Dustin Shillcox has recovered

The Big Idea: Does Recovery Trump Cure in Spinal Cord Injury?


In mid-October, the Reeve Foundation unveiled its candidate for SCI recovery — epidural stimulation — as the centerpiece of its ‘Big Idea’ fundraising campaign.

Unlike most news stories that exploit the latest “paraplegic walks again” cure angle, The Big Idea emphasizes important quality-of-life gains made in a phase one trial involving four paralyzed subjects in the past three years. Referring to an April 2014 journal article in Brain, a Reeve public relations spokesperson stated that the four had regained “voluntary movement in their legs, hips, and toes,” but also regained “major autonomic functions, including body temperature, sexual function and bowel and bladder control.”

The main purpose of the Big Idea campaign is to fund the next phase of epidural stimulation research involving 36 more SCI subjects (www.ReeveBig Idea.org) and includes an appeal for the paralysis community to participate in a crowdfunding campaign. When the press release arrived, those of us on the NM editorial staff began weighing the prospect of getting behind The Big Idea.

“This is a BFD, in the immortal words of Uncle Joe Biden,” offered managing editor Josie Byzek. “It has created a lot of buzz. We should definitely do a major story on it.”

Dustin pull-upsSenior correspondent Bob Vogel got caught up in the everpresent subtext of cure. “I’m coming up on 30-years post-injury and I remember watching Petrofsky [an early proponent of functional electric stimulation] on 60 Minutes a few years before my injury when ‘walking after SCI’ was said to be about five years out. In 1985 the ‘cure is coming’ was thrown about a lot — I think the Miami Project also used the ‘five-year cure’ curve. For me it seems like all the ‘cures’ have a magic time of ‘within five years.’”

Vogel went on to recount a story he wrote in the late ’90s when he interviewed four or five young men with SCIs who had been conned into doing “shark cell surgery” by a charlatan in Mexico. “A year later nobody had any return, but a couple had developed a lot of neuropathic pain in their legs. The charlatan doc was telling them ‘that is your body turning on the circuits, that means you will be walking soon.’”

Vogel says he is grateful for the things the Miami Project and the Reeve Foundation have done to improve life with SCI. “On the other hand,” he says, “at this point, with severe osteoporosis and multiple leg fractures, I like [former NM editor] Barry Corbet’s quote: ‘Forget about curing SCI, I want a cure for old age, and I want it now!’”

All that aside, Vogel thinks epidural stimulation is worthwhile, especially “if it can bring about simple (sounding) benefits like improving bowel, bladder and sexual function.”

Rob Summers
Rob Summers

What Now?
The epidural stimulation “breakthrough” reported in Brain is not as current as the Reeve press release implies. I reported on it in a major NM cover story three years ago (“Rob Summers: From Quad to Para and Beyond?” September 2011) and again in a subsequent story. What makes epistim unique is that it combines retraining the “intelligent” spinal cord with implantation of a stimulation device below the damaged area that amps up “excitability” and theoretically completes the circuit to the brain. The pioneering researcher, Reggie Edgerton, likens it to the effect of a hearing aid. It amplifies a nonfunctional signal to the point of functionality.

Like Vogel, my recollection of “cure stories” goes way back, all the way to 1966 and an article I read in the Los Angeles Times declaring paras would “walk again with bioelectric stimulation.” I saw the research firsthand in Yugoslavia in 1971 — it worked for people who had foot-drop as a result of strokes but not paras. That was the forerunner of the Petrofsky era and FES, which while helpful, is clearly not “functional.”

Still, epidural stimulation is exciting in more ways than one, especially if we are really talking about freedom from pressure sores due to building up of muscle, temperature regulation for quads, better sexual potential, bladder and bowel improvements, and better bone health — all for large numbers of people.

But how will the lessons learned from the 36 subjects in phase two be translated into locomotor training, affordable equipment and training for hundreds of thousands of people with SCI who may or may not benefit? Who will make it happen?

Probably not the insurance companies and Medicare, unless it can be proven that the cost of LT and epidural stimulators and therapists and program funding will bring about a quick and lasting savings in annual costs to treat SCI. It means spending more money now with no immediate return on investment, something that prevailing business models in the U.S. and our Congress are not eager to take on in the face of our current economic situation.

As for the propriety of crowdfunding by tapping into the paralysis community, I suppose that should be up to individuals to decide for themselves.


In seeking more information on the background and potential of The Big Idea, we decided to ask Sam Maddox, founder of NEW MOBILITY and former knowledge manager for the Reeve Foundation, about his perspective on the past and future of epidural stimulation

Dustin Shillcox has recovered some movement in his legs as a result of epidural stimulation.
Dustin Shillcox has recovered some movement in his legs as a result of epidural stimulation.

TG: What makes epidural stimulation different from other promising treatments?

