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Thread: Epidural Stimulation Future Trials and Commercial Planning

  1. #11
    Quote Originally Posted by tomsonite View Post
    You indeed have the right to express your opinions Paolo. My opinion is that your opinion is way off base.

    It is not a theory that epidural stimulation can return standing, voluntary movement, bowel, bladder, and sexual control, as well as temperature regulation for people with spinal cord injuries. It is a FACT. It has been demonstrated and been reproduced in more than one person. How is that a waste of time? It has gotten results!

    You yourself often say we need research that will "get people out of wheelchairs." People having the ability to stand under their own volition, even if they have to hold on to something to balance, is, quite literally, getting people out of their wheelchairs.

    Just because epidural stimulation doesn't involve regenerating the spinal cord does not mean it isn't cure research. It has gotten significantly more return of function in humans with chronic and complete SCI than any other therapy in history. How you call this a waste of time and money is beyond me.

    My prediction is that this could be a very significant part of what will be a cure. No one therapy or method will be a cure all to SCI.
    I am in favor of going forward with this because that is the only way to findout how much it really works.
    I just believe that in the end it will be a flop, so I wouldn't put my money in it while at the moment most people would and some do.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  2. #12
    Has anyone considered the implications of using this along with a regererative medicine that wise is working. Could be huge.

  3. #13
    Quote Originally Posted by Sebastiang View Post
    Has anyone considered the implications of using this along with a regererative medicine that wise is working. Could be huge.
    It's not stem cells, but he is combining with chondroitinase. It's funded by Spinal Research, same that funds the trial whit chase on dogs in Iowa.

    http://www.spinal-research.org/2012/...ndroitinase-3/
    Debating on CareCure is like participating in the special-olympics. You may win, but you're still disabled.

  4. #14
    Quote Originally Posted by paolocipolla View Post
    I am in favor of going forward with this because that is the only way to findout how much it really works.
    I just believe that in the end it will be a flop, so I wouldn't put my money in it while at the moment most people would and some do.

    Paolo
    Paolo, you posted the article by Douglas Fields again about the "young researcher" who did this work in rats in the 80's on his own as a grad student. Here is a direct quote from that article:

    "Several weeks later when he examined the nerves carefully with an electron microscope, the results were striking. There was little if any nerve regeneration in the rats in which the stimulator had been disabled, but the nerves in rats that had been stimulated with the device showed remarkable healing. Not only had the nerve fibers regenerated, new blood vessels had formed, infusing the tissue with nutrients, and the coating of electrical insulation (myelin) had re-formed around the nerve fibers. "

    Does that sound like a flop to you? You don't want this research to take focus away from "real" cure research involving regenerative therapies. Well according to the unpublished animal research of Douglas Fields and the published animal research of Gregoire Courtine, epidural stimulation IS a regenerative therapy. And while in humans, we have not actually seen (or yet looked for) true regeneration as a result of epi stim, the fact that bowel, bladder, and sexual function as well as temperature regulation have permanently returned suggests that regeneration may have occurred.

    Epidural stim alone is not a cure in and of itself. But as I and many others have said, it could be used in conjunction with other regenerative therapies to maybe bring about significant returns of function.

    The fact that you predict it will be a flop truly, truly blows my mind Paolo. It is already a massive success. It has already shown to improve the quality of life for most people with SCIs way beyond what any current therapy can do.

  5. #15
    Quote Originally Posted by void View Post
    It's not stem cells, but he is combining with chondroitinase. It's funded by Spinal Research, same that funds the trial whit chase on dogs in Iowa.

    http://www.spinal-research.org/2012/...ndroitinase-3/
    There you go. Using more than one method as part of a combinatory approach. This is why one therapy alone cannot be dismissed, we have to research everything that shows promise further because it will be multiple therapies given in multiple stages that will cure SCI.

  6. #16
    Quote Originally Posted by #LHB# View Post
    GRAMMY, What about quads? Does this device have any promise for hand and arm function?
    The trials are linked here for the transcutaneous (non-invasive) hand and arm that will be recruiting in addition to the lower limb for the new prototype.

    http://spinalcordresearchandadvocacy...otype-for-sci/

  7. #17
    Quote Originally Posted by tomsonite View Post
    There you go. Using more than one method as part of a combinatory approach. This is why one therapy alone cannot be dismissed, we have to research everything that shows promise further because it will be multiple therapies given in multiple stages that will cure SCI.
    Actually, the same team is working with electrical stimulation, transplantation of OEC and using quipazine (pharmaceutical) in combinational rodent studies.

