Potential Mechanism Of Action Identified For The Treatment Of Major Depression With Trigeminal Nerve Stimulation (TNS) The USB Port To The Brain&trade

Potential Mechanism Of Action Identified For The Treatment Of Major Depression With Trigeminal Nerve Stimulation (TNS) The USB Port To The Brain&mechanical employment

NeuroSigma, a Los Angeles-based neuromodulation visitor, announced that a recent Phase I clinical case revealed that external Trigeminal Nerve Stimulation (eTNS&exchange;) increased regional cerebral blood flow in brain regions associated with depression and mood regulation. eTNS&commerce; was shown to be a possible therapy for depression, with significant reductions in dolefulness severity during the 8-week adjunctive usage period. These encouraging results have led to a Phase II double-disguise trial with expected completion later this year.

eTNS&purchase and sale; and Depression

Trigeminal Nerve Stimulation (TNS) is a promising new therapy for the treatment of greater depression without the typical side furniture of antidepressants. TNS was invented ~ the agency of researchers at UCLA and is exclusively licensed to NeuroSigma.

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 sanatory advisor to NeuroSigma, presented additional data from four new subjects enrolled in this Phase I examination, which included functional neuroimaging PET premises. Cook noted that "with just breviary exposure to eTNS™, significant increases in regional cerebral kindred flow were detected in the foregoing cingulate and the dorsomedial frontal cortical regions, which are brain regions implicated in mood disturbances most notably the anterior cingulate gyrus, poor frontal gyrus, medial and middle frontlet gyri and the parietotemporal cortex." Cook added, "These findings of a potential mechanism of performing support our original hypothesis that electrical stimulation of the trigeminal nerves, located in facial derm tissue, can provide a very undamaged and effective means to send signals to lock opener structures deep in the brain, to this degree providing a high-bandwidth pathway to the brain lacking current penetrating directly through the cranium." These four subjects realized a 44% lessening in their HDRS depression severity score during the 8-week treatment cycle.

"We would like to congratulate Drs. Cook, Lara Schrader, Daniel Silverman, Christopher DeGiorgio, and the rest of the UCLA team because of these impressive PET findings," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "These results wish identified a potential mechanism of brush of TNS, should facilitate discussions through potential strategic partners and the investing. community and have provided us with clues as to which indications to reckon up to our TNS pipeline. In addition to depression, we have clinical trials underway in favor of epilepsy and post-traumatic stress complaint (PTSD) and expect to initiate clinical trials because of additional indications in the near futurity," added Ekchian.

"We wish to especially return ~s to Dr. John Mazziotta, Chairman of the UCLA Department of Neurology and Director of the UCLA Brain Mapping Center, that is widely regarded as the unparalleled facility for neuroimaging in the terraqueous globe, for his support in making this breakthrough practicable," said Lodwrick M. Cook, Chairman of NeuroSigma.

UCLA investigators desire commenced the twenty-subject, double-involved, Phase II clinical trial, with funding if by NeuroSigma, to further assess the security and efficacy of eTNS™ taken in the character of a potential adjunctive therapy for the method of treating of depression. The trial began in February by a target completion date in not long ago 2011.

Depression Background

Over 18 very great number Americans suffer from major depression, what one. affects mood, sleep, memory, concentration and raises thoughts of suicide. It is the current leading reason of disability for 15-44 year olds. The World Health Organization projects that succeeding heart disease, major depression will be the most significant cause for inability in the world by 2020.

Antidepressant drugs are the in the greatest degree common therapy for depression, however they be possible to have major side effects, including corpulence, sexual dysfunction, fatigue, drowsiness and inclination to vomit. Furthermore, prescribing antidepressants typically entails a testing and error selection process with merely 30% of patients reaching remission through their first antidepressant trial. Many patients abandon treatment before effectiveness can be determined.

NeuroSigma is developing pair embodiments of TNS: eTNS™ and sTNS&traffic; (subcutaneous electrodes). Once approved by regulatory agencies, patients who be agreeable to well to eTNS™ can opt to switch to the implantable sTNS&commerce; system.

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