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Baclofen pump disqualifies us in stim trials?

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    Baclofen pump disqualifies us in stim trials?

    Does anyone know whether we’re only disqualified from trials or have there been actual problems when the same person has both a baclofen pump as well as an external or internal stim device?

    I just looked into volunteering for SpineX study but I’m thinking I’m exclusion #8.

    #2
    You would have to talk directly to the investigators for the study. Every study has different exclusion and inclusion criteria, and these are often required specifically by the FDA or other approving bodies for the study. (KLD)
    The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.

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      #3
      sheri...can you please drop the link that shows all the inclusion/exclusion criteria
      "That's not smog! It's SMUG!! " - randy marsh, southpark

      "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


      2010 SCINet Clinical Trial Support Squad Member
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        #4
        https://clinicaltrials.gov/ct2/show/...&draw=2&rank=2

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          #5
          Had gotten kinda psyched for this but I’m thinking exclusion #8 will be a problem. I’m definitely confused about SpineX now in that I thought they were substantially closer to being commercially available. Watched the Reeve Nurse Linda interview a couple weeks ago and thought they said 2023 but it looks like their studies are just starting. I have an email in to them.

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            #6
            Is the SCONE device something you would use in place of catheterizing? Is the idea that you use it whenever you need to empty the bladder? Or is the idea that it trains your spinal cord to remember those connections you once had to help return you to a more normal state, eventually not needing the device?

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              #7
              I actually don’t cath. Based on the trial write-up, it looks like they’re trying to demonstrate any improvement in any neurogenic bladder symptoms.

              In the Reeve interview, I remember them mentioning they’d be looking for a participant to become aware of when the bladder is full so they could cath as needed rather than by a clock.

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              • Barrington314mx
                Barrington314mx commented
                Editing a comment
                So I've been injured for I guess about 12 years now. I'd say for the first 5 - 6 years I was cathing by the clock. I also had accidents all the time. Then something switched. Not sure what but I was able to start cathing only when I felt like I needed to. And accidents stopped. I haven't had an accident in probably 6 years. So that part of it is obviously very nice, but I don't cath any less. And in-fact, I probably use more now. So if there goal was to lessen the times someone needs to cath, I'm not sure that is going to be achieved.

              • Sheri
                Sheri commented
                Editing a comment
                From the sound of it, tho what do I know, they’re trying to see whether their stim will actually simulate any increase in signal. Maybe they could then tweak things to obtain more useful functional outcomes.

                Barrington, that’s wild you say that about your weird shift in sensation. Obviously the ability to heal is there if only we could better capture it. I had one largely unusable leg for about twelve years but when my other leg deteriorated, my dead leg came back for a while!

              #8
              This is the Reeve nurse’s interview with them:

              https://youtu.be/ulGTq3lFoAw

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                #9
                Can't believe it took them so long to start trials!

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                  #10
                  Exactly! Toward the end of the Reeve talk they just did, he said they’d be available next year for neurogenic bladder. So we may still be many years out for other functional stuff?

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                    #11
                    Ok, I finally heard back from SpineX (external stim device) and this is what they said:
                    ”Thanks for reaching out. It prevents you from participating in the ongoing studies. Once it is commercially available, it will depend on your prescribing physician.”
                    I also sent the same question to Onward back have not heard back.

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