Where We Are Right Now | Kate Willette

Posted by Reeve Staff in Research News on April 03, 2018 # Research, Technology

Lately I’ve been reading and thinking and writing a lot about epidural stimulation (ES), especially in the context of the project known as the Big Idea. In the first post here on this subject, I described what ES is and why the Reeve Foundation is so determined to help get these devices approved for use in people with spinal cord injuries.

Briefly, because ES works.

When Dr. Susan Harkema’s lab implanted the first stimulator into the epidural space of a person with a chronic, motor-complete spinal cord injury back in 2009, he shocked the research community by recovering tantalizing bits of both autonomic function and voluntary movement. Among other things, he could move his toes. He could sweat. No one had anticipated that the device would trigger the gains that patient experienced; all of the testing since then has only confirmed and expanded those first results.

In the second post, I focused on a question a lot of us have been asking: what prevents this device from being available right now? Why doesn’t private insurance or Medicaid pay for people with spinal cord injury to go and get one? If the devices really do restore some function and this isn’t yet another instance of snake oil and false promises, what’s the holdup? None of us are getting younger!

The answer to that question involves the FDA and the issue of insurance coverage.

When it comes to these stimulators, the job of the Food and Drug Administration is to make sure they’re both safe and effective, and that means we have to collect enough reliable data to prove it. Without scientifically sound research, there’ll be no stamp of approval, no insurance coverage, no Medicaid coverage, and no devices. The Big Idea protocol was developed by scientists working hand-in-hand with FDA regulators; when the final data is published, we don’t want anyone to say, “This is nice, but it’s not what we need; go back and show us this other thing, too.”

Data is the key, but it’s just a fact that getting to the goal – effective ES devices readily available and fully covered – involves a certain amount of guesswork and re-grouping. We can’t know exactly what the health outcomes will be, or what new questions they’ll lead to. What we can count on is that this study will produce reliable, scientifically sound information.

So, where are we now?

The answer is, well into the beginning of the Big Idea trial itself. The planning and permissions are all in place, and the screening phase of the study began in early January 2018. Potential candidates undergo five days of assessments in Louisville, and then meet with Dr. Harkema and her team to discuss the results, eligibility and next steps.The study physician also makes a determination that the candidate is healthy enough to enter the trial. Lastly, the candidate and family must weigh factors such as the ability to relocate to Louisville, make the time commitment and be willing to undergo the surgery. These screenings are ongoing now and scheduled into June.

After the screening comes what’s known as “usual care” – the period of time during which the successful candidate returns home and resumes his or her usual activities.Two to three months later, s/he returns to Louisville for pre-implant assessments, followed by formal consent into the Big Idea study and – finally – implantation.Each Big Idea participant will spend two years in the study, undergoing a series of treatment interventions and assessments.

The basic question is this: Does ES work well enough to lower the cost of care so that it becomes a good bet for insurers? It sounds harsh when I put it in those terms, but if you’re the guy in charge of deciding what gets covered, that’s the equation you have to solve. If you don’t, your business will fail. In other words, there can be all kinds of reasons to want an ES, but if we can show that it leads reliably to better health and lower cost of care, that means – from the insurer’s perspective – that we need it.

So, think about the things that are routinely part of the insured cost of care for people with chronic spinal cord injury. In my house, for example, we’re looking at medications for bone density and neuropathic pain and urinary issues. There are supplies for bowel routines and for skin breakdown prevention. There’s equipment like the wheelchair, the specialized crutches, and the brace my husband wears on his right leg. He’s been in ICU a couple of times for skin infections that went septic, too, which was monstrously expensive. Generally a customer with a spinal cord injury is not a money-maker for the insurance provider, and that insurance provider would love nothing more than to pay once for an intervention that could mitigate the long-term payout. The costs I just named are only an example things insurers would be happy to stop paying for.

Before and after they receive their stimulators, each one of the volunteers will be measured nine ways from Sunday to see how exactly the ES changes both their overall well-being and their particular health indicators.Some of these will be obvious, like being able to use muscle groups that have been de-activated since injury, or being able to stand and fully bear their own weight. Others will need testing, like improvements in circulation, heart health, blood pressure, and temperature regulation. Patients will be evaluated for changes in bowel and bladder function, as well as the (much hoped-for!) return of sexual capacity.

There will be thirty-six of them, sorted into four different treatment groups by a method that makes sure the groups are balanced with respect to one another. Each person will be at least 18 years old and have an injury that’s at least 2 years old. All of them will be medically stable, not vent-dependent, and unable to stand. The precise details of what will happen in each of the groups are written up on this page of a government-maintained site that keeps track of clinical trials. If you’d like to be considered for enrollment in this study or any of the others at the Harkema lab, use this link to find the instructions for getting on their list.

Like you, I’m eagerly awaiting the first reports from the day the Big Idea becomes the Big Reality. I look forward more than anything to describing them right here.

Stay tuned.