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How a New Device is Improving the Lives of People With Spinal-Cord Injuries

MSPMag   (MSP)

By: Sheila Mulrooney Eldred 

April 17, 2019

When Kathy Allen left the hospital, following a 2006 sleepwalking fall from a second-story deck, doctors told her she wouldn’t be able to walk again. That was hard to hear, of course, but she believed she could accept it. Much harder—difficult to even imagine—were the “little” things Allen would no longer be able to do, such as going to the bathroom when she felt like it, or sitting without wobbling.

“Excuse me?!” she remembers thinking. “I did not sign up for that.” 

Regaining the ability to walk may look like a “cure” for paralysis. But people with spinal-cord injuries will often identify quality-of-life issues they want as much as (or more than) ambulation. This list includes the ability to control bathroom needs, avoid wild blood pressure swings, and enjoy sex. Sandra Mulder of Ottawa, Canada, who sustained a spinal-cord injury in a motorcycle accident almost seven years ago, wants to be able to stand for 30 seconds at a time. This would make it easier to get dressed or transfer from her wheelchair to a car. 

A little over a year ago, through a University of Minnesota study on spinal-cord injuries, Allen became the first of just seven paraplegics to get an epidural stimulation device implanted in her spine. Mulder became the second a month later.

That device, a slim, battery-powered pack that stimulates spinal-cord nerves, has restored the testers’ ability to do some of those “little” things. (For more on how the device works, see “Wired Up,” bottom of article.) For Allen, a track coach and mom of three daughters in Crosslake, Minnesota, the newfound ability to sit up without slouching means she digests food more easily. And her stomach no longer spasms every time she goes over a bump in the road when driving. It also means an end to shoulder pain, and leg spasms in the middle of the night. It has cut the time it takes to go to the bathroom from over an hour to under 30 minutes. (Bladder and bowel function rely on communication between the brain and the lowest part of the spinal cord.) 

For Mulder, regained energy means she works an extra hour or two at her job managing a dental office, and then makes dinner instead of watching TV. Her body temperature can regulate itself. (Heat and cold signals also travel along spinal-cord nerves.) 

These improvements, the two women say, have proved life-changing.

The success of these first two participants similarly amazed researchers at the U of M and Hennepin Healthcare. In response, their ongoing clinical trial, called E-STAND (Epidural Stimulation After Neurologic Damage), published its findings early. Allen and Mulder represent unusual subjects for such studies: Allen is 53 years old and Mulder is 49; they’re women; and both are several years removed from their injuries. In fact, researchers shared their doubts with Allen beforehand, hoping to stave off disappointment if it didn’t work. When doctors turned on the device for the first time, on the 11th anniversary of her injury, Allen moved her toe on cue. And everyone in the room cried. 

Epidural stimulation “may be beneficial for a lot more people with spinal-cord injuries than we ever anticipated,” says one of the study’s three lead investigators, Dr. David Darrow, a neurosurgery resident at the U of M. Eventually, epidural stimulation could be helpful for many of the 240,000 to 337,000 Americans living with spinal-cord injuries. Part of its potential comes from affordability: The study showed for the first time that the devices alone can foster movement. Patients still will benefit from rehab after the implant, but the protocol can be cheaper and less extensive. That cuts costs from about $400,000 per participant to about $35,000 to $40,000.


It was no coincidence that this study aligned with the wishes of people living with these disabilities. 

Since his son sustained a spinal-cord injury in a body-surfing accident 10 years ago, Matthew Rodreick has devoted his career to helping people with spinal-cord injuries through a pair of nonprofits. He advocated for a 2015 bill that provided $1 million for state research on spinal-cord and traumatic brain injuries. In 2017, Minnesota allocated $6 million, and will be considering a $10 million funding request in 2019. (About a dozen other states already had similar legislation.) Since Minnesota’s bill passed, Rodreick and his Unite 2 Fight Paralysis have successfully lobbied for bills in Washington and Pennsylvania. They’re expecting to add Ohio this spring. 