    DESCRIPTION (provided by applicant): Our two recent studies on the potential of olfactory ensheathing glial cell (OEC) transplantation provide conclusive evidence of functional re-connectivity and sensorimotor recovery in adult rats after a complete spinal cord transection. Based on these findings, the axon regeneration induced by OEC treatment facilitated some desired sensorimotor functions, but suppressed others. This proposal asks if the OEC effect on hindlimb motor function can be enhanced in both magnitude and specificity with different activity- based interventions. The central hypothesis is that the regenerative effects of OEC can be enhanced by activity-dependent mechanisms, such as epidural spinal cord stimulation (ES) combined with a serotonergic agonist, and training for a motor task (climbing or step training). Much work from our laboratory has focused on the effects of chronic, low intensity ES in completely paralyzed mammals, and although the mechanism is still unclear, ES plus the serotonergic agonist quipazine activates the lumbosacral neural circuitry and greatly enhances locomotion in spinal rats. Our recent work in a human model shows that ES, when combined with motor training, can trigger functional regenerative events and recovery of independent standing and volitional control of lower limb movements. To further develop strategies to amplify the magnitude of the OEC-mediated effects observed previously, two Specific Aims are proposed using fibroblast- and OEC-treated complete spinal cord transected rats and extensive electrophysiological, anatomical, and functional assessments.

    Specific Aim 1 will determine whether the regenerative effects of OEC transplantation are greater than those of the fibroblast controls, and if ES and quipazine (to modulate spinal excitability) or a "voluntarily" initiated training of a climbing task (to engage supraspinal pathways) will promote OEC-facilitated axonal regeneration and sensorimotor recovery.

    Specific Aim 2 asks if the regenerative effects of OEC transplantation are more robust when enhanced by the combined treatments of ES and voluntary climb training or the treatments of ES and treadmill step training. We anticipate that both the magnitude and specificity of the regeneration initiated by OEC transplantation will be most enhanced by ES and climb training, and that these interventions will stimulate the supraspinal and propriospinal networks to improve performance of selected sensorimotor tasks. Innovative features of these studies include the sophisticated measurements of evoked potentials in awake behaving spinal rats, a comprehensive battery of functional evaluation tools, and tracing experiments to detect regeneration of supraspinal and propriospinal neurons.

    The significance of these studies is to determine the extent to which both the amount of axon regeneration across the transection site and the specificity of the established re-connections can be enhanced by activity-dependent mechanisms. Ultimately, such mechanisms may be among the best candidates to enhance the functional benefits derived from OEC transplantation in completely paralyzed SCI patients.

    http://projectreporter.nih.gov/proje...&icde=19539541
    Last edited by GRAMMY; 03-05-2014 at 06:39 PM.

  8. #18
    Quote Originally Posted by tomsonite View Post
    Paolo, you posted the article by Douglas Fields again about the "young researcher" who did this work in rats in the 80's on his own as a grad student. Here is a direct quote from that article:

    "Several weeks later when he examined the nerves carefully with an electron microscope, the results were striking. There was little if any nerve regeneration in the rats in which the stimulator had been disabled, but the nerves in rats that had been stimulated with the device showed remarkable healing. Not only had the nerve fibers regenerated, new blood vessels had formed, infusing the tissue with nutrients, and the coating of electrical insulation (myelin) had re-formed around the nerve fibers. "

    Does that sound like a flop to you? You don't want this research to take focus away from "real" cure research involving regenerative therapies. Well according to the unpublished animal research of Douglas Fields and the published animal research of Gregoire Courtine, epidural stimulation IS a regenerative therapy. And while in humans, we have not actually seen (or yet looked for) true regeneration as a result of epi stim, the fact that bowel, bladder, and sexual function as well as temperature regulation have permanently returned suggests that regeneration may have occurred.

    Epidural stim alone is not a cure in and of itself. But as I and many others have said, it could be used in conjunction with other regenerative therapies to maybe bring about significant returns of function.

    The fact that you predict it will be a flop truly, truly blows my mind Paolo. It is already a massive success. It has already shown to improve the quality of life for most people with SCIs way beyond what any current therapy can do.
    Tom,

    here I am just trying to manage expectations as too many disappontments have happened in the past.
    This "stuff" is very old and if it could really work it would have been done already, I believe.
    If you add ch'ase to the game you may see a better recovery, but IMO it is unlikely to see a super recovery as some people may expect. It may also result in worse recovery at this stage.
    In my opinion, this could be also like holding a part of the puzzle in your hand and keep looking for the same part around. We know E-stim stuff is going to help somehow once we will find the other parts of the puzzle (regeneration), but we need to find these parts first to understand how to best use E-stim approaches.

