The medical director of the FUS Foundation, Dr. Meakems, pointed out that it says, "not yet recruiting" which he said means no one is on duty to receive communication.
Here is what the trial contact person said.
"Dear Marc,
Thank you for your email. I understand how this may be frustrating for you and others. I sincerely apologize if any emails or phone calls have been overlooked. I have received numerous emails for this trial and I typically try to respond within a couple of days. I do not show any unanswered emails at this time and there may be an issue with our new security system blocking emails from certain domains. This is certainly no excuse and I will follow-up to see if we can get this issue resolved. As a sponsor of this trial, I am limited in what I can discuss regarding this investigational trial under regulatory guidelines. However, we are working with sites to open them for enrollment as quickly as possible. I will be updating site information on clinicaltrials.gov as soon as we have our first site open to enrollment, which is anticipated by end of this month. The treating sites will be the point of contact. While we were making every efforts to open sites by February, we did encounter delays. I can see how the anticipated start date could be misleading. I will update the website to reflect the new anticipated date.
Thank you once again Marc for your email. I sincerely apologize for the inconvenience it may have caused you and others. Please be assured that as soon as I have sites open for enrollment, their contact information will be updated immediately on the website.
Regards,
Gagan"
This guy doesn't make the decision for who is accepted, anyway. That would be made by the practitioners at each location. I am guessing the locations will be the same as those where they conducted the pallidotomy trials. If I had already pretty much decided I wanted to get in this trial, I would go ahead and send an email to whichever location is closest to you that you expect to participate in and ask to be put on the list.
If I really, really, really, wanted to get in on this trial, which I would, in part because it would save me $80,000, (proving being the early bird doesn't always get you the worm. Sometimes it gets you a huge bill,) I would contact the three most convenient locations in case one or two filled up quickly. Getting a free PTT - like winning the lottery.
Thank you for getting this information, it would be so much easier to have this done in the USA at this time as well as the cost savings. I appreciate all your help.
Sure but I have to run out right now. Either you can post it for me Or I will post it in a couple hours when I get back.
After the trial, going with the assumption that it goes well, what happens next and what is the timeline? (I normally would not assume a trial will go well but with FUS I’m hopeful that is reasonable.). Will this trial be sufficient for it to be approved for PWP or will more trials follow?
Who knows? I certainly don't. I suspect it will be enough when combined with the outcomes of pallidotomy, if the safety profile is pretty high. Plus, these are extremely expensive procedures, so it's not possible to do a trial of several hundred. It's not unrealistic that the hospitals will bill the sponsors $75,000 per.
Primary completion date January 1, 2022, study completion date January 1, 2023, then another year to digest the data. (They are already two months behind schedule.) FDA approval by 2024 would surprise me, but maybe in 2025.
Then, the issue becomes how long will Medicare stall their coverage.
FUS thalamotomy was fast-tracked as it piggybacked on the ET trials. The investigators for FUS pallidotomy had hoped to fast-track approval based on small numbers of subjects but that did not happen as the results have not been what they hoped for (at least this was case as of 2018).
I don’t have any official information. I’m going based on conversations I had with the principal investigator of my trial. The results were not what they had hoped for which is why the trial was expanded.
Why do American citizens willingly accept huge price tags for medical procedures? What are the elements that make this cost $75K? Will hospitals not participate in research/trials on a not for profit cost basis ?
I participated in a FUS pallidotomy clinical trial and they were accidentally sending me the bills. The bill for the anesthesiologist was $8000 - even though everyone knew there could be no use for him because I got the sham procedure. He stood around talking with the other doctors for three hours.
You might have seen this BBC story from 2016 about treating a man with tremors. Nice video footage as well. The article mentions a price of £12500 as well!bbc.co.uk/news/health-38157770
I hadn't seen it. I don't know if that fee was billed to the UK government or to the patient? I'm not sure comparing medical procedures in the UK to US is apples to apples -- because if the (US) anesthesiologist's fee was billed at one half of the £12,500, they couldn't have gotten everything else squeezed in the remaining half.
I am not sure that is an unreasonable fee. Owning all the equipment and doing all the preop test/evaluations in-house is too expensive for one doctor's office , so they have to subcontract everything - the overnight stay in a nearby hospital, at least three MRIs, physical exam, blood panel, EEG, two neurosurgeons and five support staff, etc.
