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    #31
    Originally posted by niallel View Post

    I don't want to sound negative as it's important this comes out as soon as possible. However "easy to use" isn't going to be the case. It's not a device to take home and immediately start stimulating. Hopefully a consistent process can be defined to use it at home, but I'm not sure that's a thing at the moment.
    Once is configured, the ARC Ex should be as easy to use as any TENS unit. You place the electrodes, turn on the stim, and select the propper program. In fact, is basically a TENS unit with some changes in the electric wave (primarly higher carrier frecuency), theres no more complexity than that.
    Last edited by LethalSpoon; 26 Aug 2021, 1:50 PM.
    HOC NON PEREO HABEBO FORTIOR ME

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      #32
      Originally posted by LethalSpoon View Post

      Once is configured, the ARC Ex should be as easy to use as any TENS unit. You place the electrodes, turn on the stim, and select the propper program. In fact, is basically a TENS unit with some changes in the electric wave (primarly higher carrier frecuency), theres no more complexity than that.
      Of course that would be the idea, but the reality is that using a tcSCS device isn't as easy to use as a TENS unit.
      The idea is that you set it at a level below the Motor Evoked Potential so you are providing a boost to the level you already have. This means the tcSCS + your ability takes your body over the level needed to make muscles fire.
      If you just set the power level of the device higher then you will fire muscles, however you will have no control over them.

      Now this sounds easy to do, however everyone has different a different MEP level that needs to be monitored, and the power needs changing based on MEP changes.
      So can this part be done easily at home? I'm not so sure that without monitoring you are going to get the best outcome.
      Maybe regular clinic visits could be combined to make this better, I don't think anyone knows yet because its all been done in the clinic for the existing trials.

      Secondly, it is something that someone else will need to help you with to put the electrodes on in the right places. This isn't easy at all by yourself. This is obviously achievable, but I don't think it's going to be so easy for the mass population to do.
      In my case it was very hard to find the right places consistently, and although not essential I had my back tattooed at each level so it was easy for someone else who didn't have to know how to find the right places to put the electrodes on.

      Depending on what someone wants to achieve maybe some of these things won't be relevant, especially when you are not trying to drive motor function.
      For example if you want to trigger voiding your bladder, then just connect it up and turn up the power - at 150mA you will start to void.

      There are so many combinations for different things, so my point is this isn't like a TENS or FES. It's not like you can just take it home, connect it up and turn it on treatment.

      Have a read of some of the papers and you will see its not so straightforward and the settings are slightly different for each person.

      As I said previously I'm not negative on this, far from it. It will be a really useful treatment.

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      • Mitchitsu
        Mitchitsu commented
        Editing a comment
        That was hugely insightful. I did not know a lot about this product but it looks promising and your description of the way it works was very helpful. Thank you.

      #33
      Maybe we are talking about two different things? Correct me if Im wrong, but I think ARC EX is based in studies like this of Dr Inanici,
      https://www.ece.uw.edu/spotlight/spinal-stimulation/
      In fact the same patient that undergo the study apears in the Onwards video playing guitar. This device is focused in hand and arm function, no bladder o bowel, and they use a TENS like unit with some modifications to stimulate specifically the dorsal roots. The key part is the carried frecuency, because is high enough to reach deep without disconfort (around 10khz).

      And in the Onwards second video, around 18 min mark, they talk specifically of approval of the unit to using it in home once rehab ends. So it appears like it will be easy enough to use.
      https://youtu.be/_s4Oa2LomWw?t=1047
      HOC NON PEREO HABEBO FORTIOR ME

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        #34
        Originally posted by LethalSpoon View Post
        Maybe we are talking about two different things? Correct me if Im wrong, but I think ARC EX is based in studies like this of Dr Inanici,
        https://www.ece.uw.edu/spotlight/spinal-stimulation/
        In fact the same patient that undergo the study apears in the Onwards video playing guitar. This device is focused in hand and arm function, no bladder o bowel, and they use a TENS like unit with some modifications to stimulate specifically the dorsal roots. The key part is the carried frecuency, because is high enough to reach deep without disconfort (around 10khz).

        And in the Onwards second video, around 18 min mark, they talk specifically of approval of the unit to using it in home once rehab ends. So it appears like it will be easy enough to use.
        https://youtu.be/_s4Oa2LomWw?t=1047
        We are talking about the same thing. It can be used for lots of different things, there are many studies on different things with transcutaneous spinal cord stimulation.

        I know the large scale trial to get regulatory approval for sales is for hand function. I'm lucky to have use of my hands so haven't tried it there - and the parameters are much better defined for this purpose and have been studied in larger trials, so hopefully home use is on the cards, and maybe once the parameters have been set in the clinic they won't need changing, or if they do you will have more appointments to work out the changes needed as time goes on.

