Is there a patent?
Yes, we have filed a patent, "The Plantar Sensory Replacement System," in Canada and the US (US Publication #20120109013 and PCT WO/2012/055029). We have also filed a PCT with the intention of filing with that in the EU, Japan, Brazil, Australia and possibly more. This is a very broad patent (all-encompassing). We will be filing multiple, other patents under this larger "umbrella" patent as time progresses, so as to essentially establish a "picket fence" of defense surrounding the basic concept behind the projected product line.
Will it work? Do you have any papers or info that show how anyone has been able to condition or use neuroplasicity to change a behavior (especially an unconscious negative behavior)?
There is a substantial body of work supporting the idea of sensory substitution as well as the utility of pressure-offloading in managing the diabetic foot.
Does the belt produce a painful response?
One of the main focuses in the development of the back display is to minimize discomfort. We are working this year on developing the back pad in this regard. Adjustments in type of signal sent (vibrotactile versus electrotactile) and the intensity of that signal dictate whether or not discomfort or pain are felt.
Does the feedback from the insole need to be on the back?
The feedback does not need to be on the back. The beauty of neuroplasticity is how "plastic" the brain really is. Anything goes. However, we did choose the back for a number of reasons. These are: it tends not to be affected in peripheral neuropathy (hands, feet, and limbs can be, depending on the stage of the disease), it is concealed and inconspicuous (can be hidden under clothes), it has a similar two-point discrimination (sensation capability) as the foot, and there is a large "real estate" of skin available. Still, future systems may be built to display information on other parts of the body for similar feedback. The patent covers that.
Do you expect that the belt will need to be worn forever or would the patient learn to walk correctly over time?
We believe the back display would need to be worn as long as sensory substitution and the positive effects therein are desired. We like to compare this to dental freezing. As confident you are that you know your mouth, as soon as that sensation is taken away, it is very easy to do damage. Similarly, while adaptive patterns of gait may be gained using the device, we would think that as soon as the display is off, the full benefit of these would be lost. The other point is that the device provides not only assistance and feedback to support proper gait, but it also substitutes sensation. When the device is off, that component is surely gone, whether or not the beneficial gait effects last.
What does your timeline look like and what kind of testing needs to be done? Is there a prototype of some kind?
The timeline is based on the development and commercialization of two devices: the SurroSense Rx™ and the SurroGait Rx™. Orpyx® is developing patented technology, the SurroSense Rx™, and its associated product line. In general, our products use pressure sensors embedded in insoles to determine force over the bottom of the feet. This information is wirelessly transmitted to an output device, which then relays information to the user. The SurroSense Rx™ communicates with a wristwatch display to alert the user as to when they are doing damage to their feet. Development is progressing on the SurroGait Rx™, which will provide the user with real-time feedback (and “sensory substitution”) in the form of an electrotactile display on the back. With practice, the consumer will employ the phenomenon of neuroplasticity (he or she may “rewire the brain”) to interpret the stimulus felt on the back as that from the feet." We are completing development of the SurroSense Rx now™, then will be completing Calibration/POP and Human Factors studies with this between now and May. We will be developing the back display and making appropriate modifications to the insole to suit that device's purpose. We are projecting to start clinical trials with it by early 2013. It would likely be 1-1.5y from the start of the trials that that device would be commercialized.