caregivers when Banzel is dispensed. The Medication Guide will describe the risk of suicidal thoughts and behavior associated with the class of antiepileptic drugs.

Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J.

Banzel was granted orphan drug designation by the FDA. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects fewer than 200,000 people in the United States. This designation can also be extended to drugs for diseases or conditions that affect a larger number of patients if there is no reasonable expectation that the cost of developing such medications and making them available will be recovered from sales.

-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
www.georgiafrontpage.com
Georgia Front Page

Keppra XR(TM) Approved for Sale in US by FDA

Epilepsy is a chronic neurological disorder affecting approximately three million people in the US-making it more common than multiple sclerosis and Parkinson's disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes. Forty percent of patients taking only one AED continue to experience seizures, and approximately 30% of patients taking adjunctive therapy continue to experience seizures. This highlights the ongoing need for the development of new AEDs. For more information about epilepsy, visit www.epilepsyfoundation.org, www.epilepsy.com, or www.epilepsyadvocate.com.

PRNewswire --- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR(TM) (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older. Keppra XR(TM) is expected to be available in U.S. pharmacies at the end of September 2008.

The goal of therapy with antiepileptic drugs (AED) is freedom from seizures and minimal side effects. While many people with epilepsy are successfully treated with one or more of the currently available antiepileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects.

"With solid clinical trial data supporting Keppra XR(TM) efficacy and tolerability, this once-daily antiepileptic drug can play an important role in treating people with epilepsy," said lead investigator Dr. Jukka Peltola, Department of Neurology, Tampere University Hospital, Finland. "We found in the clinical trial that Keppra XR(TM) provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated."

Important Safety Information

Keppra XR(TM) extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediate- release Keppra(R) tablets.

Keppra(R) immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.

Keppra XR(TM) should be gradually withdrawn to minimize the potential of increased seizure frequency.

Dosing must be individualized according to the patient's renal function status. The dosage should be reduced in patients with impaired renal function receiving Keppra XR. In patients with end stage renal disease on dialysis, it is recommended that immediate-release Keppra(R) be used instead of Keppra XR(TM).

For full prescribing information, please see www.KeppraXR.com.

In order to ensure patient access to this valuable medication in the U.S., UCB is initiating a co-pay support program. For more information, contact U.S. UCB Medical Information at 1-866-822-0068 (press 9).

____
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Epilepsy.com Provides Seizure Information to Help Educate the Public

BUSINESS WIRE--Epilepsy.com, an award-winning patient care site, is providing accurate information regarding epilepsy and seizures to the public and the media in the wake of the reported seizure that hospitalized Senator Edward M. Kennedy (D-Mass) on May 17. The website www.epilepsy.com of which Harvard Medical School Professor of Neurology, Steven C. Schachter, MD, is Editor-in-Chief, is an online resource for more than 200,000 unique visitors and one million page views per month. Dr. Schachter is also Director of Research for the Department of Neurology at Beth Israel Deaconess Medical Center in Boston. We present here information and links to epilepsy.com that should be helpful in understanding this event.

What is a seizure? A seizure is a sudden surge of electrical activity in the brain that usually affects how a person feels or acts for a short time (http://my.epilepsy.com/101/ep101_seizure). Seizures are not a disease in themselves. Instead, they are a symptom of many different disorders that can affect the brain. Seizures can range from hardly noticeable to a convulsion (http://my.epilepsy.com/epilepsy/types_seizures).

What is epilepsy? Epilepsy is a neurological condition that affects the brain. Epilepsy is also known as a seizure disorder. Epilepsy is usually diagnosed after a person has had at least two seizures that were not caused by some non-neurological condition that secondarily affects the brain, such as extremely low blood sugar (http://my.epilepsy.com/101/ep101_epilepsy). Although epilepsy is often considered a disorder of childhood, it can begin at any age. The rate of newly diagnosed epilepsy is actually higher in seniors (elderly people) than in middle-aged adults.

What tests are usually performed when a person has their first seizure? Because there are many possible causes of seizures, a thorough medical history is obtained and a variety of medical tests are performed to determine the cause, if possible, and to evaluate the risk of further seizures. Among the tests typically done are blood tests, a test of the brainwaves called an electroencephalogram (EEG), and brain imaging tests such as CT and MRI scans (http://my.epilepsy.com/101/101_diagnosis). Very often, these tests do not reveal a cause.

What are the possible causes of seizures and epilepsy? There is a long list of possible causes (http://my.epilepsy.com/101/ep101_risks) because many of the conditions that affect brain function can possibly cause a seizure. The cause of recurrent seizures (epilepsy) that begin in later life cannot be determined in about half of the cases. Of those in whom the cause can be determined, the most common cause is strokes, including small ones that did not cause other symptoms.

When is treatment usually begun? If the medical evaluations and tests determine that a person has had more than one seizure, or that he or she is at substantial risk for a second seizure due to an identified problem with brain function, then therapy with medicines called “anticonvulsants” or “antiepileptic drugs” may be started (http://my.epilepsy.com/epilepsy/treatment; http://my.epilepsy.com/info/seniors_effectsmed).

What is appropriate first aid for seizures? Here are a few things you can do to help someone who is having a seizure of any kind (http://my.epilepsy.com/epilepsy/firstaid):

• Stay calm.
• Prevent injury. Move anything away that could harm the person if he or she struck it.
• Pay attention to the length of the seizure.
• Make the person as comfortable as possible.
• Keep onlookers away.
• Do not hold the person down.
• Do not put anything in the person's mouth. Contrary to popular belief, a person having a seizure is incapable of swallowing their tongue so don’t put your fingers or any object into the mouth of someone having a seizure.
• Do not give the person water, pills, or food until fully alert.
• If this is the first known seizure for the person, or it lasts more than five minutes, or there is an apparent injury, call 911.
• Be sensitive and supportive, and ask others to do the same.

The mission of epilepsy.com is to inform and empower patients and families facing newly diagnosed epilepsy or those struggling with epilepsy that has resisted treatment. Epilepsy.com is the home of the Epilepsy Therapy Project. Co-founded by Chairman Warren Lammert, it is a not-for-profit corporation dedicated to a singular focus: overcoming the funding gaps and roadblocks that slow the progress of new epilepsy therapies from the lab to the patient.