Let me assist here if I may. Epidural stimulation is not a biological cure. We're not there yet. However, these results do point the way to one method that could potentially be used for some recovery. Once the stimulator device has gone through human clinical trials and receives FDA medical device approval it could probably be sold worldwide. The stimulator used in these proof of concept human studies in an IRB at Louisville was a Medtronic 16 electrode pain device already approved by the FDA. However, the drawback to it is that it only stimulates one leg at a time. Another company is building a 27 electrode sophisticated device that will function much better and give the appropriate signals when needed. They're currently seeking financing and getting ready for transcutaneous trials. This is all very young research and development. It always takes much longer to get through the processes than we'd imagine so a guess of 5 years is a bit too aggressive in my opinion. They do have exciting results and a path forward but we have to be realistic about what it is and how long before it's made available to everyone. For the spinal cord injury field being so small, we have had some significant progress in the field over the past few years. I think it's a sign of better things to come.
Thats a fair comment grammy and im pleased you have clarified...so thankyou... .
I guess research also needs to now focus on why the nerves were stimulated to send a signal...there was some suggestion that the spinal cord may have its own 'brain'. Of course not a brain as we understand but im sure this is one area that needs to be looked at...if my understanding is correct.
At the end of the day this is a stimulator and as you say, it is not a biological cure...now that would be something!
So, as far as nerve regeneration goes...this is not what we are talking about.
Correct Lara. This is proof in concept that the spine can and does operate separate from the brain. Historically, everyone thought the brain controlled everything. Recovery is probably not from regenerated nerves per se, but the spinal cord is smart enough to rewire itself and utilize different pathways. The spinal cord is very smart.
This is great news, i read this somewhere else too. I just hope it doesent take too long though
They're hoping to start clinical trials on the transcutaneous model later this year and have it on the market in 2-1/2 years. I think those timelines are much too optimistic for gathering Series A funding and getting FDA device approval, but that doesn't mean we can't hope for it! Other companies have stimulators and devices approved that are similar, so maybe they won't have such a tough road to hoe.
They have the funds now to enroll eight more patients. Four of them will be the same as the first four as closely as possible (age, time since injury, etc.). The other four will be tested for response to epidural stimulation on cardio function. This comes from one of the first four patients, Andrew Maes, that had blood pressure issues related to autonomic dysreflexia (AD). When the stim was on his blood pressure normalized. If this cardio application can be more widely demonstrated, that’s going to be a much clearer path to the clinic than voluntary movement alone.
Getting a device approved and covered by insurance won’t be easy. More than eight more patients will have to be tested. Since the research group knows the Medtronic device they are now implanting is very suboptimal, there are efforts underway to create and market new stimulation devices, primarily by a team from UCLA (headed by Reggie Edgerton), Cal Tech and the University of Louisville. A California company, NeuroRecovery Technologies, has obtained the rights to the intellectual property from the three universities.
Wow nothing is simple grammy.....time, money and complexities..
Maybe this will go the way forward that stem cell treatment did where individuals will have to privately fund their own device and aftercare.
Here in the UK when Baclofen pumps were fitted and re fitted it was all done free..i know its off thread in a way, but out of interest, can anyone answer if insurance companies had to approve this device in their respective countries?
They have the funds now to enroll eight more patients. Four of them will be the same as the first four as closely as possible (age, time since injury, etc.).
They already have my application and my age, injury, etc is very very similar to a patient they've already had!
They have the funds now to enroll eight more patients. Four of them will be the same as the first four as closely as possible (age, time since injury, etc.).
They already have my application and my age, injury, etc is very very similar to a patient they've already had!
Even if you're not selected from the hundreds of applications for the 16 electrode, we can always hope you'd be selected for the upcoming 27 electrode but it would take a separate application since it's the technology group that will be running that trial.
I truly hope you are successful DJ..if not this time, then the next time.
Im sure all applications deserve the opportunity but i admire your determination and positive attitude and know what the opportunity would mean to not only you but your family too.