Featured Research

from universities, journals, and other organizations

Brain stimulation device demonstrates safety, seizure reduction

Date:
December 8, 2013
Source:
American Epilepsy Society (AES)
Summary:
The findings from a 2-year multicenter randomized double blinded controlled clinical study, and a 7 year long-term treatment study of the NeuroPace RNS System are now available. The RNS System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible levels of electrical stimulation to normalize brain activity before an individual experiences seizures.

Researchers present the findings from a 2-year multicenter randomized double blinded controlled clinical study and a 7 year long-term treatment study of the NeuroPace RNS System at the American Epilepsy Society's 67th Annual Meeting. The RNS System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible levels of electrical stimulation to normalize brain activity before an individual experiences seizures. NeuroPace received pre-market approval from the U.S. Food and Drug Administration in November.

Related Articles


The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study. The RNS System has demonstrated safety and effectiveness in patients who average three or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9 percent reduction in seizure frequency in patients treated with responsive stimulation compared to a 17.3 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. The difference is statistically significant (p=0.012). For those subjects who reached two years post-implant, 55% of the subjects experienced a 50% or greater reduction in seizures.

An evaluation of the 191 implanted patients from the pivotal study found that there was no difference between the active and sham stimulation groups in the rate of adverse events, including depression, memory impairment and anxiety. There were no serious unanticipated device related adverse events reported in any of the clinical trials. Although there can be no assurances that additional long-term data will not reveal new adverse information presently unknown to NeuroPace, two year data shows no increase or worsening of adverse events.

"The results of the pivotal study clearly demonstrate that the safety and efficacy of the RNS System is sustained over two years. Additional data about safety and efficacy beyond two years is being collected in a long-term follow-up study," said Martha Morrell, MD, NeuroPace Chief Medical Officer and Clinical Professor of Neurology at Stanford University.


Story Source:

The above story is based on materials provided by American Epilepsy Society (AES). Note: Materials may be edited for content and length.


Cite This Page:

American Epilepsy Society (AES). "Brain stimulation device demonstrates safety, seizure reduction." ScienceDaily. ScienceDaily, 8 December 2013. <www.sciencedaily.com/releases/2013/12/131208090333.htm>.
American Epilepsy Society (AES). (2013, December 8). Brain stimulation device demonstrates safety, seizure reduction. ScienceDaily. Retrieved March 26, 2015 from www.sciencedaily.com/releases/2013/12/131208090333.htm
American Epilepsy Society (AES). "Brain stimulation device demonstrates safety, seizure reduction." ScienceDaily. www.sciencedaily.com/releases/2013/12/131208090333.htm (accessed March 26, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Thursday, March 26, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

House Ready to Pass Medicare Doc Bill

House Ready to Pass Medicare Doc Bill

AP (Mar. 26, 2015) In rare bipartisan harmony, congressional leaders pushed a $214 billion bill permanently blocking physician Medicare cuts toward House passage Thursday, moving lawmakers closer to resolving a problem that has plagued them for years. (March 26) Video provided by AP
Powered by NewsLook.com
HIV Outbreak Prompts Public Health Emergency In Indiana

HIV Outbreak Prompts Public Health Emergency In Indiana

Newsy (Mar. 26, 2015) Indiana Gov. Mike Pence says he will bring additional state resources to help stop the epidemic. Video provided by Newsy
Powered by NewsLook.com
AAA: Distracted Driving a Serious Teen Problem

AAA: Distracted Driving a Serious Teen Problem

AP (Mar. 25, 2015) While distracted driving is not a new problem for teens, new research from the AAA Foundation for Traffic Safety says it&apos;s much more serious than previously thought. (March 25) Video provided by AP
Powered by NewsLook.com
Obama: Affordable Care Act 'saving Lives'

Obama: Affordable Care Act 'saving Lives'

AP (Mar. 25, 2015) Speaking at a White House event marking the fifth anniversary of the Affordable Care Act, President Barack Obama says the law is "saving lives that touch all of us." (March 25) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins