Navigation Links
Positive Results Reported for Phase II Randomized Double-Blind Clinical Trial for the Treatment of Drug-Resistant Epilepsy Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
Date:4/28/2011

LOS ANGELES, April 28, 2011 /PRNewswire/ -- This afternoon, at the Antiepileptic Drug Trials XI Conference in Miami, Florida, (http://www.epilepsy.com/etp/aedtrialxi) Dr. Christopher DeGiorgio, principal investigator and neurologist at UCLA, presented the results of a Phase II randomized double-blind clinical trial for the treatment of refractory epilepsy.  The 50-subject study was conducted at UCLA and the University of Southern California.  "I'm excited to see that our non-invasive and very safe approach to neuromodulation demonstrates efficacy under double-blind controlled conditions and compares favorably with pharmaceutical and surgically-invasive approaches.  We look forward to proceeding to the next phase of the regulatory approval process and clinical development for our epilepsy therapies," DeGiorgio said.

This study was a randomized double-blind, active-controlled clinical trial of external TNS (eTNS™) therapy in 50 people with drug resistant epilepsy.  All subjects in the study were aged between 12 – 70 with a history of intractable seizures and exposure to at least two antiepileptic drugs at adequate doses.

The study was funded by investigator-initiated grants from the Epilepsy Therapy Project, the Epilepsy Foundation, Boston Scientific and the Milken Family Foundation.  The TNS technology, including eTNS™ for the treatment of epilepsy, was originally invented and developed at UCLA.

NeuroSigma, Inc., a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice, is the exclusive worldwide licensee of UCLA's TNS intellectual property.  "We are extremely pleased to be working closely with Dr. DeGiorgio and his talented and dedicated team at UCLA, to help make his vision of a safe, non-invasive therapy for epilepsy a reality," said Dr. Leon Ekchian, President and CEO of NeuroSigma.  

Background - TNS

NeuroSigma is developing two embodiments of TNS: eTNS™ (TNS with external electrodes and an external pulse generator) and sTNS™ (subcutaneous electrodes and implantable pulse generator).

The eTNS™ system utilizes a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve, which are located very close to the surface of the skin above the forehead.  The trigeminal nerve is one of the largest in the body, offering a high-bandwidth pathway for signals to enter the brain.  In clinical studies, eTNS™ is well tolerated and the low-energy stimulus is confined to the soft tissues of the face without penetration into the brain – hence the term "USB Port to 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 and other disorders. PET imaging studies in humans confirms that eTNS™ activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.

Once approved by regulatory agencies, patients who respond well to eTNS™ can opt to switch to the implantable sTNS™ system.  NeuroSigma is developing its own proprietary eTNS™ system but contemplates partnering for sTNS™ with other medical device companies, which already have commercially available implantable neurostimulation systems.

Results

The investigators reported that patients receiving active eTNS™ treatment experienced a significant improvement in seizure reduction, while those randomized to receive the control condition ("sham" or "placebo") did not.  "We showed that eTNS™ works well, under stringent clinical-trial conditions, with nearly 40% showing a clinically-meaningful response after 18 weeks of daily stimulation – there were 9 responders in the active group in contrast to 3 in the control group, where a responder experiences a greater than 50% reduction in seizures," noted Dr. DeGiorgio. In addition to reducing seizures, eTNS™ also improved mood.  These results confirm and extend the findings of DeGiorgio's positive feasibility trial in epilepsy, reported in 2009 in the prestigious journal Neurology.

CAUTION: Both eTNS™ and sTNS™ systems are investigational devices and at this time are limited by United States law for investigational use only.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice.  Currently we have a specific focus on neuromodulation.  NeuroSigma employs two therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS).  NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles, including potential therapies for epilepsy, depression and post-traumatic stress disorder (PTSD) via TNS and for PTSD, obesity and cachexia via DBS.  For more information about NeuroSigma, visit our website at http://www.neurosigma.com

NeuroSigma Contacts:

Dr. Leon Ekchian, President & CEO
Tel: 310-479-3100
Email: lekchian@neurosigma.com
NeuroSigma, Inc.
Website: http://www.neurosigma.com

Mr. Mark Collinson, Partner
Tel: +1-310-954-1343
Email: mark.collinson@ccgir.com
CCG Investor Relations
Website: http://www.ccgir.com


'/>"/>
SOURCE NeuroSigma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Reportlinker Adds Advanced Lung Cancer with EGFR Mutation Positive Adenocarcinoma
2. Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
3. Amgen and UCB Announce Positive Phase 2 Results of AMG 785/CDP7851 in Patients With Postmenopausal Osteoporosis (PMO)
4. Jennerex and Green Cross Announce Publication of Positive Clinical Data of JX-594 in Combination With Sorafenib in Advanced Liver Cancer
5. Merrimack Pharmaceuticals Announces that Recruitment is Open in a Phase 1 Combination Study of MM-111 with Multiple Treatment Regimens in HER2 Positive Patients
6. Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Study Results
7. Jennerex and Transgene Announce the Presentation of Positive Clinical Data of JX-594 in Patients With Liver Tumors
8. Publication in SLEEP Journal Demonstrates Positive Results of Large Multi-Center Clinical Trial for Provent® Sleep Apnea Therapy
9. Analysis of Data Across Multiple Drug Eluting Stent Trials Reinforces Positive Clinical Performance of XIENCE V®
10. Positive Phase 2 Results Reported with Boehringer Ingelheims Investigational HCV Protease Inhibitor in Both Previously Treated and Untreated Patients
11. Intercept Pharmaceuticals Announces Positive Phase II Results for Obeticholic Acid (INT-747) as Monotherapy in Primary Biliary Cirrhosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... June 23, 2016 Bracket , a leading ... next generation clinical outcomes platform, Bracket eCOA (SM) 6.0, ... June 26 – 30, 2016 in Philadelphia ... Clinical Outcome Assessment product of its kind to fully integrate ... Bracket eCOA 6.0 is a flexible platform for electronic ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/26/2016)... ... 27, 2016 , ... Quality metrics are proliferating in cancer care, and are ... the eye of the beholder, according to experts who offered insights and commentary in ... Managed Care. For the full issue, click here . , For the American ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
Breaking Medicine News(10 mins):