U.S. Army Funds NeuroSigma PTSD Phase 2 Trial

California-based life sciences company NeuroSigma announced that the U.S. Department of the Army through its U.S. Army Medical Research and Material Command has provided funding for a Phase II clinical trial to investigate use of external trigeminal nerve stimulation (eTNS) as treatment for post-traumatic stress disorder (PTSD).

The company’s Monarch eTNS System is a non-invasive treatment for neuropsychiatric and neurological disorders. A previous Phase I clinical trial of eTNS for the adjunctive treatment of PTSD showed significant improvements in the severity of PTSD symptoms after participants experienced eight weeks of nightly eTNS therapy.

As part of the agreement, NeuroSigma will provide eTNS Systems for the trial, which will be conducted at the University of California, Los Angeles (UCLA). The study will be led by Andrew Leuchter, professor of psychiatry and biobehavioral sciences at UCLA and a physician at the Greater Los Angeles Veterans Administration (GLAVA) Health Care System. The Phase II study will involve 74 participants to assess eTNS under double-blind conditions primarily for military combat veterans who still show symptoms of PTSD after undergoing GLAVA.

Post-traumatic stress disorder is an anxiety condition that is caused by exposure to traumatic events, such as threat of bodily harm in military combat, domestic violence, and natural disasters, among others. People who suffer from PTSD experience flashbacks, emotional numbness, nightmares, edginess, and tension among other symptoms. Approximately 7.8 percent of people in the U.S. will experience PTSD during the course of their lifetimes. Around 3.5 percent of adults in the U.S. from 18 to 54 years old —  approximately 5.2 million people — suffer from the disorder during the course of a given year.

Dr. Ian Cook, NeuroSigma's CMO and SVP, said, “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.” Dr. Cook, Professor of Psychiatry and Biobehavioral Sciences at the David Geffen School of Medicine at UCLA, joined NeuroSigma this June.