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Focused Ultrasound for Parkinson's: A Two-Part Webinar Series by the FUS Foundation

MBAnderson profile image
82 Replies

On Tuesday, April 28, Elisa Konofagou, PhD, of Columbia University, will discuss the latest preclinical advancements using focused ultrasound for Parkinson's disease. Register now >

The following day, Nir Lipsman, MD, PhD, FRCSC, of Sunnybrook Health Sciences Centre, will highlight exciting clinical results and ongoing studies in the area. Register now >

Please note, those interested must register for each webinar.

info.fusfoundation.org/webm...

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MBAnderson
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82 Replies
bepo profile image
bepo

Thanks

pdkid profile image
pdkid

Thanks Marc!

Just for clarification, these sorts of trials have already happened over in Switzerland?

MBAnderson profile image
MBAnderson in reply topdkid

I don't know what trials have been conducted in Switzerland. I do believe they've done some at the University hospital in Zürich. I see both presenters are from clinics in the US, so maybe they're only going to cover US trials, but I would expect they will provide some data from clinical trials outside the US as well.

.

pdkid profile image
pdkid in reply toMBAnderson

Thanks! I guess Im wondering why they are 7 years ahead in Switzerland... What took so long over on this end of the pond?

MBAnderson profile image
MBAnderson in reply topdkid

Good question. As I'm sure you know, it was pioneered by the one doctor in Switzerland who had been doing neurosurgery for PD people for many years prior to FUS. I used to think it was because of individual preferences of doctors, but I've since come to believe there are probably a handful of neurosurgeons in the US who would like to do it, but don't have the resources to gain FDA approval.

Apparently, for some reason I do not understand, the manufacturer, Insightec, has not applied for FDA approval for PTT in the US yet.

pdkid profile image
pdkid in reply toMBAnderson

Right, this all makes sense, thanks! Well, just in initial conversations with them now about treating my dad... We'll see *fingers crossed **

MBAnderson profile image
MBAnderson in reply topdkid

Have you gotten to the point where you've sent them videos of him and his medical records yet?

pdkid profile image
pdkid in reply toMBAnderson

We are just gathering these items now, and are supposed to tell Franziska when we are ready to send...

WinnieThePoo profile image
WinnieThePoo in reply toMBAnderson

Is the machine different from those used for MRI fus elsewhere, or just it's method of application? I thought they worked the same way but targeted slightly different parts of the brain?

MBAnderson profile image
MBAnderson in reply toWinnieThePoo

They look like any other MRI machine, but clearly they can be programmed for different protocols

MarionP profile image
MarionP in reply toMBAnderson

7 years???!!!

MBAnderson profile image
MBAnderson in reply toMarionP

what is 7 years?

MBAnderson profile image
MBAnderson in reply toMBAnderson

pdkid said 7 years.

MarionP profile image
MarionP in reply topdkid

7 years...que???

WinnieThePoo profile image
WinnieThePoo in reply toMBAnderson

One of the issues that isn't clear to me is whether dr jeanmonod has sought to train others outside his clinic his technique, and encountered resistance, or whether he chooses to keep it an exclusive private clinic treatment. The technology is reasonably widely available, if the procedure can gain authorisation and the physicians trained in the technique.

Dr jeanmonod technique is different from that being trialled and licenced elsewhere

MBAnderson profile image
MBAnderson in reply toWinnieThePoo

Richard, I do not know for certain, but I got the feeling that he feels there is/was resistance among the "powers to be." I did ask him if he's trained other doctors and he did say he has.

MBAnderson profile image
MBAnderson in reply toMBAnderson

PS. One consideration which is always present is that it undermines somebody else's financial interest. I suspect the Swiss equivalent of the FDA is less susceptible to financial influence.

Grumpy77 profile image
Grumpy77 in reply toMBAnderson

How far with your own scheduled FUS PTT? Is it the lockdown that is delaying the procedure?

If so, have you rescheduled to a specific date or is it postponed until further notice?

Edit: apologies if you have already given some updates on the question I asked in some other posts... I haven't been so regular here lately

MBAnderson profile image
MBAnderson in reply toGrumpy77

I just had the procedure last month, so I'm not even at my 1st/90 day follow-up

lenamm profile image
lenamm in reply toWinnieThePoo

He told me he would happily train anyone who wanted to learn but that there were a lack of surgeons interested. He did a trial nine years ago but it was not double blinded - everyone got the procedure.

Parkie- profile image
Parkie- in reply toMBAnderson

Marc, a slight correction if you allow:

"both presenters are from clinics in the US"

Nir Lipsman, MD, PhD, FRCSC, of Sunnybrook Health Sciences Centre = Toronto, Canada.

