Thomas returns with a couple of bad jokes and an introduction. Next speaker is going to be David Darrow, who works at the University of Minnesota. I think he got funding from the Matt team’s efforts at the MN legislature.
David Darrow: After years and years of failure, it seemed incredible that a device already on the market that I already knew how to install and had been installing …
- Disclaimer: funded by St Jude
- disclaimer: gonna talk about off-label use
- disclaimer: not an sci researcher; I’m a neurosurgeon.
Usually I’m in my lab doing nerdy things … (data visualized slides). And then someone pointed out to me that the cord is really just the bottom of the brain. And so we came up with a plan to do really, really, really deep brain stimulation. (laughs)
So he was at Hennepin County Medical Center, and during his time there he’d see a couple of new SCI patients every week … and that was about as excruciating as you could imagine. The worst is telling another family or patient that there’s nothing he can do.
So during that first six months, he happened to hear about Reggie Edgerton’s work. And he decided to go ahead and try his own trial. What are the barriers to clinical use? Reproduction and optimization. Once this thing gets approved, what are going to be the barriers to getting it to patients?
I knew that this was going to be a big problem.
So they started a human trial, with the goals of verifying current results and getting more numbers, and then removing the barriers to neurosurgeon deployment, which begin with getting the stimulator setting right.
He’s showing a slide with the 7 different MN orgs/groups that had to be part of any clinical trial he was going to get up and running. It was a huge team of partners who would all have to be involved in it. And we could ONLY do this because of the seed funding that we got through the MN legislature.
They do a lot of very complicated, risky surgeries, right? Surgeries that take 10 or 12 hours. This epidural stim surgery is 45 minutes, and very simple. Think about doing one of those vs. talking to the people who just got a new injury, week after week.
So, let’s think about SCI as a neuromodulation problem. The outcome would be volitional movement. They can adjust all kinds of parameters, which means there are tons of options even for the devices they have now. 160 different frequencies, 100 difference pulse widths, 256 different amplitudes. If you use Brute Force, you could try them 1 at a time and that would take 60 years. Instead they use what they call response surface modeling — a mathematical tool that takes input by the truckload.
LOL, they built an app so that patients who get the early devices can contribute their bits to that truckload of data. They already have this working. When there is data coming in from lots of patients all over the place, they can create a sort of map that shows what works and what doesn’t.
All those parameters … 60 yrs taken one at a time.
They use the Brain Motor Control Assessment … looking for volitional movement, but ALSO looking at things like urinary control, cardiovascular improvements, sense of well-being …
Now have approval and are ready to go. Enrolling their first six patients.
One of the least enjoyable things in medicine for me is the business side of things … it’s sort of slowed us down. To move things along as fast as we can, we had to find a good partner. We’re waiting to hear back from the FDA. As soon as we get preliminary data, we’ll be expanding.
We also have a colloboration with the vet school, because there are a whole bunch of dogs with spinal cord injuries. And we’ll be tracking that data as well.
@daviddarrow on twitter, Darro015@ umn.edu is his email