        I do stand by the fact that the current product is not as easy to use as a TENS device. I've got experience of the device, and also of the Cosyma device - they are not so simple to use. They are simple to set the parameters and switch them on, there aren't so many of them, but getting the right settings is the challenge.
        Maybe look at it a different way, with TENS or FES you just turn them on and you get the effect. With tcSCS there is customisation needed for each person, and then there is a lot of hard work in the rehab part to get results.

        Again, I'm very positive on this technology, just be aware it's not a technology where you just turn it on and your hands start working again.

        PS. Just looked at the link you sent of the trial with Dr Inanici. Take a look at the picture at the bottom, it shows them doing the monitoring for the muscle activity using EMG. This is what I mean about the device itself not being the whole solution.
        Last edited by niallel; 28 Aug 2021, 4:53 PM.

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          #35
          Then something is missing from the picture. They want it to be easy to use, to get home use approval, they clearly design it to be very compact and simple, then suddenly it ends being harder to use than EMS, FES or TENS units, that have more programs, uses, and electrodes can be sticked in almost all the body? Doesnt make any sense to me. In the end your only goal is to stimulate dorsal roots, and the difference between individuals response is not bigger than the ones needed in FES, TENS or EMS.

          I found the pdf of the study, and they didnt make a lot of customization:
          IEEE Xplore Full-Text PDF:
          We used an electrical current waveform for transcutaneous spinal cord stimulation that was either biphasic or monophasic, 1 millisecond pulse width, 30 Hz base frequency, with a 10 kHz overlapping frequency (Fig. 1 inset). Stimulation intensity was adjusted between 0 and 120 milliamperes (mA) using a tablet computer as a programmer
          Originally posted by niallel View Post
          Again, I'm very positive on this technology, just be aware it's not a technology where you just turn it on and your hands start working again.
          I know, in fact completes like me probably don't get anything from it.
          Last edited by LethalSpoon; 28 Aug 2021, 6:37 PM.
          HOC NON PEREO HABEBO FORTIOR ME

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            #36
            Originally posted by LethalSpoon View Post
            They want it to be easy to use, to get home use approval, they clearly design it to be very compact and simple, then suddenly it ends being harder to use than EMS, FES or TENS units,
            Of course they do, and they are making further product developments to do this. But as I say it won't be as easy as EMS, FES or TENS.
            If you ask me they should be doing home trials now, then they could learn the issues from people using at home. As far as I'm aware they have only spoken to 2 people who done tcSCS at home. Me and the person I loaned my device to for a while. If they had a much larger amount of people it would definitely give more info to how it should be enhanced to remove these issues.
            Personally I think it needs EMG building into it and then suggesting the power needed based on that.
            On the other side, it is better for this to come to market as soon as possible, so maybe the next few iterations of the device will do this. When they start making money they can put more into R&D of usability.

            Maybe contrast with these devices. With the exception of pain control with TENS, how much benefit does anyone get from EMS or FES for the effort put in. OK, you can build muscle mass, but if you can't use the muscles then what is the point for us?
            If its harder to use than NMES then ultimately thats fine if the benefits are greater.

            Originally posted by LethalSpoon View Post
            I found the pdf of the study, and they didnt make a lot of customization:
            IEEE Xplore Full-Text PDF:
            But if you read further then you will see the monitoring that lead to customisation:
            For therapeutic stimulation, we increased the stimulation intensity in increments of 5 mA to a subthreshold level. Subthreshold stimulation intensity for each activity was adjusted based on feedback from the participant about which intensity made the task easiest. We typically observed enhanced volitional control over weak or paralyzed muscles between 40-90 mA stimulation intensities. We confirmed that stimulation parameters for each participant were not evoking direct muscle contractions using surface EMG (Delsys Trigno wireless system, Boston, MA, USA). Electrodes were placed on eight upper extremity muscles (deltoid, triceps, biceps, extensor digitorum, flexor digitorum, first dorsal interosseous, abductor pollicis brevis, and abductor digiti minimi) on each arm and hand.
            Finding that subthreshold level is the really hard part, doing that at home will be challenging (that's a polite way of saying f'kin frustratingly ridiculous), and if it changes over time then the settings (power level) will need to change.

            Originally posted by LethalSpoon View Post
            I know, in fact completes like me probably don't get anything from it.
            Don't be too quick to dismiss it. I'm AIS-A complete and I've been able to get things working that weren't working before. Not great motor returns, but returns all the same. I think due to the lack of monitoring, knowledge on my part, and persistence that I haven't had better.

            It seems obvious that if tcSCS is retraining circuits that have been spared then people who are more incomplete will have more circuits available and will get better results. But I've been annoyed in a big way that they didn't include a selection of AIS-A in the trials from the start.
            This is obviously down to researchers wanting to show better results, rather than the whole picture. But surely they should have looked at what it does to a larger selection of injuries.
            Now it seems a larger selection is being looked at and AIS-A is coming into trials more and more.

