Welcome!

News Feed Item

U.S. Army Funds Phase II Clinical Trial at UCLA for the Treatment of PTSD with the NeuroSigma eTNS System

LOS ANGELES, Aug. 25, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ System for the treatment of neurological and neuropsychiatric disorders, today announced that the U.S. Department of the Army, through the U.S. Army Medical Research and Material Command, has funded a Phase II clinical trial at the University of California, Los Angeles (UCLA), that will examine the use of external trigeminal nerve stimulation (eTNS) as treatment for post-traumatic stress disorder (PTSD).

Andrew Leuchter, M.D., Professor of Psychiatry and Biobehavioral Sciences at UCLA and a physician at the Greater Los Angeles Veterans Administration (GLAVA) Health Care System, will lead the study as Principal Investigator.  The Phase II clinical trial will enroll 74 subjects to evaluate eTNS as adjunctive therapy under double-blind conditions for military combat veterans who are still symptomatic despite trials of conventional treatments through the GLAVA PTSD program.  An earlier Phase I clinical trial of eTNS for the adjunctive treatment of PTSD, conducted at UCLA and funded by NeuroSigma, found significant improvements in the severity of PTSD symptoms with eight weeks of nightly eTNS therapy.  NeuroSigma will supply eTNS Systems to support the trial. Dr. Leuchter does not have any affiliation with NeuroSigma.

PTSD is an anxiety condition that arises after exposure to a traumatic event, such as the threat of physical harm in military combat, but also domestic violence, car accidents, terrorist attacks and natural disasters such as earthquakes or hurricanes. Symptoms include flashbacks, nightmares, emotional numbing, avoiding situations that are reminders of the experience, being easily startled, and feeling tense or "on edge."  These symptoms may make it difficult to go about daily life, perform well in school or at work, or to have social relationships.  According to the Nebraska Department of Veterans' Affairs, an estimated 7.8% of Americans will experience PTSD at some point in their lives and about 3.6% of U.S. adults aged 18 to 54 (5.2 million people) have PTSD during the course of a given year. 

"We are delighted that the U.S. Army will support Dr. Leuchter and his colleagues in this important study in PTSD.  Many of our brave veterans have returned from combat with PTSD, and need more effective treatment options," noted Leon Ekchian, Ph.D., NeuroSigma's President and CEO.

"Despite the best pharmaceutical and psychological treatments for PTSD, many patients still experience symptoms after months and months of trying to get well, with impact not only on their lives, but also on their families and their communities.  Dr. Leuchter and his team are to be congratulated for securing competitive federal funding for this rigorous double-blind clinical trial," said Ian Cook, M.D, NeuroSigma's Chief Medical Officer and Senior Vice President. "The Phase I clinical trial found improvement in PTSD symptom severity and also in measures of depression and quality of life.  This Phase II trial will evaluate the effects of eTNS on PTSD in a larger group and specifically in combat veterans. We owe it to our veterans to develop new treatments to address their unmet medical needs.  A safe, non-invasive neuromodulation treatment may be able to help give them back their lives where other treatments have fallen short." 

Background – The Monarch eTNS System from NeuroSigma

In August 2012, NeuroSigma received CE Mark approval to market NeuroSigma's first trigeminal nerve stimulation (TNS) product, the Monarch™ eTNS™ System, in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine years and older. In addition, the Monarch™ eTNS™ System also received a Class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of drug-resistant epilepsy (DRE) and MDD for adults and children nine years and older.  In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for the adjunctive treatment of DRE in adults and children nine years and older. NeuroSigma is currently offering the Monarch™ eTNS™ System to patients in these jurisdictions with a physician's prescription.

The Monarch™ eTNS™ System is composed of a cell-phone sized pulse generator and a single-use patch that is applied to the forehead.  Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there.  Patients may conveniently self-administer the Monarch™ eTNS™ System at home and typically use the device while sleeping.

Background – TNS

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD, and other disorders. 

Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located near the surface of the forehead.  Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.

CAUTION: In the United States, eTNS™ is an investigational device and is limited by Federal law to investigational use.  The U.S. Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of eTNS in drug-resistant epilepsy. Completion of that Phase III study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.

eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives.  NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). For more information about NeuroSigma, please visit www.neurosigma.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS™ system.  These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.

Website:
http://www.neurosigma.com
http://www.Monarch-eTNS.com

SOURCE NeuroSigma, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
New Relic, Inc. has announced a set of new features across the New Relic Software Analytics Cloud that offer IT operations teams increased visibility, and the ability to diagnose and resolve performance problems quickly. The new features further IT operations teams’ ability to leverage data and analytics, as well as drive collaboration and a common, shared understanding between teams. Software teams are under pressure to resolve performance issues quickly and improve availability, as the comple...
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, will draw upon their own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He will also discuss the implementation of microservices in data and applicat...
Join IBM June 8 at 18th Cloud Expo at the Javits Center in New York City, NY, and learn how to innovate like a startup and scale for the enterprise. You need to deliver quality applications faster and cheaper, attract and retain customers with an engaging experience across devices, and seamlessly integrate your enterprise systems. And you can't take 12 months to do it.
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
As you respond to increasing requests for new analytics, you need fast and flexible technology in your arsenal so that you can deploy the right workload to the right platform for the need at hand. Do you need self-service and fast time to value? Do you have data and application control and privacy needs, along with strict SLAs to meet? IBM dashDB™ is data warehouse technology powered by in-memory computing and in-database analytics that are designed for fast results, scalability and more.
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.