The SUDEP Institute Challenge: Predictive Biomarkers of Epilepsy Seizures
to propose a predictive biomarker or panel of biomarkers to identify people at risk for SUDEP. The biomarker(s) must serve as an endpoint or surrogate endpoint that will drive human SUDEP interventions. For example, the biomarker(s) may identify a high risk patient group that could be used to test existing candidate interventions such as seizure detection devices in a clinical trial.
Identifying biomarkers to predict SUDEP represents a major unmet medical need. Although there are several postulated causes of SUDEP, who is at risk of mortality from epilepsy and how to prevent it remains a mystery. Emerging research shows that SUDEP can be caused by physiological changes after seizures that depress brain activity and can impair respiratory and cardiac function. SUDEP usually occurs within an hour of one or more convulsive seizures.
There are few targeted interventions that reliably predict and prevent SUDEP in people with epilepsy. Therefore, the Epilepsy Foundation SUDEP Institute desires the identification of clinically relevant, specific and sensitive biomarkers of SUDEP to facilitate the development of a therapeutic intervention for people at high risk. Biomarkers may be genetic, structural, metabolic, physiological, etc. An ideal biomarker or biomarker panel is easily and safely measured, cost-efficient to detect, modifiable with intervention, and consistently associated with SUDEP and will drive human SUDEP interventions. The Epilepsy Foundation SUDEP Institute recognizes that the severity and frequency of seizures is the leading risk factor for SUDEP, therefore a biomarker or biomarker panel that can be predictive of seizures (particularly convulsive seizures) will also be considered.
Submissions to this Challenge must be received by 11:59 PM (US Eastern Time) on May 24, 2016. Late submissions will not be considered.
This is a Theoretical Challenge that requires only a written proposal to be submitted. The Challenge award will be contingent upon theoretical evaluation of the proposal by the Seeker. The Epilepsy Foundation SUDEP Institute intends to make up to 10 awards from a total award pool of up to $150,000. However, the Seeker may (i) not award any solution if none of the submitted proposals meets all Solution Requirements or (ii) award only the solution of the highest overall quality with $15,000. The awarded solution(s) will be advanced to produce proof of concept data in a subsequent Reduction to Practice Challenge which will award $1,000,000. This second Challenge may be public or by invitation only.
In rare cases, a lesion, usually identified by MRI and confirmed by biopsy, and in some cases by special autoantibodies, takes the form of a chronic focal encephalitis.
In 1958, Rasmussen described three children in whom the clinical problem consisted of intractable focal epilepsy in association with a progressive hemiparesis.
The cerebral cortex disclosed a mild meningeal infiltration of inflammatory cells and an encephalitic process marked by neuronal destruction, gliosis, neuronophagia, some degree of tissue necrosis, and perivascular cuffing. Many additional cases were soon uncovered and Rasmussen was able to summarize the natural history of 48 personally observed patients (see the often cited monograph by Andermann).
* According to Annals of Internal Medicine, this item could be outdated. See:
“Published data do not suggest an adverse effect of statins on cognition;
however, the strength of available evidence is limited, particularly with regard to high-dose statins.” http://annals.org/article.aspx?articleid=1770674
Trigeminal Nerve Stimulation an Option for ADHD? May 20, 2013 http://www.medscape.com/viewarticle/804440
Currently, the system has no approvals in the United States from the US Food and Drug Administration (FDA).
Leon Ekchian, president and CEO of NeuroSigma, Inc, said the company plans first to apply for the epilepsy indication in the United States, with depression next and ADHD indications probably further down the road.
An external trigeminal nerve stimulation (eTNS) system (Monarch, NeuroSigma, Inc) has received European Union (EU) CE Certification for the adjunctive treatment of epilepsy and major depressive disorder for adults and children aged 9 years and older.
The device has been evaluated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California. It consists of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily and are worn primarily during sleep.
frequent or prolonged seizures can eventually cause problems with memory and thinking.
seizures “can actually change the way language centers in the brain develop.”
low-carbohydrate diets, including the high-fat ketogenic diet
Then there are new implanted devices that send electrical signals to the vagus nerve
to provide parents and other caregivers with an emergency kit that lets them administer a fast-acting drug to stop a seizure.
“Epilepsy surgery is underutilized in this country,”
For about 30 percent of children with epilepsy, none of the existing treatments is adequate.
transplanting a type of cell that reduces excessive electrical activity in the brain. “Stem Cell therapy may be one way that we can very specifically target the region of the brain that is overexcited and quiet that area of the brain.”
Another experimental approach involves devices that monitor the brain for abnormal activity.
Some are able to predict when the brain activity is headed toward a seizure, Fureman says, “and actually deliver stimulation that shuts down that seizure activity.”