NeuroSigma Inc., a California-based life sciences company focused on commercialization of its non-invasive Monarch eTNS System for the treatment of neurological and neuropsychiatric disorders, announced that the U.S. Department of the Army, through the U.S. Army Medical Research and Material Command, has funded a Phase 2 clinical trial at the University of California, Los Angeles (UCLA), that will examine the use of external trigeminal nerve stimulation (eTNS) as treatment for post-traumatic stress disorder (PTSD).
Andrew Leuchter, professor of psychiatry and biobehavioral sciences at UCLA and a physician at the Greater Los Angeles Veterans Administration (GLAVA) Health Care System, will lead the study as Principal Investigator. The Phase 2 clinical trial will enroll 74 subjects to evaluate eTNS as adjunctive therapy under double-blind conditions for military combat veterans who are still symptomatic despite trials of conventional treatments through the GLAVA PTSD program. An earlier Phase 1 clinical trial of eTNS for the adjunctive treatment of PTSD, conducted at UCLA and funded by NeuroSigma, found significant improvements in the severity of PTSD symptoms with eight weeks of nightly eTNS therapy. NeuroSigma will supply eTNS Systems to support the trial. Leuchter does not have any affiliation with NeuroSigma.
PTSD is an anxiety condition that arises after exposure to a traumatic event, such as the threat of physical harm in military combat, but also domestic violence, car accidents, terrorist attacks and natural disasters such as earthquakes or hurricanes. Symptoms include flashbacks, nightmares, emotional numbing, avoiding situations that are reminders of the experience, being easily startled, and feeling tense or “on edge.” These symptoms may make it difficult to go about daily life, perform well in school or at work, or to have social relationships. According to the Nebraska Department of Veterans’ Affairs, an estimated 7.8% of Americans will experience PTSD at some point in their lives and about 3.6% of U.S. adults aged 18 to 54 (5.2 million people) have PTSD during the course of a given year.
“We are delighted that the U.S. Army will support Dr. Leuchter and his colleagues in this important study in PTSD. Many of our brave veterans have returned from combat with PTSD, and need more effective treatment options,” noted Leon Ekchian, NeuroSigma’s president and CEO.
“Despite the best pharmaceutical and psychological treatments for PTSD, many patients still experience symptoms after months and months of trying to get well, with impact not only on their lives, but also on their families and their communities. Dr. Leuchter and his team are to be congratulated for securing competitive federal funding for this rigorous double-blind clinical trial,” said Ian Cook, NeuroSigma’s chief medical officer and senior vice president. “The Phase 1 clinical trial found improvement in PTSD symptom severity and also in measures of depression and quality of life. This Phase 2 trial will evaluate the effects of eTNS on PTSD in a larger group and specifically in combat veterans. We owe it to our veterans to develop new treatments to address their unmet medical needs. A safe, non-invasive neuromodulation treatment may be able to help give them back their lives where other treatments have fallen short.”
Date: August 25, 2014