            At the end of the day, maybe look at it like I am. When there is nothing else to try, it doesn't hurt to see what can happen - only time and effort is needed.
            Last edited by niallel; 29 Aug 2021, 4:49 AM.

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              #37
              Originally posted by niallel View Post
              Finding that subthreshold level is the really hard part, doing that at home will be challenging (that's a polite way of saying f'kin frustratingly ridiculous), and if it changes over time then the settings (power level) will need to change.
              Would be great to have a platform that can be upgraded over time, like flashing a BIOS in a motherboard, to be able to adapt the device to any change you need, or improve its functions/programs. Hope they can bring something easy enough to use and affordable, so is not limited to a very small pool of people.

              Originally posted by niallel View Post
              Don't be too quick to dismiss it. I'm AIS-A complete and I've been able to get things working that weren't working before. Not great motor returns, but returns all the same. I think due to the lack of monitoring, knowledge on my part, and persistence that I haven't had better.
              Thats great, even if it's not a really meaningful return. Maybe all is not lost
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                #38
                Originally posted by LethalSpoon View Post
                Thats great, even if it's not a really meaningful return. Maybe all is not lost
                For sure, and more knowledge in the area and different protocols will help improvements further. Yury Gerasimenko is the one to follow for driving tcSCS forward in new ways. Take a look at this for example:
                https://www.frontiersin.org/articles...20.622533/full

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                  #39
                  I wish this stimulation along with extreme exercise was much more readily available either by trial or rehabilitation center.

                  It is so ridiculous how much I believe this can help me, being how well I can ambulate now.

                  I live 5 minutes away from a research center that has millions of dollars of equipment. They have everything they need. They have grants. And they've been delaying and delaying for over 2 years. I'm first on the list to get the stimulation with the treadmill. They finally called me in for all the prep. A month later they canceled...

                  It is absolutely frustrating. In fact it is grossly negligent considering how much money they received to get this equipment that is basically sitting there collecting dust.

                  And this is a top of the line University in science that has a dedicated spinal cord unit. It is nauseating.

                  I have the safety equipment and the treadmill at home. If I could just get something hooked up even by people that come to the house, I would do it in a minute.

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                    #40
                    They need to include ASIA A subjects!

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                      #41
                      Originally posted by Sparky831 View Post
                      They need to include ASIA A subjects!
                      Yes! If/when they do. I will probably go for it. Shepard Center isn't too far for me.

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                        #42
                        Originally posted by Silvio GS View Post
                        Hi guys. I have some interesting news. I’m actually in Switzerland at the moment participating in a trial from NeuroRestore collaborating with Onward. I have the privilege to work closely with Gregoire and Jocelyne and the rest of the the most skilled team members. I got two devices implanted in the thoracic and lumbar area. The main focus is to improve the blood pressure, spasticity, trunk control, breathing and coughing, AD, and other autonomic functions. There is the possibility to get some other functions improvements like bbs, legs movements or even standing. But that’s at the next stage of the trial. For the moment everything is going as well as expected and we learn more each day as I’m the first patient ever to try this kind of therapy. I can say I’m so lucky to be here and get this done already seeing that it works as was expected. Now after 2 months of very exciting works I will leave this amazing country and return to Ireland where I’ll have daily zoom session while I can also use the devices freely trying different set programs and intensities. We will keep seeing improvements more and more and then I will be coming back each month for evaluations until the end of the 6 months first stage. At the end I will come for one month and work on motor functions of sitting upright, standing and even stepping. It is entirely possible and I believe I will be at least able to stand on my own. For those that are wondering, I am C5 ASIA A, true complete.
                        So my friends keep the hopes up like I had, keep your body as fit and healthy as possible like I had. Anyone who needs any tips let me know or ad me on Instagram.
                        The therapy in trialing now will most likely be available in a couple of years because it’s safety and efficacy. Be well everybody
                        did you participate in this clinical trial?
                        https://clinicaltrials.gov/ct2/show/...&draw=2&rank=6

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                          #43
                          Does anybody know who the main contact person is for all these trials?
                          "Some people say that, the longer you go the better it gets the more you get used to it, I'm actually finding the opposite is true."

                          -Christopher Reeve on his Paralysis

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                            #44
                            Norm, it will tell you at clinicaltrials.gov who to contact.

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                              #45
                              Originally posted by Norm View Post
                              Does anybody know who the main contact person is for all these trials?
                              Good question. After NRT merged with GTX Medical to create ONWARD, David Harari, of Boston, became U.S. managing director of the new global entity. You might contact Harari through Linked-in.

                              Subsequently, after the demise of NRT, Reggie Edgerton and company went on to form SpineX (https://spinex.co/). They too, have ongoing studies building on the same technology - which originated in Reggie's lab at UCLA . The SpineX studies may be more readily accessible for U.S. participation.

                              Know Thyself

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