Since a sleepwalking accident 11 years ago at her Crosslake home, Kathy Allen has lived life paralyzed from the waist down. But she never gave up hope that her condition would improve one day.
After all those years, Allen recently shared groundbreaking results as the first patient in the E-STAND (Epidural Stimulation After Neurologic Damage) clinical trial.
"This last year's been way more hope than I've had in probably five years," Allen said at the first Minnesota Spinal Cord & Traumatic Brain Injury Research Symposium held Jan. 31 at Regions Hospital NeuroScience Center in St. Paul, where she talked about her participation in the E-STAND clinical trial. The video was available on YouTube.
The trial uses epidural stimulation to restore function and movement for people with spinal cord injuries. The study was set up to ask: Does epidural stimulation have an effect on patients, and does it restore autonomic function?
Allen had surgery at the end of September where a nerve stimulator was placed on her spinal cord and a battery pack was implanted on her left hip. After a month of recovery, Allen turned on the stimulator. She said it felt like a corset, with muscles working the abdomen.
About a month before the symposium, doctors saw success where "everyone was in awe," Allen said.
"We turned it on the default setting and both my big toes moved, and that is something that hasn't happened in 11 years," Allen said on the video. "So it was a rather emotional time. We're hoping that big toes lead to feet, legs and knees. We'll see."
Allen uses the stimulator, which has different settings, four hours a day. The stimulation has strengthened her core, leading to better balance, allowing her to sit up straighter and drive and ride in a car more comfortably, and making her able to push herself in her wheelchair more easily. Simply, her quality of life has improved.
Allen returns to Hennepin County Medical Center once a month where doctors record the different muscles moving.
"And it seems that I have movement. One downside is I don't feel movement. I have a sense, an awareness, of certain muscles that I try to move," Allen said. There is no expectation that she will get the sensory feeling back.
"They've proven it works for more people than they thought so the study is getting more attention," Allen said, noting the ultimate goal is that the trial will expand to the point where it can be used as a treatment option.
"If I had this (epidural stimulation) a year after the injury, I probably wouldn't be sitting here (in a wheelchair)," Allen said.
She hopes after completing this study doctors will extend her time of stimulation.
Allen is one of three people at Hennepin County Medical Center in the trial group so far. Up to 100 can be accepted. Allen has continuously searched for clinical trials to participate in, and encourages others like her to search clinicaltrials.gov. Over 150 people were considered for this trial - the first that didn't require preliminary rehabilitation - and Allen is the first female and the oldest patient in terms of years since her injury to be included.
"It's amazing where we're at right now," Allen said, stressing the importance of highlighting facilities the state has in the University of Minnesota and Hennepin County Medical Center.
Dr. David Darrow, of the Department of Neurosurgery at the U of M, is leading the clinical trial. He said of Allen at the symposium:
"She was one of the first patients that signed up for the study. She had had a really severe spinal cord injury. Her MRI was really concerning for us because she had very little spinal cord tissue remaining. We were really uncertain that this treatment would work at all for Kathy. And we talked about this specifically and she was willing to take that risk and so were we. ... She really changed how optimistic I was about this study."
Allen was called a powerful advocate for people with spinal cord injuries across the country and a volunteer for spinal cord research. Allen's goal is to continue to promote such research and to publicize the Minnesota Spinal Cord & Traumatic Brain Injury Research Symposium, which they hope to make an annual event.
This first symposium showcased new and innovative research funded by the Minnesota Office of Higher Education Grant Program, which funds research to discover treatment and rehabilitation with the aim of improving function in people with spinal cord and traumatic brain injuries. The initial funding for the trial came from a $6 million grant, provide by the state Legislature and disseminated by the Office of Higher Education.
In the meantime, Allen continues to live life to the fullest. She helps coach track at Pequot Lakes High School and she enjoys gardening in her raised beds at home. She and her husband, Larry, have three daughters and own Crosslake Storage Center. They are part of different groups - including Working 2 Walk and Unite 2 Fight Paralysis - and have attended symposiums across the country in search of ways to improve her quality of life.
Allen looks forward to what's in store as she continues down this path as a person with a spinal cord injury.