ONWARD has announced that the first patient has been enrolled in a pivotal trial evaluating its ARC Therapy, according to a company press release. The trial, named Up-LIFT, will evaluate the safety and effectiveness of ARC Therapy in restoring hand and arm function in people with spinal cord injury (SCI).
According to ONWARD, Up-LIFT is the first large-scale pivotal trial of non-invasive spinal cord stimulation technology. The first patient was enrolled at the Shepherd Center in Atlanta, USA. ONWARD further states it plans to enroll 65 subjects at up to 15 sites in the USA, Canada, UK, and Europe.
“For individuals with impaired arm and hand function due to spinal cord injury, improved hand function directly translates into meaningful gains in terms of quality of life – being able to eat, dress or perform other day-to-day activities,” said Edelle Field-Fote, co-PI of the Up-LIFT trial and director of SCI research and professor of rehabilitation medicine at Emory University School of Medicine (Atlanta, USA).
Chet Moritz, co-PI of the Up-LIFT trial and associate professor in the departments of electrical and computer engineering and Rehabilitation Medicine at the University of Washington (Seattle, USA), added: “The start of this trial marks a significant milestone in bringing non-invasive stimulation to people living with spinal cord injury, whose top priority is restoring hand and arm function.”
According to ONWARD, a study recently published by Moritz and researchers at the University of Washington in Transactions on Neural Systems and Rehabilitation Engineering, demonstrated ONWARD’s transcutaneous spinal cord stimulation leads to both rapid and sustained recovery of hand and arm function for people with both motor complete and incomplete cervical SCI. These findings reportedly further support the potential for non-invasive spinal cord stimulation technology in restoring hand and arm function in this population.
The company states that an arc occurs when an electrical impulse bridges the gap between two conductors, and ARC Therapy is designed to re-establish severed connections between spared neural networks and the brain by means of specific, targeted spinal cord stimulation.