I just looked it up & the average salary for a neurosurgeon in the US is $800,000 per year. I think that's probably low.
The USA is far more expensive than Europe. A Swiss private clinic is premium pricing for Europe. Neurologists here in France bill 60 euros for a 20 minute consultation. I pay about 25‰ of that and state health insurance pays the rest. (actually, if the treatment or procedure is directly related to my parkinson's disease the state picks up the whole tab.) Last MRI scan of my head, including 2 large film plates, 400 images on a dvd rom with the reader software on it, and a discussion with the radiologist cost me 23 euros (pre-diagnosis with PD)
EEG (actually an ECG) cost me 35 euros, inclusive a "free" 20 minutes cardiologist consultation.
Full blood report, results posted on line same day costs me 11 euros
There is no socialized medicine in the US. Unless you have insurance, you are screwed. Attending medical school or any other higher education establishment comes with a very, very steep price. Upon graduation, graduates have to pay their huge bank loans, and they pass that on to their patients. That is why medicine is very expensive in the US.
Even during emergencies, before your are admitted, you have to provide insurance information or any other proof that you can pay in advance.
I agree with y our timeline estimate MB Anderson - it seems reasonable that there would be approval in 2025 if the results are positive for PwP.
Thank you. 2025...we shall see. I sure hope so. I don’t want to derail the subject but I’m curious if you have been following the Kyoto stem cell trial and other stem cell trials being planned? CPT posted a YT video of the neuroscientist from Kyoto.
The Kyoto trial is scheduled to end in 2022 and the neuroscientist said he wants to have results in 2023. CPT YouTube video of the neuroscientist said this.
Parkinson’s.org says focused ultrasound is already approved for PD. I thought that approval would not happen until after this trial.
Lenam recently wrote a post explaining that focused ultrasound is equivalent to scalpel. Without a specific surgery/procedure it’s just the tool. FUS thalamotomy is the procedure that is approved as a treatment in the US. The trial is for PTT which is a different procedure currently only available in Switzerland. If you explore the FUS foundation website you will find that FUS is used to treat a multitude of diseases, not only PD.
do the math. do even know if any these teams have done a successful FUSPTT? You don't? Sometimes I wonder.
I always wanted to jump out of an airplane without a parachute to find out what it would feel like when I hit the ground. Is there a clinical trial for that?
I'm hoping some of them have enough humility to train with people who have done PTT. I assume some are too arrogant to need actual training.
However, I suspect every location will be those with experience doing FUS for essential tremor, pallidotomies, and thalamotomies.
Yours is an important consideration. If I were contemplating FUS PTT as a part of this clinical trial, I would find out which locations have the most experience. I believe Seattle and UVA at Charlottesville were early adapters. I would also go through the screening procedure with 3 locations simultaneously so that when I got to the face-to-face interview with the neurosurgeon, I could ask him or her how many they had done. (I would advise against asking that in an email because that might end their consideration.)
If they have done a lot of the other procedures, among other things I know nothing about, the difference here will be the target location and the size of the target, which I'm given to believe is smaller. The temperature range is probably different, too.
I discussed this with the doctor who did the sham pallidotomy on me and he said the difference is the target in the US is more conservative than that in Switzerland, i.e., which I take to mean it is a larger area.
I know you do not consider this brain surgery. You reprimanded me for using the term. But when a brain surgeon rearranges the function and structure in your brain, it's brain surgery, regardless of the instrument used and people should use at least as much care as they do when buying fruit at the grocery store.
My understanding from my last surgery is PTT is a more exact target as you are 100% destroying a tract of nerves instead of part of the thalamus or palladium . So if you do it well it is safer, but not done well is way more dangerous as you do not want to hit neighboring structures. Definitely a brain surgery just done safer than with a scalpel. Personally I won't want to be first for a surgeon.
I remember you used to disparage the Swiss clinic, but now it seems you switched, so, therefore, you are un-banned. You are free once again to shoot from the hip.
you took my comment out of context. go back and re-read my comments. I was comparing a "known entity" which has some credible results in a non-random case study to one that is totally unknown, as in "who knows what? where? when? who?"
the ct will use this system, not the Swiss system.
