Major depression is a severe form of depression that significantly impacts a person’s ability to lead a healthy and productive life. It can affect people of all races, incomes, and background, and is the leading cause of disability in industrialized countries, affecting roughly 1 in 6 people at some point in their lives. Typical symptoms of major depression include feelings of sadness and joylessness, but may also include physical symptoms such as sleep disturbances, low energy, changes in appetite, and fatigue. Problems with concentration, motivation, and decision-making are commonplace as well. Treatments for depression include counseling, cognitive behavioral therapy, medications, transcranial magnetic stimulation, and electroconvulsive therapy (ECT). While these treatments can be effective, they often carry significant side effects and costs, and many people remain depressed despite treatment.
Trigeminal Nerve Stimulation (TNS) is a new neuromodulation treatment being developed by NeuroSigma as a treatment for major depression. Trigeminal nerve stimulation for depression has been studied at UCLA for several years, with positive research findings published in 2011 and 2013. This study of 11 subjects demonstrated positive results and found that after 8 weeks of nightly use, subjects with treatment-resistant depression were able to reduce their symptom severity by an average of 52%. These findings are extremely encouraging in this refractory population, and a Phase II double-blind trial is currently in progress.
Based on these results, NeuroSigma’s Monarch eTNS system has been approved for clinical use in the European Union and Canada. For more information on the Monarch, please visit our specialty site www.monarch-etns.com.
CAUTION: We have not received approval from the FDA to market our eTNS™ system or proposed sTNS™ system in the United States. Our eTNS™ system and proposed sTNS™ system are classified as investigational devices and are limited by Federal (or United States) law to investigational use only.