Welcome!

News Feed Item

Results of Pediatric Clinical Trial of External Trigeminal Nerve Stimulation for the Treatment of ADHD

To Be Presented May 20, 2013 At American Psychiatric Association Annual Meeting in San Francisco

LOS ANGELES, April 18, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced that the results of the first-ever pediatric clinical trial of external Trigeminal Nerve stimulation (eTNS™) for the treatment of attention-deficit hyperactivity disorder (ADHD) will be presented at the American Psychiatric Association annual meeting in San Francisco on May 20, 2013.  The clinical trial was conducted at the University of California, Los Angeles (UCLA) with funding provided by NeuroSigma.

This study, which began in November 2011, was a Phase I open-label trial of children ages 7 to 14 who had a DSM – IV diagnosis of ADHD.  Subjects received eTNS nightly as monotherapy for the 8-week study period.  ADHD symptom severity and cognitive performance were assessed at baseline, four weeks and eight weeks.  The a priori outcome metric was the investigator-completed ADHD rating scale (ADHD-RS scale). 

The results will be presented by James McGough, M.D., M.S., principal investigator for the study and Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior and David Geffen School of Medicine at UCLA, and director of clinical teaching programs in both Child and Adolescent Psychopharmacology and ADHD at UCLA.  Dr. McGough is a leading researcher in the field and has worked to understand ADHD's causes and develop new treatments for nearly two decades. 

"PET scan data that showed the immediate effects of eTNS on activity in centers in the brain associated with attention prompted our interest in exploring eTNS as a treatment for ADHD in children," said Dr. McGough.  "There is a pressing need for non-stimulant options to manage ADHD given parental and patient preferences to avoid medication use as well as the possible side effects of these drug therapies." 

"The results of this study are eagerly awaited by the treatment community, especially by pediatricians, child psychologists and child psychiatrists who not only see severe side effects from current drug therapies but also worry about the significant risks for diversion and abuse of these drugs," said Ian Cook, M.D., Director of the UCLA Depression Research & Clinic Program, where initial studies of eTNS began in psychiatric conditions. Dr. Cook is also one of the inventors of eTNS and a Senior Scientific Advisor to NeuroSigma.

Background - TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain.  The trigeminal nerve projects 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 very close to the surface of the skin in the forehead.  The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain.  PET imaging studies in humans confirm that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.

NeuroSigma is the exclusive worldwide licensee of UCLA's entire TNS intellectual property portfolio and continues to develop additional technologies and target additional indications.

CAUTION: In the United States, both eTNS™ and sTNS™ are investigational devices and are limited by Federal (or United States) law to investigational use.

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

About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical device company established to develop early stage technologies with the potential to transform medical practice and patients' lives.  Currently, NeuroSigma is focused on neuromodulation therapies and has amassed significant 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.

NeuroSigma's first TNS product, the Monarch™ eTNS™ System, is currently being marketed to patients in the European Union (EU), with a physician's prescription. In September 2012, NeuroSigma received CE Mark approval for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older in the EU. The Monarch was recently unveiled in London at the 10th European Congress on Epileptology. The Monarch™ eTNS™ System consists of a small stimulator that can be placed in a pocket or worn at the waist, and an electric patch that is placed on the forehead. The patch stimulates the trigeminal nerve through the surface of the skin, and is used primarily while the patient is asleep.

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™ and sTNS™ systems.  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.

NeuroSigma Contacts:

Dr. Leon Ekchian, President & CEO
Tel: +1-310-479-3100
Email: [email protected]
NeuroSigma, Inc.
Website: http://www.neurosigma.com

Mr. Mark Collinson, Partner
Tel: +1-310-954-1343
Email: [email protected]
CCG Investor Relations
Website: http://www.ccgir.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
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...
IoT is fundamentally transforming the auto industry, turning the vehicle into a hub for connected services, including safety, infotainment and usage-based insurance. Auto manufacturers – and businesses across all verticals – have built an entire ecosystem around the Connected Car, creating new customer touch points and revenue streams. In his session at @ThingsExpo, Macario Namie, Head of IoT Strategy at Cisco Jasper, will share real-world examples of how IoT transforms the car from a static p...
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will look at the protocols that communicate data and the emerging data analy...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
Creating replica copies to tolerate a certain number of failures is easy, but very expensive at cloud-scale. Conventional RAID has lower overhead, but it is limited in the number of failures it can tolerate. And the management is like herding cats (overseeing capacity, rebuilds, migrations, and degraded performance). Download Slide Deck: ▸ Here In his general session at 18th Cloud Expo, Scott Cleland, Senior Director of Product Marketing for the HGST Cloud Infrastructure Business Unit, discusse...
Whether they’re located in a public, private, or hybrid cloud environment, cloud technologies are constantly evolving. While the innovation is exciting, the end mission of delivering business value and rapidly producing incremental product features is paramount. In his session at @DevOpsSummit at 19th Cloud Expo, Kiran Chitturi, CTO Architect at Sungard AS, will discuss DevOps culture, its evolution of frameworks and technologies, and how it is achieving maturity. He will also cover various st...
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...