The US Army has provided funding for NeuroSigma’s Phase II clinical trial designed to evaluate the use of external trigeminal nerve stimulation (eTNS) system to treat post-traumatic stress disorder (PTSD).
PTSD occurs after exposure to traumatic events, such as the threat of physical harm in military combat, domestic violence, car accidents, terrorist attacks and natural disasters.
Around 74 subjects are expected to be enrolled in the trial, which is being carried out at the University of California, Los Angeles (UCLA).
UCLA professor of Psychiatry and Biobehavioral Sciences and a physician at the Greater Los Angeles Veterans Administration (GLAVA) Health Care System Dr Andrew Leuchter will lead the Phase II trial as principal investigator.
The trial will assess 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 programme.
According to a NeuroSigma-funded Phase I clinical trial, which is also conducted at UCLA, significant improvements have been observed in the severity of PTSD symptoms with eight weeks of nightly eTNS therapy.
NeuroSigma chief medical officer and senior vice-president Dr Ian Cook said: “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.
“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.”
NeuroSigma is focused on commercialising its non-invasive Monarch eTNS System for the treatment of neurological and neuropsychiatric disorders.
The company secured CE Mark approval in August 2012 to market its first trigeminal nerve stimulation (TNS) product, the Monarch eTNS System, in the EU, to treat adults and children above nine years with epilepsy and major depressive disorder (MDD).
The Monarch eTNS System includes a cell-phone-sized pulse generator and a single-use patch that is applied to the forehead.
The device works by transmitting signals through lead wires to the patch to stimulate the trigeminal nerve in the skin of the forehead.