I remembered seeing Sunnybrook a few months ago while looking for FUS trials in Canada

MBAnderson profile image
MBAnderson in reply toParkie-

good catch

jimcaster profile image
jimcaster

Thanks, Marc! I signed up for both.

MBAnderson profile image
MBAnderson

I thought it might provide useful info for those interested in FUS

Parkie- profile image
Parkie-

Thank you for posting; I registered for both. If questions are allowed during the webinars, maybe we will find out why nobody is asking for PTT approval in North America... Reading this HU forum, there sure seems to be an interest by pwp!

MBAnderson profile image
MBAnderson in reply toParkie-

See answer below.

MBAnderson profile image
MBAnderson

Here, the chief medical officer at the FUS Foundation answers this question;

"When will FUS PTT come to the US?"

Dear Marc,

Thank you for your inquiry, and I am so glad to hear that you had the PTT and had a great outcome!

It is hard to answer your question with certainty, as there are a number of factors that come into play. Right now there are at least 3 different approaches to the movement disorders for Parkinson’s disease (PD), and it seems that the neurosurgical community is not very close to deciding which one is the best. There is the PTT in Switzerland, the subthalamic nucleus (STN), that is prominent in Spain and other areas of Europe, and the internal part of the globus pallidus (GPi) that is in an international pivotal clinical trial right now. I spoke with a US neurosurgeon about the PTT coming to the US, and was not encouraged that it will happen anytime soon.

I think that, ultimately, it will be data that will have to drive the selection of the right answer. I have worked hard to stay in touch with Dr. Jeanmonod and Gallay, as they have been productive of high quality research papers that we list in our reference section. There will be studies coming out on the STN and the GPi, that will include outcome data and side effects. This will allow a good comparison of the techniques, and then, ideally, the best technique will be adopted and used more universally. I wish I could say the timing on that, but I cannot really predict that. I believe that the STN paper should come out in 2020, and the GPi paper should come out in 2021. I believe it will be after those papers are published that the comparison and decision about optimal technique can be made.

I hope this helps a bit. I am glad to hear that you had a successful treatment! Let me know if I can help further.

Tim

Tim Meakem, MD

Chief Medical Officer

fusfoundation.org

tmeakem@fusfoundation.org

From: Marc Anderson <marcbanderson@gmail.com>

Sent: Wednesday, April 22, 2020 6:11 PM

To: communications@fusfoundation.org

Subject: Question for webinar 4/28

When, if ever, will the FUS PTT procedure that is done at the SoniModul clinic in Solothurn, Switzerland be available in the US?

Thank you.

Marc Anderson

PS.

I had the PTT procedure done March 11. Am very happy with the outcome.

Parkie- profile image
Parkie- in reply toMBAnderson

Thank you so much for this. So, not soon will we have the opportunity around here...

However, we might just be surprised with the trials results in US and Canada. Maybe the results will be as good as PTT and maybe with time, they will offer procedure on both sides. Lots of maybe's tho...

lenamm profile image
lenamm in reply toMBAnderson

Marc - can you post this in the facebook FUS PD group?

MBAnderson profile image
MBAnderson in reply tolenamm

sure

Lana666 profile image
Lana666 in reply toMBAnderson

Thank you Marc for getting answer to the question many of us were trying to figure out. Disappointing and frustrating. I wonder if Fox foundation can look into it. Stanford is one of the site for an international trial running FUS PTT not just for tremor indication, seems like no interested parties in US so far to evaluate this procedure. More and more indications recently especially with covid19 situation that our advancements in science and medicine are overstated. From what I heard about Stanford approach their target is slightly different and larger than in Dr. J cases. My appointment with a surgeon was canceled, hope to be able to reschedule and at least get some additional info even if recruiting gets closed. I found a paper from this Stanford surgeon with similar prediction as I read from one of your post that FUS surgeries should became a widely accepted procedure for complementary PD management.

O well, when it will happen? If only we can clone Dr J.

MBAnderson profile image
MBAnderson in reply toLana666

As per Dr. Meakem, it seems like it is a decision to be made by individual doctors, i.e., it'll come to the US when some doctor and his/her hospital decide they want to get into doing it.

Parkie- profile image
Parkie- in reply toLana666

Hi Lana

"Stanford is one of the site for an international trial running FUS PTT not just for tremor indication" That’s very interesting. Do you have a link for info on this trial?

Was your appointement with the surgeon for this trial?