Beyond the money itself, the legislation includes people with paralysis in reviewing and approving where it should go. That’s how the E-STAND study won funding. 

“We have not been a part of the process,” Rodreick says. “We need to be. It hasn’t been built to provide what the community needs.” 

Rodreick has an ambiguous response when he sees headlines trumpeting paralyzed people who can now walk again. Those cases cost hundreds of thousands of dollars per patient and require years of rehab. At the end, the participants still rely on their wheelchairs to get around.

“It seems like paralyzed people are walking, when actually they’re taking steps with controls and assistance,” he says. “What the majority of people with spinal-cord injuries would want is not walking. They want the return of bladder, bowel, thermal regulation, cardiovascular regulation, hand function. And they want to have sex. All those things come before walking, but it’s rare to ever see that mentioned.”

Advocates didn’t have to convince Dr. Ann Parr, a study co-investigator and an assistant professor at the U of M. Early in her training as a neurosurgeon, Parr met patients with spinal-cord injuries, and listened to their actual needs and desires. 

Research should help people return to walking, too, she points out. “We don’t want to say this is good enough,” she says.

A complete cure, Parr says, likely will demand “a bag of tricks,” rather than one universal miracle treatment. (She’s betting that it will involve spinal-cord regeneration. Her work transplanting stem cells from a patient’s skin and blood to the spinal cord has also received funding from the Minnesota bill.)

In the meantime, epidural stimulation, Parr says, has “surpassed our wildest expectations.” It has already changed the conversations that doctors have with patients facing paralysis.

A decade ago, doctors used to tell patients with clinically complete spinal-cord injuries that they had a very small chance of getting any function back. “If a person comes in today,” Parr says, “I’ll tell them, you will probably get a spinal-cord stimulator in the future”—although it may not  fit the bill for every patient, she adds.

Allen, who says she’s never giving her device back, views it as a way to bridge the gap until a complete cure comes along. 

The list of people with spinal-cord injuries hoping to join E-STAND includes more than 500 names. So far, the Minnesota researchers have implanted seven people, all with positive results. One participant even astounded researchers by regaining sexual function. They’re looking to add at least another 10 to 15 subjects to “really tell if it’s working,” Darrow says. This would also make it one of the biggest studies in the world using epidural stimulation for spinal-cord injuries. 

Getting the devices on the market (and covered by insurance) will take FDA approval. That likely means another five to 10 years, optimistically. In the meantime, people can pay for the devices themselves.

Rodreick’s hope is that the publication of this study will prompt more research. The first E-STAND participants are eager for others to enjoy the benefits of epidural stimulation. 

“I have so much hope now, not just for myself, but for so many others,” Mulder says. “We’re not on the cusp anymore. It’s happening.” 

Wired Up

How does epidural stimulation work? 

To start, it helps to understand a nuance of paralysis injuries. Most paraplegic patients don’t suffer from completely severed spinal cords. 

“The vast majority are more like a bruise or a punch to the spinal cord,” says Dr. Ann Parr, a study investigator and neurosurgeon at the University of Minnesota. “It’s like a switch to a light bulb. If you cut the wire completely, it won’t work. But, if you cut the wires just partway, it may flicker a little or short out.” 

Epidural stimulation is like adding a battery pack to give those damaged wires a boost and reestablish a connection. 

To outfit someone with an epidural stimulation device, neurosurgeons implant an array of electrodes below where the spine has been injured. A battery-powered controller—which looks a bit like a computer thumb drive—sends the electrical signals.

So far, qualifying patients have signed up for the U of M trial (called E-STAND) on a first-come, first-served basis. The outpatient surgeries to implant the devices, donated by Abbott, have been performed by Dr. Uzma Samadani at Hennepin Healthcare. 

Using a transponder, clinicians can tinker with the device settings afterward. In lieu of onsite rehab, E-STAND participants do at least 15 minutes of daily movement “homework,” and answer questions that allow the researchers to fine-tune the functionality. 

At the end of the 15-month study, participants keep the devices—which suits patient number one, Kathy Allen. “They can upgrade it all they want, but they don’t get it back!” she says.

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