A first-of-its-kind clinical trial at HCMC in Minneapolis is giving hope to people with spinal cord injuries. While results have varied among about 20 trial participants, the takeaway so far is that people can regain function after spinal cord injuries and not merely maintain whatever limited mobility they have, said Dr. David Darrow, lead investigator.
The trial could be the first that compels the U.S. Food and Drug Administration to approve a device that restores function after spinal cord injuries, he said. “So this, using neuromodulation, is exciting, because if we get a positive change then hopefully it means we can parlay that into bigger and bigger changes.”
Crystal LaBo was proof at her third follow-up appointment at HCMC after having the stimulator implanted in March. When the device is active at certain settings, she can lift her legs and bend her ankles — limbs that had been immobile for 23 years after LaBo was injured in a car accident.
While relatives and friends are amazed by her newfound movements, LaBo said they are largely for show because she can’t yet put enough pressure on her legs to stand or walk. Far more meaningful are the hidden benefits. The stimulation has stabilized her blood pressure, eliminated extreme temperature swings and allowed her to urinate without using a catheter. She maintains an active, independent lifestyle as the mother of four children and the co-owner with her husband of two restaurants.
Darrow said FDA approval could be swift if the HCMC trial succeeds, because the stimulator is widely used for pain management. Most people with severe spinal cord injuries only have a fraction of their nerve fibers still capable of sending signals from the brain to lower limbs.
“Clinically we don’t see any movement, we don’t see any function at all,” he said. “When we turn on the stimulation on the bottom of the spinal cord, it’s actually changing how receptive it is to those remaining fibers. … We’re just revving up the spinal cord so it’s better able to receive.”
(Source: Star Tribune)