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  • Epidural Stim Implementation time too long!!!

    Since the first person was transplanted with a Epidural Stimulator it has now been 5 years. From all they say the results can be pretty immediate, so that's five year's they have known it can help so many people even in a non complicated form using a low channel stimulator. This is rather disturbing to me as I sure would like to work towards some goals toward recovery even after 34 years of T4 SCI perhaps even pushing a little more on my FES bike when I work out, a little sensation towards sexual function or improved bowel and bladder activity, even if small gains. I know, FDA regs, lawsuits blah, blah, blah. Even if there were a legal form to sign holding them not accountable for any possible bad side effects, I'd sign it. Heck they could charge big bucks and I'm sure there would fund raisers to get those who could not afford to have it done get it. Even if it had to be done in another country like Mexico or whatever, there's gotta be a way. I want these gains now, even if small before I get too much older and I'm sure a lot of others feel the same. Epidural Stimulation for pain has been around a long time https://www.medtronic.com/patients/c...rs/what-is-it/ The risks are low, it can be removed at anytime, not that big a deal. I just don't see what the hang up is? I know red tape, blah, blah, blah. A lot of people could be improving from it NOW including people with reduced hand function from all I've read, why are so many things kept away from us? to me it's just not right and down right mean showing all these gains and good things happening in a select few and keeping it out of the mainstream from people who could really benefit from these things.
    Last edited by Curt Leatherbee; 05-18-2015, 05:45 PM.
    "Life is about how you
    respond to not only the
    challenges you're dealt but
    the challenges you seek...If
    you have no goals, no
    mountains to climb, your
    soul dies".~Liz Fordred

  • #2
    Nothing has ever gotten to the clinic in 5 years from someone being implanted with something being researched Curt. (Stem cells, drugs, devices...) Not with SCI, and probably not for other patient groups either to be realistic about the situation. It's not about someone trying to be mean to SCI folks. Let's at least get the facts straight.

    Start the tape at about 3:42:00 for Europe's G-therapeutics presentation.

    https://www.youtube.com/watch?v=dc_-mwJ-7As
    Last edited by GRAMMY; 05-20-2015, 08:16 AM.
    http://spinalcordresearchandadvocacy.wordpress.com/

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    • #3
      Wait is really hard

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      • #4
        Darn the video is blacked out. This all really is very exciting though http://www.reevebigidea.org/ I dunno, maybe Peter is worth the salary he earns, their website looks great and organized and he is really pushing to try and make things happen. Sometimes you gotta get somebody who commands that kind of salary to get things done and make things happen.
        "Life is about how you
        respond to not only the
        challenges you're dealt but
        the challenges you seek...If
        you have no goals, no
        mountains to climb, your
        soul dies".~Liz Fordred

        Comment


        • #5
          Originally posted by Curt Leatherbee View Post
          Darn the video is blacked out.
          I dunno, maybe Peter is worth the salary he earns, their website looks great and organized and he is really pushing to try and make things happen.
          Sorry about the black out. Click this link at youtube and slide up to 3:42:00 to hear the translation strategies of G-Therapeutics from the Day 3 Brain Forum. https://www.youtube.com/watch?v=dc_-mwJ-7As

          It's a continuation from the Day 2 Presentation done by Courtine on this video starting at 9:15:00
          https://www.youtube.com/watch?v=RAOD_9MIbO0

          It's Peter's job to be a fundraiser. He needs to raise 15 million for another 5 years worth of research being scheduled in Kentucky to find additional benefits to stimulation and a nice website is critical to his efforts. But, unfortunately, that's only a start of what it's actually going to take to make it to fruition...

          Also, the Medtronic pain stimulator doesn't have near enough electrodes to complete the circuits for fluid movement. Harkema has explained in great detail that the crude 16 pain array she's been using the past few years is only giving them proof in concept in the research. That is why Reggie's group from Cal Tech (Joel Burdick) started building the sophisticated array that will allow fluid movements instead of each circuit needing to be shut off before the next one can be turned on. To be honest, there would be no reason to want the Medtronic pain device surgically implanted for locomotion when the new one has been developed and is on the verge of clinical trials with this new sophisticated prototype with NeuroRecovery Technology that have optimized the treatment to take to the clinic or the flexible one called the e-Dura with G-Therapeutics in Switzerland who's group is with Courtine. It will also dispense the known pharmacological cocktail that induces walking. Harkema and Courtine are both students that studied under Reggie Edgerton from UCLA. They're both building on 40 years of research work completed in the Edgerton Lab.
          Last edited by GRAMMY; 05-20-2015, 11:25 AM. Reason: added link
          http://spinalcordresearchandadvocacy.wordpress.com/