The ExAblate® Model 4000 Type 1.0 (“ExAblate”, “ExAblate Neuro” or “the system”) is designed for the non-invasive ablation of brain tissue for the treatment of medication-refractory tremor in patients with Essential Tremor (ET), is a transcranial, magnetic resonance, image guided focused ultrasound (MRgFUS) system. The treatment goal of the ExAblate Neuro system is to accurately guide the focus of the ultrasound energy to the target region. Focused ultrasound energy is then repeatedly transmitted to the target until the desired outcome is achieved. Targeting is accomplished using magnetic resonance (MR) images taken during the treatment.
I'm not so sure you're right about this, Dr. Crayola, but I'll find out for you.
SoniModul website says they use InSighTec's ExAblate Neuro TcMRgFUS brain system. Maybe they left off "model 4000 type 1.0." The system you identify is also InSighTec's.
Everything else you said, that is, your description of what it does is exactly the same.
The “ExAblate® Model 4000 Type 1.0” is the only device used worldwide for incisionless neurological ultrasound treatments. There is no unique “Swiss system“. Although as noted elsewhere, Dr. Jeanmonod helped in the development of this tool based on the Model 2000 which I believe is used for uterine fibroids and other procedures away from the brain..
it isn't the machine, it is the method they use for PD. read their 2 case studies. it is unique. send me another FUS PTT for PD case study that uses their method. good luck finding one except a much earlier swiss one in 2014 that might have. this ground has been plowed.
Your reference was clear and if there was any doubt the fact that you specifically cited the description of the device from the other trial to make your point should eliminate it. There was no mention of the PTT procedure itself and simply saying that you didn’t say what you clearly said is not helpful.
This is an important point since the Insightec device enjoys wide acceptance and an inference that the Swiss clinic is using something else is both negative and false.
As to the procedure itself (PTT) it has been the subject of numerous papers since the 1990s and even earlier in the context of being performed as an open surgical procedure (FUS was not available of course).
PTT is an established treatment and FUS has been established as a safe, dependable and accurate mechanism for delivering treatment.
As to case studies involving FUS PTT performed in other centers outside of Switzerland, please see below.
It is difficult to imagine that the FDA would be this far along without significant clinical history and experience for this procedure, particularly since approval for bilateral treatment is the goal.
I am sure you mean well, but dismissing others based on incomplete knowledge and using jargon like “this ground has been plowed” is not helpful, respectful or informative.
"It is difficult to imagine that the FDA would be this far along without significant clinical history and experience for this procedure, particularly since approval for bilateral treatment is the goal."
You are wrong. This CT has barely begun if at all. see and read previous HU posts (at least 2 threads) which discus this CT.
your citation: Unilateral pallidothalamic tractotomy for akinetic-rigid Parkinson’s disease: a prospective open-label study ... 10 participants is not a significant study by any measure.
Taira's study = 2 citations from you = 1 insignificant study .... see above citation which simply repeats your first citation. (his other studies in other areas are extremely small case studies, not clinical trials)
from the swiss study... very specific as to their procedure which I have referred to several times in previous multiple posts....
"the procedures were performed in a 3T MR imaging system (GE Discovery 750, GE Healthcare, Milwaukee, WI, USA) using the ExAblate Neuro device (InSightec, Haifa, Israel). Targeting was performed using the stereotactic multiarchitectonic Morel Atlas of the Human Thalamus and Basal Ganglia (56) and its developments (28, 53). Three-dimensional stereotactic coordinates were measured on the MR images, based on the intercommisural line and the thalamo-ventricular border. The center of the PTT target was located 6.5 mm from the medial thalamic border (L 6.5), 1 mm posterior to the MCL (MCL-1) and on the intercommissural plane. Sonications had the shortest possible time and the corresponding power in order to provide a thermal dose of 240 CEM at each focal point which represents a conservative value corresponding to a 100% probability of lesion in a volume of 1.5 × 1.5 × 3.0 mm. The detailed technical description of the targeting and realization of the MRgFUS PTT using thermal dose control has been published in a separate work (53)."
As to your initial reference to the “swiss system”, It was clearly a reference to the hardware described in the other clinical trial and did not at all reference the treatment protocol. The inference was clear – which is that the Swiss clinic was using a different device. Including a description of the Swiss clinic’s treatment protocol In your subsequent posts, which nobody disputes, does not change what you originally said although it may confuse people who haven’t read the entire string.
