LOS ANGELES, July 5, 2011 /PRNewswire/ -- NeuroSigma, a Los Angeles-based neuromodulation company, today announced that a recent Phase I clinical trial revealed that external Trigeminal Nerve Stimulation (eTNS™) increased regional cerebral blood flow in brain regions associated with depression and mood regulation. eTNS™ was shown to be a potential therapy for depression, with significant reductions in depression severity during the 8-week adjunctive treatment period. These encouraging results have led to a Phase II double-blind trial with expected completion later this year.
eTNS™ and Depression
Trigeminal Nerve Stimulation (TNS) is a promising new therapy for the treatment of major depression without the typical side effects of antidepressants. TNS was invented by researchers at UCLA and is exclusively licensed to NeuroSigma.
In June of last year, UCLA investigators reported preliminary results from the first five patients of the open-label Phase I TNS feasibility trial, noting a 70% reduction in symptom severity over the 8-week acute phase of treatment, resulting in an 80% remission rate. (http://newsroom.ucla.edu/portal/ucla/non-invasive-therapy-significantly-169741.aspx).
Last month, at the New Clinical Drug Evaluation Unit (NDCEU) 51st Annual Meeting in Boca Raton, Florida, Ian Cook, M.D., the Joanne and George Miller Family Chair in Depression Research at the Semel Institute at UCLA, and a medical advisor to NeuroSigma, presented additional data from four new subjects enrolled in this Phase I trial, which included functional neuroimaging PET data. Cook noted that "with just brief exposure to eTNS™, significant increases in regional cerebral blood flow were detected in the anterior cingulate and the dorsomedial frontal cortical regions, which are brain regions implicated in mood disturbances – most notably the anterior cingulate gyrus, inferior frontal gyrus, medial and middle frontal gyri and the parietotemporal cortex." Cook added, "These findings of a potential mechanism of action support our original hypothesis that electrical stimulation of the trigeminal nerves, located in facial skin tissue, can provide a very safe and effective means to send signals to key structures deep in the brain, thus providing a high-bandwidth pathway to the brain without current penetrating directly through the skull." These four subjects realized a 44% reduction in their HDRS depression severity score during the 8-week treatment period.
"We would like to congratulate Drs. Cook, Lara Schrader, Daniel Silverman, Christopher DeGiorgio, and the rest of the UCLA team for these impressive PET findings," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "These results have identified a potential mechanism of action of TNS, should facilitate discussions with potential strategic partners and the investment community and have provided us with clues as to which indications to add to our TNS pipeline. In addition to depression, we have clinical trials underway for epilepsy and post-traumatic stress disorder (PTSD) and expect to initiate clinical trials for additional indications in the near future," added Ekchian.
"We wish to especially thank Dr. John Mazziotta, Chairman of the UCLA Department of Neurology and Director of the UCLA Brain Mapping Center, which is widely regarded as the singular facility for neuroimaging in the world, for his support in making this breakthrough possible," said Lodwrick M. Cook, Chairman of NeuroSigma.
UCLA investigators have commenced the twenty-subject, double-blind, Phase II clinical trial, with funding provided by NeuroSigma, to further assess the safety and efficacy of eTNS™ as a potential adjunctive therapy for the treatment of depression. The trial began in February with a target completion date in late 2011.
Over 18 million Americans suffer from major depression, which affects mood, sleep, memory, concentration and raises thoughts of suicide. It is the current leading cause of disability for 15-44 year olds. The World Health Organization projects that after heart disease, major depression will be the most significant cause for disability in the world by 2020.
Antidepressant drugs are the most common therapy for depression, however they can have major side effects, including obesity, sexual dysfunction, fatigue, drowsiness and nausea. Furthermore, prescribing antidepressants typically entails a trial and error selection process with only 30% of patients reaching remission with their first antidepressant trial. Many patients abandon treatment before effectiveness can be determined.
NeuroSigma is developing two embodiments of TNS: eTNS™ and sTNS™ (subcutaneous electrodes). Once approved by regulatory agencies, patients who respond well to eTNS™ can opt to switch to the implantable sTNS™ system.
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 (UCLA), 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
SOURCE NeuroSigma, Inc.