LOS ANGELES, Nov. 19, 2014 /PRNewswire/ -- NeuroSigma®, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive external trigeminal nerve stimulation (eTNS) technology for the treatment of neurological and neuropsychiatric disorders, applauds the accomplishments of an independent team of Brazilian researchers led by Pedro Shiozawa, M.D., on their positive top-line findings from a Phase II clinical trial of eTNS as adjunctive treatment for major depressive disorder (MDD). The trial was conducted at the Santa Casa de Sao Paulo School of Medicine in Sao Paulo, Brazil.
In this double-blind, randomized controlled trial, subjects with MDD received either active or sham therapy utilizing stimulation parameters previously used in NeuroSigma–funded clinical trials at the University of California, Los Angeles (UCLA). Treatment consisted of daily sessions of under an hour for two weeks as an adjunct to pharmacotherapy. The primary endpoint for the trial was the change in depressive symptoms on the Hamilton Depression Rating Scale (HDRS) among subjects receiving active versus those receiving sham therapy.
Forty adults with MDD were enrolled in the trial and randomized evenly between the active and sham arms. Thirty-five subjects completed the two-week treatment and medications remained constant throughout.
Subjects receiving active therapy demonstrated significantly greater improvements in symptom severity on the HDRS as compared to subjects receiving sham therapy after two weeks (64.5% decrease versus 32.6%, p=0.012).
"I am excited to have found a significant difference between the active and sham therapy groups in terms of symptom improvement," said Dr. Pedro Shiozawa, Professor of Psychiatry at the Santa Casa de Sao Paulo School of Medicine and Principal Investigator of the study. "The treatment was very well tolerated, without any serious side effects reported."
"We congratulate Dr. Pedro Shiozawa and his team for conducting this important clinical trial of eTNS in depression which builds on their successful Phase I open label trial reported earlier this year in the journal Epilepsy and Behavior. These clinical trials are complementary to those conducted at UCLA during the past several years in the treatment of depression with eTNS. We are delighted by the growing international interest in eTNS by leading researchers," said Ian Cook, M.D., Chief Medical Officer at NeuroSigma.
NeuroSigma's Monarch eTNS system is currently approved in the European Union for the adjunctive treatment of major depressive disorder and in Canada for treatment of major depressive disorder, in each case for adults and children nine years and older. In the United States, the Monarch eTNS system is an investigational device and is limited by Federal law to investigational use.
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, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (ADHD), traumatic brain injury (TBI), 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, the eTNS and sTNS systems are investigational devices and are 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 external TNS (eTNS) in drug-resistant epilepsy. Completion of that Phase III trial is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.
eTNS, sTNS, 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, PTSD, ADHD, and TBI. 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.