    We probably have also a different definition of "massive success".

    For ex. do you think Lokomat & FES have been a massive success? I don't think so, I just think they have been a small step forward.

    Paolo

    P.S. I think bowel, bladder, and sexual function recovery are just anedoctal repports, am I missing something?
    Last edited by paolocipolla; 03-06-2014 at 09:34 PM.
    In God we trust; all others bring data. - Edwards Deming

  9. #19
    Quote Originally Posted by paolocipolla View Post
    Tom,

    here I am just trying to manage expectations as too many disappontments have happened in the past.
    This "stuff" is very old and if it could really work it would have been done already, I believe.
    If you add ch'ase to the game you may see a better recovery, but IMO it is unlikely to see a super recovery as some people may expect. It may also result in worse recovery at this stage.
    In my opinion, this could be also like holding a part of the puzzle in your hand and keep looking for the same part around. We know E-stim stuff is going to help somehow once we will find the other parts of the puzzle (regeneration), but we need to find these parts first to understand how to best use E-stim approaches.

    We probably have also a different definition of "massive success".

    For ex. do you think Lokomat & FES have been a massive success? I don't think so, I just think they have been a small step forward.

    Paolo

    P.S. I think bowel, bladder, and sexual function recovery are just anedoctal repports, am I missing something?
    The idea of epidural stimulation is old. So is bureaucracy that slows the progress of research. The idea that the spinal cord can't be regenerated is also old and pervasive, as is the idea that the brain controls walking and the spinal cord has nothing to do with it. This is why it hasn't been tried in humans until recently. We don't know the extent to which it really can work yet, though we already know it can do quite a lot.

    Are you saying that if you combine epidural stim with ch'ase, you believe a person's motor, sensory, and/or autonomic function will get worse? How do you come to that conclusion?

    You seem to think that regeneration and epidural stimulation are two separate things. I think that epidural stimulation brings about regeneration, or at least amplifies it. Again, animal research provides evidence for this, and so does permanent return of bb&s function (in chronic, complete humans). Epidural stimulation is worth researching further so we can optimize it as much as possible NOW, regardless of whether or not we have CNS regeneration figured out yet.

    As far as I have read, the return of bb&s function is anecdotal. But it is consistent for all four people who have been implanted so far. Again, it is something worth investigating further. It is not something that should be disregarded as a future flop.

    In the grand scheme of curing SCI, FES and the Lokomat have not been massive successes. I agree they are small steps forward...they are small pieces of the puzzle, and I think FES especially plays much more of a role in keeping people healthy than it does in recovery. Epidural stimulation has been shown to elicit muscle activity, enable voluntary standing, enable voluntary control of muscles below injury, and return bowel, bladder, sexual, and temperature regulation function in chronic, complete humans. Compared to any other therapy or method that has been tested in chronic, complete humans, epidural stimulation has been the most successful in improving function. So, I consider it a massive success. Even if epidural stimulation never allows people with SCI to progress past what we have already found, it would still allow for massive improvements in the lives of most people with SCI.

    By the logic of trying to manage expectations, we should just say everything is going to be a flop, so that way nobody ever gets their hopes up for anything. One of the problems with this way of thinking is that everyone will think everything will be a flop and a waste of money and time, and nobody will want to research anything. That is my biggest issue with your way of thinking here. You seem to want to discourage any research that won't turn SCI people into able-bodied people instantly, in one surgery or procedure. It's not going to be that simple.
    Last edited by tomsonite; 03-06-2014 at 10:40 PM.

  10. #20
    Quote Originally Posted by tomsonite View Post
    ....
    Are you saying that if you combine epidural stim with ch'ase, you believe a person's motor, sensory, and/or autonomic function will get worse? How do you come to that conclusion?
    ....
    I am just saying that adding Ch'ase to Epi-Stim you can have 3 basic results:
    1) better recovery than Epi-Stim alone
    2) same recovery
    3) worse recovery

    My prediction is that more likely there will be the same recovery, but I have no real scientific evidence on which base my prediction so I am curious to see what will come out of the combination.
    Also Epi-Stim alone will be a flop in the end as the recovery I have seen so far is very hyped as in reality it seems very modest to me.

    http://www.youtube.com/watch?v=ykUMNi172Ag

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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