Kim is back to moderate the questions.
Q: Talk about the recovery parameters … you didn’t mention sensation. Anything to report on there or regarding pain or spasticity?
A: Sensation does improve, though it has sometimes been spotty. Spasticity has kind of jumped around. I don’t want to mislead you or overstate anything, but I can say that everything is moving in the right direction.
Kim makes a comment that it’s important that there be data to say what we know about improved autonomic function — not just anecdotes.
A: When we did the first study, we were going for movement. The secondary endpoints are autonomic function. What Reg and the team have decided is to divide up the tasks. One center will look at bladder, another ventilation, another sexual function. What we know is that there’s a way to fine tune these studies so that we can deliver an evidence-based product. We’ll know before anything is released that it does work. The FDA will approve us for these things one at a time.
Q: One exciting thing is that we get to stop thinking of complete/incomplete paradigms. What we don’t have is a standard of care for people participating in activity-based programs. I’m 20 yrs post and I’ve been involved in these programs for 3 years and am getting functional return. She’s making a speech, but I don’t hear a question …
A: Carrie talks about what they do at their center in Minneapolis … they’re taking people who seem to have plateaued off their programs and putting them into the stimulation programs and seeing more improvement.
Q: Thanks Nick for caring so much. Is there an outside limit in terms of time since injury for either of these kinds of therapies.
A: Carrie says no, no limit. Nick says they just had a small breathrough a couple of weeks ago. Up until then their patients were all under 10 yrs post — but they had an Asia C 21 yrs post injury get hand function improvement and improved ability to stand. Goes on to say that the ability of the human body to repair itself can’t be underestimated. Carrie says that in the case of NMES, it does take a lot of time and a lot of work — not a fast process like epistim can sometimes be.
Q: Does the strength and endurance continue to grow over time?
Q: Are you two in competition with each other?
A: No, we’re synergistic. We’re creating the new doctor’s black bag, which doctors will use in the future. There are already people who have combined epistim and NMES. And Mark Pollock has shown that combining epistim with exoskeleton makes for a 4-fold improvement over either one alone.
Q: Can you describe exactly what happens in epistim? How does it fit into your business model?
A: When we stim, we’re targeting interneurons, and then proprioception comes into play … if the cord is turned on and awake, the proprioception kicks in. The more we combine stim with sensory input, the better it works. The stim device is acting like a hearing aid; it filters out the noise and lets whatever the signal is to come through. Reggie had a theory in 1969 that the cord was as sophisticated as the brain. We just got movement from two stroke patients … stroke is in the brain, right? So it’s the cord that’s changed.
Q: Have any of your subjects reported neuropathic pain or anything like that?
A: When we stimulate, we’re able to pinpoint a narrow funnel of energy going into the cord. We’ve had some situations — we had one person with AD who it was challenging to keep stimulating. And there was one subject who had — not complications, but a lot of spasticity. There were a lot factors affecting this person, including an accident that happened outside the university. We’re very hopeful that once that individual comes back into the study we can get him back to improving. The delay has to do with the health care system as it currently exists.
Q: For those of us who are 30-40 years out, how big a problem is bone density?
A: That’s one of the long term studies we’re getting underway. i don’t think at this point it prevents anybody from taking part in what we’re doing now. (Kim steps in to say that you lose bone density within a few weeks.)
Q: I’m an SCI physician wondering about forward thinking in terms of making this therapy available?
A: Nick says that they’re going to be attacking this one now that they (as of next week!) will have long term funding in place. This new set of tools is going to be sending data in real time back to doctors, which will raise the standard of care — the fact that all this technology will be delivered wirelessly will eliminate a ton of barriers in terms of ability to simply get to a doctor’s office. Carrie says that her patients have been monsters when it comes to getting their own care covered by their insurance. And they’ve had to be.
Q: We know that both Dr Harkema and Dr Lee had the whole “pre-hab” thing going. What do you say to the people here about optimizing their ability to take advantage of these technologies?
A: Stay healthy. We started stimming people without training, and it still worked but not as well as it did for people with training.
Q: it’s very frustrating that some improvement is documented and some is anecdotal. Why are you planning to do multiple studies to check each kind of improvement? Also please be very careful with using the word, recovery … it’s so difficult for us to know what to expect.
A: the problem is that it’s all so early … and that there’s only so much money to do each particular test. But be assured that in order to get something approved, it will require a different set of stimulator parameters. The FDA will be looking at the true benefit vs potential risk, for each organ system in isolation.
Q: so is there a bladder study planned in addition to bowel?
A: there’s a bladder study right now at the VA in Long Beach. Carrie says that in her case, they’re looking for outcomes BECAUSE their clients are reporting those kinds of improvements.