Re: the FUS PTT Trial. I complained to... - Cure Parkinson's

Cure Parkinson's

18,783 members19,392 posts

Re: the FUS PTT Trial. I complained to them as to why people have not been getting replies and here is their answer.

MBAnderson
MBAnderson

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.

Life is generally first-come first-serve.

clinicaltrials.gov/ct2/show...

43 Replies

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.

Are you willing to post this in the facebook group also Marc? Thanks!

MBAnderson
MBAnderson in reply to lenamm

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).

What were the results?

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.

Buckholt
Buckholt in reply to MBAnderson

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 ?

MBAnderson
MBAnderson in reply to Buckholt

You pay their fee or you don't get the service.

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.

Buckholt
Buckholt in reply to MBAnderson

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

MBAnderson
MBAnderson in reply to Buckholt

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.

Juliegrace
Juliegrace in reply to Buckholt

The cost of the PTT procedure in Switzerland is $35,000.00 CHf per side so it’s not just in the US.

Julie,

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.

I’m not saying it’s unreasonable. My point was the high cost is not only in the US.

Oh. True.

Despe
Despe in reply to Buckholt

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.

Canddy
Canddy in reply to MBAnderson

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.

I haven't. Are they getting pretty close?

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.

Please tell me what PTT stands for.

Canddy
Canddy in reply to cclemonade

Pallidothalamic Tract (PTT)

Resano
Resano in reply to Canddy

Tractotomy

I see that the clinicaltrials.gov website has been updated April 6, 2021. The study start date is listed as 01 May 2021.

I wouldn't lose any sleep over this delay or the CT. I would stick with the Swiss team for now. this CT is a crap shoot.

Why do you say it's a crap shoot?

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?

Dear Dr. Crayola,

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.

I wouldn't let TV Dr. OZ do it.

lenamm
lenamm in reply to MBAnderson

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?"

OK, but I thought you would be joyous re being un-banned.

un-banned from what?

@sharoncrayn, of all people, you must know that the above latest response was a joke 🤔😂😀

tongue-in cheek

Thank you for the information.Unfortunately for me, a pacemaker is exclusionary.

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.

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."

sonimodul.ch/the-concept-be...

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.