A first patient has been enrolled in a single-site trial to evaluate the potential of electrical stimulation, called Electroceutical Therapy, in reducing brain injury, Endonovo Therapeutics, the therapy’s developer, announced.
Electroceutical Therapy is a non-invasive and wearable electronic device that uses pulsed electromagnetic fields (PEMF) to stimulate the central nervous system. The device repurposes the natural signals produced by the central nervous system to alleviate or mitigate symptoms of brain injury.
“We believe our technology, whose proven mechanism of action is the suppression of inflammation, has the potential to change the treatment of central nervous system disorders where neuroinflammation propagates injury such as ischemic stroke, Alzheimer’s disease, and multiple sclerosis,” Alan Collier, chief executive officer for Endonovo, said in a press release.
The study is taking place at the University of New Mexico, and will test the effects of PEMF on easing symptoms of brain injury and on biomarkers of inflammation in the blood and cerebrospinal fluid in patients with brain injury.
It plans to enroll 48 people with brain injuries who have or are fitted with an external ventricular drain to remove excess cerebrospinal fluid, the release states. These patients were enrolled in a previous study of the device’s safety and are now moving to test its effectiveness.
The enrolled patient has severe traumatic brain injury.
Fluid samples will be collected at baseline and then every eight hours until the drain is removed. Biomarkers of inflammation and other measures, such as vital signs, blood flow, and tissue oxygenation, will be assessed.
“After completing two PEMF safety studies on volunteers and patients with brain injury currently submitted for publication, we have consented and studied our first severe traumatic brain injury patient for the PEMF study and collected brain fluid and serum samples for four days post-injury,” said Edwin Nemoto, PhD, from University of New Mexico Health Sciences Center, School of Medicine.
Endonovo is focused on the treatment of central nervous system disorders, inflammatory conditions, and cardiovascular diseases. The company’s SofPulse Electroceutical System is approved for managing post-operative pain, swelling, and soft tissue injuries in both the U.S. and the EU.
Multiple sclerosis, a neurodegenerative, inflammatory disease, is characterized by the degradation of the myelin sheath surrounding nerve cells, resulting in brain and spinal cord injury.