February 18, 2013
Implantable Device Reduces Seizures In Epileptic Patients
Lawrence LeBlond for redOrbit.com - Your Universe Online
A medical device company recently received funding from a branch of the National Institutes of Health (NIH) to conduct a new two-Phase clinical trial for an internally-implanted electronic device that may help treat epilepsy.
NeuroSigma Inc., the company behind the device, is basing the new trial on evidence of another similar device, an electronic patch that has been shown to reduce symptoms of depression by up to 50 percent. That device, the non-invasive external trigeminal nerve stimulation (eTNS) system, was implemented in a randomized controlled trial reported online in the January 30, 2013 issue of the journal Neurology.
The eTNS system, which is worn on the forehead while patients sleep, is connected via wires to a battery pack and sends stimulating signals to nerves under the skin that feed deep inside the brain to key regions associated with mood. The trial showed to cause a 50 percent improvement in symptoms of people suffering from depression.
“The patch is placed on the skin above the eyebrows and stimulates the nerve under the skin. It generates pulses of very low current — it feels like a mild tingling,” device inventor Dr. Christopher DeGiorgio, a professor of neurology at UCLA, told The Telegraph.
A second small study also published in the journal Neurology, has found that the patch also helps patients suffering from epilepsy, apparently reducing the number of seizures they have by as much as 40 percent.
That finding has led NeuroSigma to push for further funding for another clinical trial with a new device, an implantable subcutaneous trigeminal nerve stimulation (sTNS) system, to study its efficacy on epileptic patients.
The company announced earlier this month that it won funding from the National Institute of Neurological Disorders and Stroke (NINDS) in the amount of $600,000 for Phase I, and another $3 million for Phase II, subject to the satisfactory results of the initial phase.
The researchers presented the results of their small epileptic seizure-reducing eTNS system trial at the Royal Society of Medicine in London on Sunday.
DeGiorgio said the patch “stabilizes the activity in areas of the brain of people who suffer from epilepsy.”
With new funding in place, NeuroSigma hopes to continue the success seen with the eTNS system, which has shown some effectiveness of reducing symptoms in patients suffering from both depression and epilepsy.
The company is also looking for regulatory approval in order to market the systems. First, patients would be placed on the eTNS system, and those who respond well, could become likely candidates for the sTNS system, which would be a more permanent treatment option for fighting the symptoms of depression and epilepsy.
“We are extremely pleased by the recognition and continuing support of the NINDS, knowing that its highly regarded peer review process includes a rigorous review by leading medical experts,” said Dr. DeGiorgio.
“This is our third NIH grant. As a small business we applaud the support of the NIH in transitioning promising technologies from the laboratory to the clinic,” said Leon Ekchian, PhD, President & CEO of NeuroSigma.