SM: Beginning back in the early 1980s, I too, heard the cure-in-five-years line a number of times. It’s helpful to remember the source, often an agency fueled by donations from hopeful families in the SCI community. It is also important to know that back then the basic grasp of regenerative science was unsophisticated, even among some scientists. The consumer public had very little to go on but faith in short-term results from what was indeed a long-term project.

There were great strides made in the ’80s and ’90s, revealing that spinal cord nerves could grow again if they were provided a more hospitable environment. Decades later, we know that it’s more than the toxic microbiology around the injury site that has to be modified. The nerve cells themselves have to be repowered. But even a juiced-up axon, or a new one by way of a stem cell, isn’t enough — this all has to be directed and connected to the right targets. That is not at all a trivial issue; reaching the wrong target could mean pain or unwanted motor activity. So, while the idea of regeneration has been broken down into its many essential molecular elements, no one has figured out the whole thing: Is it possible to regrow the long axons that are the connection between brain and legs? Yes, in animal models. But not yet in people.

What’s cool about the epidural stimulation story is that it does not depend on the regrowth of long-tract nerve fibers. It doesn’t really depend on the brain at all. Epidural stim takes advantage of existing spinal cord nerve networks that are intact but dormant. It gives them the right information to carry on important activities that are for the most part automatic in the body. You’ve all seen the four guys in the phase one epistim trial with their legs moving on command (www.youtube.com/watch?v=mp8wFYu4l4w). What is overlooked is that the nervous system is also changing and adapting — some functional recoveries remain, even when the stim is off.

TG: Why does the paralysis community have to pay for research if it’s so promising? Why not the National Institutes of Health. And will it really cost $15 million for 36 test subjects? That’s $400,000 per person.

Drew Meas, Dustin Shillcox, Kent Stephenson and Rob Summers all participated in a study of epidermal stimulation that resulted in what the Christopher and Dana Reeve Foundation is calling “huge improvements in their ability to control autonomic functions and move their toes, feet and legs on command.”
Drew Meas, Dustin Shillcox, Kent Stephenson and Rob Summers all participated in a study of epidermal stimulation that resulted in what the Christopher and Dana Reeve Foundation is calling “huge improvements in their ability to control autonomic functions and move their toes, feet and legs on command.”

SM: I know the agency that funds this work at NIH, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is stoked about it, and wants to help move it toward clinical application. They are hosting a meeting in mid-November with the labs, the funders, the big product makers (Medtronic, Boston Scientific and St. Jude Medical) to discuss next moves. Fiscal year 2014 budget for NIBIB was $326 million; one would think the agency could find the money — indeed, NIBIB has already granted at least $15 million at the UCLA, Cal Tech and Louisville campuses to support this work. As to whether $400,000-plus is the right number per subject, these clinical trials are expensive, no doubt. That number is certainly a far higher cost than the stim unit and the surgery, as it is commonly billed for pain treatment. Add in a bunch of rehab, even every day for a year, and it still doesn’t seem to add up. I guess you have to figure in some admin overhead [Editor: also, phase two is aiming at collecting far more data, according to the Reeve press release].

Let’s say they go 36 for 36 and everybody is autonomically happy with their recovery. Then what? The group at the University of Louisville that the Reeve Foundation is backing to do the stim surgeries is not the right place to ask. They do science. They don’t make or market products or get FDA approvals.

As the human experiments continue, there is a company in Los Angeles making a next generation stim unit (the Big Idea unit is made for pain and is regarded by the researchers as suboptimal for SCI). NeuroRecovery Technologies, formed by Reggie Edgerton at UCLA [whose decades of research provides the basis for the trials], has tested new devices that may relegate the old ones to the Model T era. Researchers are not capable yet of putting these new ones in people, but once they get going, NRT will be among the first to figure out the reimbursement issues. The stimulation market for the pain device being used here is huge, estimated to be $4.5 billion in 2016. These kinds of devices are routinely implanted and paid for in people with back pain. There are Medicare codes that cover any number of implantable pain stim units.

I’m sure there will be ways to prove epidural stimulation not only improves health and quality of life, but also saves a ton of money — in urologicals, for example, or in medical care — and this technology is therefore an investment in public health that must be made.

TG: What about locomotor training? Is that still an essential part of the whole procedure?

SM: Locomotor training will be part of the mix; besides the e-stim there will be a training component — this is how they first figured out the sensory-input-wakes-up-the-smart-spinal-cord concept. And it will be used to maximize recovery. A third variable is development of a drug that amps up spinal cord sensitivity — they have one that is important in animal models but nothing yet for people.

TG: So back to the timeline question. I know you don’t have a crystal ball, but is there any way you can ballpark approximately when these units might be available to implant in large numbers,
assuming all goes well with research and product development?

SM: You will laugh. Five years. That’s actually within reason.


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