Thanks

Lana666 profile image
Lana666 in reply toParkie-

Hi Parkie,

It's a Global Multicenter Pivotal Focused Ultrasound Trial for Parkinson’s Disease run by InSightec a manufacturer of a FUS unit with the purpose:

Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.

Here is a link:

clinicaltrials.gov/ct2/show...

They have number of East coast and other US sites and few international locations.

I just rescheduled a consult meeting with a Stanford surgeon. Not sure if it's an official screening appointment, cause it was scheduled based on the referral from my neurologist and not through a study coordinator. Still they want me to do a Cat Scan first. Then I spoke with a study coordinator after stay at home policy was implemented she told me that they officially reached their enrollment goals in December 2019, but due to a continuing interest the sponsor (InSightec) suggested to continue enrollment through the March of this year. I believe I was the last or one of the last scheduled for the screening. The screening was canceled and at that time the coordinator had no idea of InSightec further intention.

So, my appointment could be a pure consult, but due to CAT Scan requirement I am guessing that further development may be an option. I can post an update if there is an interest and if I have something worth saying :)

MBAnderson profile image
MBAnderson in reply toLana666

Nicole,

This is the same clinical trial I signed up for where I got the sham procedure in Columbus Ohio. Are you thinking is the same as the PTT in Solothurn?

Marc

lenamm profile image
lenamm in reply toLana666

PTT and pallidotomy are two different targets. One does not equal the other. The only current PTT trial is in Japan and only open to Japanese citizens.

Parkie- profile image
Parkie- in reply toLana666

Hi Lana

Thank you for the link. I looked into this Canada trial last year but decided on Sonimodul (awaiting September appointement).

"Stanford is one of the site for an international trial running FUS PTT not just for tremor indication"

The trial you linked is for "Unilateral Lesioning of the Globus Pallidum"

not "PTT" (pallidothalamic tractotomy).

I wish you the very best. Please keep us posted if you do get the procedure!

Lana666 profile image
Lana666 in reply toParkie-

Hi Parkie,

Actually I am also compiling a package to submit to Sonimodul. But I am in a Stanford neighborhood and don't know the output of my submission; in any case this consult should be beneficial. What's the difference between the two? I thought they both do lesions in globus pallidium. Hope to get more infos from the seminars next week. Also. I understand that a purpose of new study is to evaluate performance of new generation of the MRI unit, don't know if they change other parameters of the pallidotomy. Stanford surgeon has been performing FUS for essential tremor as well as DBS, it's good to be evaluated by an experienced neurosurgeon.

It looks we have similar forms with you: akinetic/rigid with dystonia, which became biphasial and dose dependent. If you don't mind I pm you. Thanks

Parkie- profile image
Parkie- in reply toLana666

Hi Lana

It's good that you are investigating both avenues to see what's best for you.

Dr J's procedure is an interruption of the pallido-thalamic pathway without touching the thalamus. I can't explain the difference between both sites. Jacksmar wrote a post after having an FUS surgery in a private clinic in Florida. Although he was tremor dominant, he said he got great relief from stiffness and pain. He referred a member to Stanford who was asking where it's available:

"Bianhua

I wonder if this procedure is being done in San Fco. CA

Report

jacksmar

jacksmarBianhua

3 months ago

Stanford University Medical Center

Palo Alto, CA

450 Serra Mall, Stanford, CA 94305

location tremor@stanfordhealthcare.org

location 650-721-4936

Radiologist

Pejman Ghanouni, MD

Neurosurgeon

Casey Halpern, MD

Neurosurgeon

Jaimie Henderson, MD

Patient Coordinator

Erika Lim, RN"

Yes you can private message me, but if other non tremor dominant pwp can beneficiate from our conversation, I think it's best to post. There's not that much help for us, so the more information out there, the better!

Lana666 profile image
Lana666 in reply toParkie-

Thank you Nicole.

MBAnderson profile image
MBAnderson in reply toLana666

Here Dr. Meakem answers that question. (The email thread starts at the bottom.)

From: Tim Meakem [mailto:tmeakem@fusfoundation.org]

Sent: Monday, June 10, 2019 7:14 PM

To: Marc Anderson <marcbanderson@gmail.com>

Subject: RE: Question re: focused ultrasound

HI Marc,

There is not anyone in the US doing the PTT that I am aware of…if you are looking for that procedure, then the best bet is to go to Dr. Jeanmonod. The folks in the US are doing the globus pallidus treatment in the clinical trial that I sent previously.

Tim

From: Marc Anderson [mailto:marcbanderson@gmail.com]

Sent: Monday, June 10, 2019 5:37 PM

To: Tim Meakem

Subject: RE: Question re: focused ultrasound

Dr. Meakem,

I somehow missed your email and just now saw it. My apology.

