Epilepsy

Epilepsy is a neurologic disorder characterized by recurrent seizures that affects roughly 50 million people worldwide. The primary treatment for epilepsy is medication, but these medications commonly have severe side effects, and approximately 1/3 of patients with epilepsy continue to have seizures despite taking multiple medications. This serious condition is known as drug-resistant epilepsy (DRE), and is associated with unemployment, injuries, and a significantly increased risk of death. There is a clear need for new therapies that address this large, underserved population.

Epilepsy

After 18 weeks of eTNS, 40.5% of patients with epilepsy were able to reduce their number of seizures by 50% or more. Additionally, patients receiving eTNS reported significant improvements in mood as measured by the Beck Depression Inventory (BDI).
DeGiorgio et al, Neurology 2013.

Two separate clinical trials evaluating eTNS as a treatment for epilepsy have demonstrated positive results. Results from these trials were published in the journal Neurology in 2009 and 2013. The first trial was an open label study in 12 subjects with severe epilepsy. Subjects used eTNS nightly for 12 weeks, and were able to reduce their seizure frequency by an average of 66%. In 2013, results from a double-blind trial conducted at UCLA and USC in 42 subjects demonstrated that after 18 weeks of eTNS, 40% of subjects in the treatment group were able to decrease their seizure activity by 50% or more. Importantly, patients in the treatment group also demonstrated significant improvements in mood that were independent of the anti-seizure effect.

NeuroSigma's lead product, the Monarch™ eTNS™ system is now approved for the treatment of epilepsy in the European Union, Canada and Australia, and for the treatment of depression the European Union and Canada. For more information on the Monarch, please visit our specialty site here www.monarch-etns.com.

NeuroSigma is also planning a large, multi-center, double-blind randomized controlled trial of eTNS as a treatment for epilepsy. For more information about eTNS and ongoing clinical trials, please fill-out our contact form, and a NeuroSigma representative will get back to you shortly.

CAUTION: We have not received approval from the FDA to market our eTNS™ system or proposed sTNS™ system in the United States. Our eTNS™ system and proposed sTNS™ system are classified as investigational devices and are limited by Federal (or United States) law to investigational use only.

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