Woman paralyzed by fallen tree finds hope with newly FDA-cleared device
Nearly 12 years ago, Jessie Owen's life changed forever.
"My family was going over a mountain pass and a tree fell on our car. In that moment, my parents passed away, my siblings were severely injured, and I became quadriplegic," Owen said. "I lost my independence. I lost my job. I lost my apartment. I lost my autonomy and the life that I dreamed for myself."
Like Owen, more than 300,000 people live with spinal cord injuries in the United States, with an estimated 18,000 new cases each year, data shows.
Motor vehicle accidents account for the majority of spinal cord injuries and are closely followed by falls, acts of violence and sports activities, according to the National Spinal Cord Injury Statistical Center.
For years, options for recovery have been limited, but a newly FDA-cleared external spinal stimulator, ARC-EX Therapy, which received clearance on Dec. 19, may offer hope for people like Owen.
"ARC-EX is simply electrodes attached to skin on the back of the neck," explained Chet Moritz, Ph.D., a professor of rehabilitation medicine at the University of Washington. "It allows us to pass current through the skin to activate the sensory nerves as they enter the spinal cord. Now, those sensory nerves make direct connections to the motor nerves which help people to move."
Owen, who participated in the Up-LIFT study, a clinical trial focusing on the health benefits of ARC-EX Therapy, saw a life-changing impact.
"I was wildly surprised and pleased to see that it was making meaningful change in my life. I can now paint with my hands. I can open a jar of peanut butter. I can tie my shoes. It [used to] take me 30 minutes to get dressed. Now it takes 12. [I used to require] 20 caregiving hours a week and I was able to move down to about eight."
The Up-LIFT study produced promising results.
Of the 60 patients with cervical spinal cord injuries studied, 72% saw improvements in hand strength and function. Participants also reported fewer muscle spasms, better sleep, less pain, and improved independence during daily activities.
"The success of [this] study of people with spinal cord injuries is phenomenal," noted Moritz. "There are essentially no current therapies for chronic spinal cord injury, and so having the majority of patients respond in both strength and function measures [is] just an outstanding result."
With FDA approval, ARC-EX Therapy is expected to become more accessible.
"Patients can work with their local rehabilitation clinics to see a therapist and work with them in the clinic at first to tune the device," Moritz said. Results may appear quickly -- some participants noticed changes within just a few sessions, he added.
While the device is currently cleared for improving hand strength, function and sensation, Moritz noted other benefits: "Some people will have modest improvements in their bladder function, heart rate, or blood pressure control."
Leah Croll, M.D., vascular neurologist at Maimonides Health and assistant professor of neurology at SUNY Downstate, shared the excitement over the device.
"The idea that ARC-EX Therapy may accelerate or augment neurologic recovery is really exciting. Any improvement in neurologic function is meaningful and has far-reaching impact in the daily lives of these patients and their families," she said.
The road to recovery after a spinal cord injury is grueling, Croll said.
"After emergency and ICU care is completed, the mainstay of treatment is working closely with physical therapists, occupational therapists and other rehabilitation professionals to support neurologic recovery," said Croll. "Patients may also need medications and certain procedures, depending on their unique symptoms."
For Owen and others, ARC-EX Therapy represents a renewed sense of hope and an exciting change in the way these patients can be treated.
"[With ARC-EX Therapy], I continued to gain function back, and I found I was able to pour more into other people," Owen said. "The first indicator of success that I noticed was my own happiness. It works, and it gives us hope and passion."
Natalie S. Rosen, M.D., is a physician in the Hematology & Oncology Department at New York-Presbyterian Columbia and a member of the ABC News Medical Unit.
