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Monday morning in the ballroom – Part 2

Posted by katewillette on April 14, 2008

Now a demo . . a woman named Kaitlin Smith from Biometrics is going to show us a new use of emt signaling — she’s a speech pathologist and she s going to show us how this works with this guy named Brandon who is here from Nebraska

He wheels up to her display.  She’s got electrodes already on his inner arms, which are allowing the machine to read his muscle activity in microvolts.

Okay, so Brandon is twitching a muscle and making the computer say out loud a phrase from a list on the screen  . . . the demo is going kind of rough, but it’s easy to see how much this would mean to someone with ALS, especially.

After some horsing around to get the sound to work, she shows a movie . . . a guy with ALS who can’t do anything at all . . . the neuroswitch allows him to use a computer to do basically whatever any other person can do with a computer. . . it’s wonderful, really.

Next is a neuroseurgoeon named Beverly C Walters who’s going to talk about neurostimulation for early spinal cord injury.  She’s the only civilian neurosurgeon working at Walter Reed.

She’s here representing Cyberkinetics, tho’ she doesn’t work for them — she’s independent.  Her job is to design clinical trials.  She’s here today to tell us about a device that looks about as big as an ipod.

She refers to the device as OFS; I’ve only heard rumors of this until this minute, but it’s intriguing. Right now it’s been used  only for semi-acute T injuries.  About 2 weeks post injury it’s implanted outside the spine, (not touching the cord, just the vertebrae).  It stays in for 15 weeks and is then removed.  It works by sending an oscillating current through the injury site, which as it turns out, causes axons to grow across.

So why should we care, if this technology is only for new injuries?   First because we spread the word, and second because the next iteration will be made for chronics.

The technology is based on the fact that nerves will grow toward a negative pole.  There are 240 publications out about this that involve studies with animals.  They’ve studied it with dogs who had naturally occurring sci.  They treated these dogs and sent them home.

There’s a video up af a nerve fiber growing toward a negative pole, but the one that’s trying to grow toward the positive pole is crapping out.  It turns out that  if you oscillate the poles, you overcome what’s called die back so that nerves grow in both directions.

They’ve used this device on 14 patients in a trial; the entrants were clinically complete ASIA A , no transection or gunshot wounds, there were 8 cervical and 5 thoracic injuries, each one got the implant within 18 days of injury and had it removed at 15 weeks.

What happened was improvement in sensation and motor, but mostly in sensation.  The light touch improvement went from an average of 30 to 60, , and the improvements in motor were small but measurable.

So, was the difference due to the device or spontaneous recovery?  Why spend the time and money ($250 million) to do a randomized big study?  Instead they compared what happened to their patients to those who were participants in the existing NACSIS III study . . . and the Sygen placebo group.  When these comparisons were done, the OFS stimulator patients did much better.  Good evidence.

The OFS patients also had NO neuropathic pain.  And a lot of them had bladder sensation as well.

What’s the safety issue?  There isn’t any.  The patients were glad they had it. She’s got a video up of patients talking about their sensation — bladder, bowel, sexual sensation . . . “you’re not laying there thinking about other things because you can’t feel what’s going on . . . I know how demoralized  and how weak I felt . . . when people say, ‘can I help you, can I help you’ it feels so good to be able to say ‘No, I got it‘.”

They’re currently waiting for FDA approval . . .

If you had cancer, they would pay for whatever you needed.  She says, “When I had cancer they paid for everything I needed, including reconstruction — and I would have given it all up if just one of you could have had access to this device.”

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2 Responses to “Monday morning in the ballroom – Part 2”

  1. Jennifer said

    The second demonstration was from Caitlin Smith from Control Bionics – http://www.controlbionics.com – which uses EMG signals to communicate with a computer.

    The third demonstration was from Dr. Beverly Walters, MD, discussing the Andara Oscillating Frequency Stimulator (OFS) device. Cyberkinetics offers the device It is not FDA approved, yet, but in clinical trials, applied to C and T level injuries. It can be implanted up to 18 days post injury. The device is in clinical trials.

  2. Klaimr said

    Jennifer for some reason you have not posted the Cethrin info site which is

    http://www.alseres.com/product-pipeline/product-candidates/cethrin.asp

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