It took me a little time to get back to Part II as I've been waiting on some information. It hasn't all arrived yet, but I figure I'll get down what information I can now.
Sine it's been a few weeks I'll make a short round up of Part I...
- Epidural stimulation trials on standing and stepping at the University of Louisville, supported by the Christopher & Donna Reeve Foundation (CDRF), receive new press attention after the lead researcher Susan Harkema published a paper with her results.
- But more importantly, already as early as October 2014 (and probably before that too), the CDRF website reported that, "Even more surprisingly, all four participants experienced significant improvements in autonomic functions, including bladder, bowel and sexual function, as well as temperature regulation."
- After this I contacted some folks at the National Institute of Biomedical Imaging and Engineering (NIH) who explained to me that they had put together a consortium back in 2015 of doctors, researchers, scientists with "the therapeutic goal is improving key autonomic functions - bladder, bowel, and sexual - effectively and safely".
- This got me thinking even more about the return of BBS that was already reported so I contacted the lab in Louisville to see if they would be doing a proper study of BBS from now on. Great news is that BBS will be part of the ongoing study.
First of all, I want to admit that I am cynical about the role of epidural stimulation in regards to any real cure for paralysis. I don't think that the current return of some motor function would do much to really improve quality of life.
Why? Well, as reported, after many years, I believe it was 2011, one of the subjects is able to stand up. Not step, but stand up. So I just don't see how we can expect wide scale use when six years of locomotor training has to go into it just for the end result to be standing up.
BUT...
I have to admit that I am excited about the report mentioned above, "Even more surprisingly, all four participants experienced significant improvements in autonomic functions, including bladder, bowel and sexual function, as well as temperature regulation."
I tell you, this echoes in my brain.
Which one of us paralysed folks wouldn't want the return of these functions? In fact, many who I've spoken to don't have a lot of faith in epidural stimulation getting us walking again, but all hope about its effects on BBS.
And this is where I started looking for the more info like it says in the title. This led to Dr. Giles Brindley who made his own BBS machine (sacral anterior root stimulator) back in the late 60s with succesful trials in the early 80s. A 1995 paper (fourteen years before I was paralysed) "Sacral anterior root stimulation for bladder control in patients with a complete lesion of the spinal cord" in the European Journal of Neurosurgery stated:
And there are more and more studies. You don't need me to google for you. Type it in...
Actually, this has been on the market since 1982. their web site states that:
It's all there. I've actually written to some doctor biographers of Dr. Bridley and will report back with some more information once I get it.
Before I go to far down this road, I'm going to stop. Trust me, or don't and google it yourself, there are loads of studies and devices aimed at the neurogenic bladder and bowel which have been tested on those with spinal cord injury.
The point of this blog post was supposed to be about the CDRF funded study in Louisville.
So where do I go from here?
If we already have tested and proven electrical devices for BBS why was the "Unexpected Success Story" so surprising? The CDRF site reported that, "Even more surprisingly, all four participants experienced significant improvements in autonomic functions, including bladder, bowel and sexual function, as well as temperature regulation." (9 October 2014).
I guess my next step is an email back to the Louisville lab to ask why they were surprised. An even bigger question I have, and I will ask is this...
"While I understand that the return of some BBS function was unexpected and you had no chance to establish a baseline of the participants prior to the start of the study, why are there no concrete reports of the significant improvements mentioned on the CDRF website? I could understand if there was no reporting of BBS return, but since it has been reported many times, I don't see the reason to keep specifics secret.
"BBS return is widely rated number one with paraplegics, and just below breathing and arm function for quadraplegics, in multiple surveys and many have a lot of hope that your study will prove effective for BBS. I ask if more specific information can be given regarding the significant improvements that were made."
I'll let you all know the answer when it comes.
Why? Well, as reported, after many years, I believe it was 2011, one of the subjects is able to stand up. Not step, but stand up. So I just don't see how we can expect wide scale use when six years of locomotor training has to go into it just for the end result to be standing up.
BUT...
I have to admit that I am excited about the report mentioned above, "Even more surprisingly, all four participants experienced significant improvements in autonomic functions, including bladder, bowel and sexual function, as well as temperature regulation."
I tell you, this echoes in my brain.
Which one of us paralysed folks wouldn't want the return of these functions? In fact, many who I've spoken to don't have a lot of faith in epidural stimulation getting us walking again, but all hope about its effects on BBS.
"A Finetech-Brindley bladder controller was implanted in 17 patients with a complete lesion of the spinal cord...Our patients have now been followed-up for periods varying between 1 and 6 years. In all 17 patients, the bladder capacity has been increased; 16 patients have a residual volume of less then 30 ml, urinary tract infection is rare; 12 patients are fully continent. All male patients can achieve a full sustained erection by means of the implant and 13 patients are using the implant for bowel function."
And there are more and more studies. You don't need me to google for you. Type it in...
Actually, this has been on the market since 1982. their web site states that:
The Finetech Brindley Bladder Control System (branded as VOCARE in the US) is an active implantable medical device and is intended for restoration of bladder function after complete spinal cord injury. Secondary functions include the aiding of bowel evacuation and penile erection. Spinal cord injuries patients can benefit from this system to:-Restore bladder control; Bowel evacuation; Penile erection
It's all there. I've actually written to some doctor biographers of Dr. Bridley and will report back with some more information once I get it.
Before I go to far down this road, I'm going to stop. Trust me, or don't and google it yourself, there are loads of studies and devices aimed at the neurogenic bladder and bowel which have been tested on those with spinal cord injury.
The point of this blog post was supposed to be about the CDRF funded study in Louisville.
So where do I go from here?
If we already have tested and proven electrical devices for BBS why was the "Unexpected Success Story" so surprising? The CDRF site reported that, "Even more surprisingly, all four participants experienced significant improvements in autonomic functions, including bladder, bowel and sexual function, as well as temperature regulation." (9 October 2014).
I guess my next step is an email back to the Louisville lab to ask why they were surprised. An even bigger question I have, and I will ask is this...
"While I understand that the return of some BBS function was unexpected and you had no chance to establish a baseline of the participants prior to the start of the study, why are there no concrete reports of the significant improvements mentioned on the CDRF website? I could understand if there was no reporting of BBS return, but since it has been reported many times, I don't see the reason to keep specifics secret.
"BBS return is widely rated number one with paraplegics, and just below breathing and arm function for quadraplegics, in multiple surveys and many have a lot of hope that your study will prove effective for BBS. I ask if more specific information can be given regarding the significant improvements that were made."
I'll let you all know the answer when it comes.
this is Lunasicc42, looking forward to hearing the follow-through
ReplyDeleteMy email is ready and I'm just passing it along to some for their opinions.
DeleteYeah, I’ve heard of Finetech-Brindley but haven’t looked into it closely. But I’ve always wondered that if it’s an old and successful technology then why it’s not widely deployed.
ReplyDeleteI think one issue is that it works best with rhizotomy and many would shy away from it. There is a current clinical trial going on in America run by a Dr. Creasey that is trying with no rhizotomy. https://clinicaltrials.gov/ct2/show/NCT02978638
ReplyDeleteAlso, Medtronics makes a product called Interstim II which doesnt require rhizotomy.
But let's keep our eye on the ball. If we can ever regenerate the spinal cord, all these machines will probably be useless to us (but maybe temporarily useful to us now and maybe others even in the future).