You asked for a case study (your words, and yes, a case study is not a clinical trial) and a 10 second web search yielded one. I did not bother looking for others. There is no doubt that the PTT is not as widely used as other approaches but it is also clear that it is not unique to the Swiss clinic. Just check the Internet, not that that should be your only source.
As to the US clinical trial why don’t you call the investigators and confirm whether or not you are right? Their phone numbers are right there. I have. The recently updated trial website clearly shows that they have started recruiting and will finish initial treatment by year end. It is what it is, it is a positive development regardless of your therapeutic preferences, and it is difficult to understand why anybody would infuse a discussion regarding it with vitriol.
I honestly don’t get the relevance of much of what else you cut and pasted into the response. I will not continue this discussion, since I don’t feel like seeing another unproductive word-storm, and therefore will not respond to further posts.
"It was clearly a reference to the hardware described in the other clinical trial and did not at all reference the treatment protocol"
the swiss never did a CT...either time.
from the much smaller swiss 2nd case study....THEY USED THE SAME GE DISCOVERY 750 THEY USED IN THEIR 1ST CASE STUDY.
"All procedures were performed in a 3T MR imaging system (GE Discovery 750, GE Healthcare, Milwaukee, WI, USA) using the ExAblate Neuro device (InSightec, Haifa, Israel). A standardized bilateral PTT was performed according to previously published protocol (22, 32) "
at this time, Cornell and UM have not said if they plan on using the GE 750 with the InSightec.
the new CT: An inSightec sponsored open, non-blinded, non-random CT. Definitely hang your hat on the results. bound to be positive with their sponsorship.
In contrast to the all positive news, from Horisawa's work (above citation): "However, in our experience, patients who underwent unilateral PTT for movement disorders developed mild hypophonia and dysarthria, as well as decreased hand dexterity. Considering the fact that these complications are associated with unilateral surgery, patients who undergo bilateral ...may develop serious speech and motor disturbances"
what he is saying is that having FUS PTT is not a slam dunk...all positive experience for everyone. Be very careful because you can't reverse engineer the negatives.
your cheers are much appreciated. Good luck on your FUS journey.
For the geeks among you who like to get weeds including a little information about relative experience. From their website;
"The world première-project “High energy transcranial MR-guided focused ultrasound (TcMRgFUS) therapy in functional neurosurgery” was developed in close collaboration with InSightec, Ltd and was supported by the Swiss National Research Foundation (NCCR CO-ME), the University of Zürich, the ETH Zürich and the University Children’s Hospital Zürich. It was lead by Prof. Jeanmonod in collaboration with the MR-Center of the University Children’s hospital (Prof. E. Martin), began in September 2008, ended in June 2009, and demonstrated the feasibility, reproducibility, safety, precision and efficiency of the TcMRgFUS. The second study was supported by InSightec Ltd, Rodiag AG, Privatklinik Obach and GE Healthcare Switzerland. It took place between April 2011 and December 2012 in the Center for Ultrasound Functional Neurosurgery in Solothurn and demonstrated a 0.5 mm mean targeting acuracy of the ExAblate Neuro TcMRgFUS brain system. Patients with Neuropathic pain, Parkinson’s disease and essential tremor were treated without complications.
TcMRgFUS allows to ablate with heating, with a millimeter precision, any chosen target area in and around the thalamus without skin incision nor skull opening. This allows a suppression of all risks related to skull and brain penetration. Focused means that 1024 ultrasound waves, each of them innocuous for brain tissue, converge in the target, where sonic energy gets transformed in thermal energy in an area of only 3-4 mm diameter with sharp borders. The desired temperatures are between 53 and 60 degrees Celsius, and the obtained target temperature increase is checked every 3-4 seconds thanks to MR-thermometry."
I now have reason to believe the PTT clinical trials will be the same locations as were the pallidotomy clinical trials. I don't know if there were more than eight locations for the pallidotomy clinical trials. If there were, then it won't be a perfect match up.
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Attending medical school or any other higher education establishment comes with a very, very steep price. Upon graduation, graduates have to pay their huge bank loans, and they pass that on to their patients. That is why medicine is very expensive in the US.
Inosine, Israpidine, NAC, Glutathione clinical trials - Love to hear from those who have experience with these.