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          • #6
            Originally posted by Curt Leatherbee View Post
            Since the first person was transplanted with a Epidural Stimulator it has now been 5 years. From all they say the results can be pretty immediate, so that's five year's they have known it can help so many people even in a non complicated form using a low channel stimulator. This is rather disturbing to me as I sure would like to work towards some goals toward recovery even after 34 years of T4 SCI perhaps even pushing a little more on my FES bike when I work out, a little sensation towards sexual function or improved bowel and bladder activity, even if small gains. I know, FDA regs, lawsuits blah, blah, blah. Even if there were a legal form to sign holding them not accountable for any possible bad side effects, I'd sign it. Heck they could charge big bucks and I'm sure there would fund raisers to get those who could not afford to have it done get it. Even if it had to be done in another country like Mexico or whatever, there's gotta be a way. I want these gains now, even if small before I get too much older and I'm sure a lot of others feel the same. Epidural Stimulation for pain has been around a long time https://www.medtronic.com/patients/c...rs/what-is-it/ The risks are low, it can be removed at anytime, not that big a deal. I just don't see what the hang up is? I know red tape, blah, blah, blah. A lot of people could be improving from it NOW including people with reduced hand function from all I've read, why are so many things kept away from us? to me it's just not right and down right mean showing all these gains and good things happening in a select few and keeping it out of the mainstream from people who could really benefit from these things.
            Curt, you could go to Dr. Possover in Switzerland, pay 70,000 usd I think and get something similar done. I was trying to follow up on the results of his operation on one of his patients, a German singer, but things kind of got quiet after a while and info was not filtering out. The doc was initially funded by wings for life foundation but they stopped their funding, so that would raise an alarm bell, but worth investigating for you if you are really interested in this technology. Alain

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            • #7
              Agreed Curt. Very frustrating to know that something exists to help yet we don't have it.

              Kinda hate that saying, "The world doesn't owe you anything," when it's been 3 decades.

              From watching the videos, it takes some 'dialling in' to get the frequency right ... which seems to differ from person to person. Imagine all the time needed to train other surgeons etc. we're not even there yet.

              The b/b/s stories were anecdotal so I am staying cautious.
              Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

              T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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              • #8
                Clinical trials take a long time and are very expensive, (at least in the US.) ChinaSCINet has completed 6 clinical trials for $2 million, pretty amazing.

                We are working hard to get the Phase IIb trials going this year, and will apply for recently expanded Compassionate Use. Also, Dr. Young will be presenting his research at a Congressional Briefing next month. Things are coming together.

                Comment


                • #9
                  I am not exactly sure how all the FDA rep tape goes as well but do feel it is very very slow and frustrating. I am someone with a lower motor neuron injury and for well over a year I have been waiting for the FDA to approve higher pulse widths for electrical stimulation. LMNs do not respond you the standard pulse width in the US of no more than 0.5 ms and I have done experimental stim in clinics and had good response to 1.0 ms but this isn't available in the US for home use.


                  So we are talking about exterior electrodes nothing invasive. Something I have done in clinic with no problem something that is ok in Europe. I've imported my own unit and had to get clever with bringing it in through customs since it is not an FDA approved device and could technically be seized.


                  My point is something that that is used widely outside of the USA and something that can help a lot of people is not allowed here and in my opinion is taking forever to get approved. I cannot imagine how long and tedious a treatment or procedure takes.

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                  • #10
                    I totally agree. It seems like if there is something that works and there's no actual treatment; it is sinful to not fast track it. Ebola was fast track at lightning speed. Improved hand function for any SCI would greatly reduce cost… I wonder what insurance is not seeing this.

                    Out of curiosity – which bike are you using? Personally, have you noticed any difference in spastisity or bone density?

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                    • #11
                      Speaking of which, it reminds me that so far still no medical journal publication from the phase I nor II trial that debuted years ago and kept being postponed, again what's keeping it for being published? How long phase IIb will take this time? Could it have the same fate as PI & II at the end as being 'too specialized' for the reputable publishers? I'm not trying to be an ass, but as much I try to stay optimistic, I admit that my hopes from years ago in this trial are fading away.
                      Last edited by Moe; 05-19-2015, 10:00 AM.
                      "Talk without the support of action means nothing..."
                      ― DaShanne Stokes

                      ***Unite(D) to Fight Paralyses***

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                      • #12
                        I can tell you with complete confidence that the Phase II paper will be published and IIb will begin ASAP, followed by Phase III.

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                        • #13
                          Im just wondering if the benefits that the 4 guys got are even good enough that insurance companies, medicaid medicare, etc. will want to pay for it. Thats also got to weigh heavily on any investors minds.

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                          • #14
                            Its somewhat daunting to see my fate discussed in terms of recurring income and revenues. Thats a real wake up slap of reality!!!!

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                            • #15
                              Originally posted by Barrington314mx View Post
                              Im just wondering if the benefits that the 4 guys got are even good enough that insurance companies, medicaid medicare, etc. will want to pay for it. Thats also got to weigh heavily on any investors minds.
                              I think the venture capitalists have a firm market analysis before they move forward and invest in anything. As the one lady in the video explains, they're looking at these products as having a global market rather than just being marketed to one lone country. We'll certainly know more by the end of the Courtine human trials with the G-implant called the e-Dura, along with the transcutaneous and subcutaneous trials with NeuroRecovery Tech. For now, this is in research mode so there's nothing for the FDA to fast track yet. It has to at least make it to a clinical trial testing level.
                              Last edited by GRAMMY; 05-20-2015, 11:20 AM.
                              http://spinalcordresearchandadvocacy.wordpress.com/

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