NeuroSigma has announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the US Veterans Affairs for a clinical trial to evaluate the benefits of non-invasive, external trigeminal nerve stimulation (eTNS) for patients with traumatic brain injury.
Jean-Philippe Langevin, an expert in neurotrauma and a neurosurgeon at the Veterans Affairs Greater Los Angeles (VAGLA) medical centre, will lead the study as principal investigator. The project will enrol US military veterans with traumatic brain injury in an eight-week treatment protocol, and will examine change in cognitive function and regional brain activity as people receive nightly eTNS treatment at home.
Traumatic brain injury is a condition that arises after mechanical injury to the brain. According to the Centers for Disease Control and Prevention, an estimated 5.3 million Americans currently live with traumatic brain injury-related disability, with an annual total cost in 2010 estimated at US$76.5 billion, including US$11.5 billion in direct medical costs and US$64.8 billion in indirect costs including lost wages, lost productivity, and nonmedical expenditures. The Department of Defense has reported approximately 200,000 cases of traumatic brain injury in troops between 2000 and June 2010. While many individuals recover fully, approximately 15 to 34% of individuals with mild or moderate traumatic brain injury have persistent symptoms that may interfere with their return to work or school, including difficulties with memory, decision making, attention, movement, and emotional functioning. These issues not only impact the injured individuals, but also can have lasting effects on their families and communities.
“We are excited to be working with Dr Langevin and his colleagues on this important project. There is an acute need for more non-invasive traumatic brain injury treatment options, not only for our veterans returning from overseas combat operations but also for the millions of Americans involved in motor vehicle accidents, falls, and sports-related concussions,” says Lodwrick M Cook, chairman of NeuroSigma.
“Neuroimaging data from PET scans suggest that eTNS can influence the activity of certain brain areas associated with the cognitive functions that are disrupted in traumatic brain injury. This effect may be able to help these individuals overcome their impairments and the purpose of this study is to gather evidence related to this hypothesis,” adds Ian A Cook, NeuroSigma’s chief medical officer and senior vice president.
“We owe it to our veterans to evaluate whether eTNS can help with traumatic brain injury and are delighted to support this important phase I clinical trial by supplying Monarch eTNS systems. We are excited to be adding traumatic brain injury to our pipeline of therapies under development,” says Leon Ekchian, NeuroSigma’s president and chief executive officer.