NeuroSigma has announced that the US Department of the Army, through the US Army Medical Research and Material Command, has funded a phase II clinical trial at the University of California, Los Angeles (UCLA) aimed at examining 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. The phase II clinical trial is expected to enrol 74 subjects to evaluate eTNS as adjunctive therapy under double-blind conditions for military combat veterans who remain symptomatic despite trials of conventional treatments through the GLAVA PTSD program. An earlier phase I 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.
“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 on not only on their lives, but also on their families and their communities. Leuchter and his team are to be congratulated for securing competitive federal funding for this rigorous double-blind clinical trial,” says Ian Cook, NeuroSigma’s chief medical officer and senior vice president. “The phase I clinical trial found improvement in PTSD symptom severity and also in measures of depression and quality of life. This phase II 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.”
In August 2012, NeuroSigma received CE mark approval to market NeuroSigma’s first trigeminal nerve stimulation product (Monarch eTNS system) in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine years and older. In addition, the Monarch system also received a class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of drug-resistant epilepsy (DRE) and MDD for adults and children nine years and older. In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for the adjunctive treatment of DRE in adults and children nine years and older. NeuroSigma is currently offering the system to patients in these jurisdictions with a physician’s prescription.