What’s the Big Deal about The Big Idea? | Reeve Blogger Kate Willette - Blog - Reeve Foundation

Remember The Big Idea? I do. I remember vividly the day I sat in the conference room at the modest offices of the Christopher & Dana Reeve Foundation (CDRF) and watched the video they’d made to introduce their idea to the world. You can see that video yourself right here. At 38 seconds in, a young man named Rob Summers describes being told that he was never again going to feel or move anything from his chest down. “Including,” he says meaningfully, “my arms.” Rob had been a star pitcher in college baseball.

At one minute and eight seconds in, another young man, Kent Stephenson, recalls being told about the nature of his injury. “The doctors came in and they explained to me that I’d broke T5 and T6 in my back, and that I had a complete injury, and that there was, uh … basically that there was no hope for me to regain any mobility or movement.”

No hope. My eyes filled with tears right there, because I’d also heard that message. I heard it from a doctor after waiting for hours in the Emergency Room on the night my husband broke his neck. “Do not be hopeful,” the man said. In the film, Kent pauses just for a beat before he finds the words to repeat that terrible news; for me that little half-second stumble held a world of remembered loss and despair.

To heck with that.

On October 9^th, 2014, a few weeks after my visit to their headquarters, CDRF formally launched The Big Idea. If your injury happened during the last three years, it’s possible you haven’t heard of it, or have heard of it but were told that it failed and had to be scrapped. My project here is to catch you up on the real story. The plan is to deliver a set of short, to-the-point posts that will lay out answers to these questions:

• What is The Big Idea? How and why was it created in the first place?
• What was going on between late 2014 and late 2017? What was it that took three whole years?
• What can we expect to hear during 2018?

A poet once said, “A little learning is a dangerous thing.” He meant that we get into trouble when we think we know more than we actually know. At the other end of the spectrum is the problem of trying to know everything before we dare to make any move at all. With respect to the science behind The Big Idea, finding the sweet spot between those two extremes has been the obsession of CDRF for the last thousand days. The task has been to know just exactly enough to be able to see what to do next, to do that next thing, and to learn what must be known in order to see the next move forward. It’s much more complicated than it sounds, and while I’m just as impatient as everybody else, I’m also deeply grateful for people who don’t waste time by throwing their effort in directions that have almost no chance of paying off.

So, let’s begin. What’s the Big Idea?

The Big Idea is really two sides of a single coin. One side of the coin is a study to test, precisely and methodically, what an implanted epidural stimulator (ES) can do for someone with a spinal cord injury. What’s an epidural stimulator? It’s a tiny array of electrodes that generates a very small pulse when directed to do so. It’s called “epidural” because is fits deep inside the body, in the epidural space just outside the spinal cord. You can see a quick explanation of what that looks like at two minutes and two seconds into the video I pointed to earlier. Our current situation is this: we know that an ES causes positive changes in damaged cords, even years after injury, but we don’t know exactly how to make the most of those changes. That’s what the study side of the coin is.

It’s a carefully designed protocol for implanting epidural stimulators into the lumbar spines of 36 volunteers and then gathering specific data from each one of them over a period of the 18 months post-implantation. Because these volunteers will be entering the program on a rolling basis instead of all at one time, the whole project will take six full years. This protocol had to be approved in every detail by the Food and Drug Administration (FDA), because the road, my friends, to having this product safe, available, and fully insured goes through that institution. The FDA is the gatekeeper.

The other side of the Big Idea coin is a campaign to raise the funds to get the necessary testing done. The Christopher & Dana Reeve Foundation committed to funding this project itself through money raised by outreach to our community – seeking support from those of us with a direct interest in the outcome, as well as from other foundations aligned with our interests. Their original estimate was that the entire six-year project would cost $15 million. Because they saw that in the long run it would save time to build out the knowing-testing-perfecting cycle by creating a fully funded, long term, end-goal-based plan. So that’s what they did.

That’s why it was such a milestone when the Foundation announced last month that the FDA had finally given its full approval for the project. Next time, I’m going to spend a page or two going into detail about how that happened and why it took so long.

Stay tuned.

Note: There are companies and clinics in other parts of the world that are falsely advertising epidural stimulation treatments and may pose a danger to the paralysis community. Please read the Reeve Foundation's statement on off-shore stimulation treatments.