Thank you so much for your thorough reply.

I'm looking for a clinic does the same procedure/target, the pallido-thalamic tractotomy done by Dr. Jeanmonod at the SoniModul clinic in Solothurn, Switzerlandy. Do you have a link of such locations or can you direct me to where I might look?

Thank you.

Marc Anderson

From: Tim Meakem [mailto:tmeakem@fusfoundation.org]

Sent: Monday, May 13, 2019 9:02 AM

To: marcbanderson@gmail.com

Subject: FW: Question re: focused ultrasound

Dear Marc,

Thank you for your inquiry, and I am very sorry to hear that you have been suffering from Parkinson’s disease. Let me give you the latest.

Before I respond, I am required to state that the Focused Ultrasound Foundation is not a medical facility and we cannot and do not give medical advice. Please note that the data on our website is provided by focused ultrasound (FUS) manufacturers and sites; this information is based on the last update received and may not be current. This resource may help you formulate questions to ask your physician to make an informed treatment decision, and the absolute latest information and options will come from the physicians.

The situation for the Parkinson’s disease clinical trial, is that the inclusion criteria (number 4) is that you have to be “levodopa responsive”. This decision is made by the actual site, so I would look at the information attached, and contact a convenient site (contact information is near the end) and inquire of them. Sometimes the level of response is present, but the decision may be made to not continue the treatment because the amount of improvement was insufficient to warrant continuation. This is really a clinical decision, so it is best to ask the site.

If you are inquiring about the FDA approved treatment for Tremor Dominated Parkinson’s disease (TDPD), then this is something that I would contact a treatment site, and inquire of them. Any of these sites can treat this disease insightec.com/us/treatment-..., and they can answer this question.

If you want to stay in touch with the latest releases from FUS, please subscribe to our free, email newsletter, as we release general news and announce clinical trials every month. This can be found at the bottom left of our website (or at fusfoundation.org/newslette....

I am sorry that I cannot answer the question myself, but I hope that the information that I have provided will help you get the answer. If you have further questions for me, please let me know. I do wish you all the best as you seek optimal treatment options for your Parkinson’s disease.

Sincerely,

Tim

Tim Meakem, MD

Chief Medical Officer

fusfoundation.org

tmeakem@fusfoundation.org

From: Marc Anderson [mailto:marcbanderson@gmail.com]

Sent: Sunday, May 12, 2019 8:52 PM

To: info@fusfoundation.org

Subject: Question re: focused ultrasound

Dear Sir/Ma'am,

I have Parkinson's. To qualify for focused ultrasound, does a person have to run their course on Sinemet to Paris no longer effective or, as in my case, I've never had a response to it? I was diagnosed in July 2011 and have taken Sinemet on and off for months at a time, but seem unaffected by it.

Thank you.

Marc Anderson

St. Paul, Minnesota

pdkid profile image
pdkid in reply toParkie-

Hi Parkie, What made you choose Sonimodul over trials in Canada? We are in Canada, so it would be a lot easier than going to Switzerland (though we are currently in talks with them). Thanks!

Parkie- profile image
Parkie- in reply topdkid

Hi pdkid

PTT can be done on both sides. Also because Dr Jeanmonod has been doing this procedure for a long time. But mostly because I am non-tremor dominant and PTT covers rigidity and bradykinesia. However, looking at jacksmar's successful experience, I am wondering more and more if possibly both procedures are equivalent.

pdkid profile image
pdkid in reply toParkie-

That makes total sense! Just want to make sure I cover all my bases. My dad is also rigidity dominant. I also would feel more comfortable with the years of experience. How long from the time you booked till your appointment did you have to wait? Thanks a lot!

Parkie- profile image
Parkie- in reply topdkid

I may be wrong, but I got the impression that non-tremor PD is not Dr Jeanmonod’s priority or preferred patients. It was quite a while to get an assessment appointment :

I sent in my original request to submit my case in November 2019 and instead of being asked to send my medical file and video like others usually are, I got an email saying Dr J needed a phone appointement for 2 weeks later. That phone appointement lasted less than 5 minutes and he only said to send in my stuff by email without asking me further information on my case...

After he received my stuff, he said he didn’t know if I was a good candidate or not and offered a 2-day testing package for 4000 canadian $. I asked a few questions and instead of replying by email, he set yet another telephone appointement for 2 weeks later that lasted less than 5 minutes where he only said I can't tell if you're illegible or not, you have to come here. I asked if it's because I am non-tremor dominant, if it's because of my fast progression and so on, he would not answer.

So I accepted his offer and Mrs Rossi sent me a package for May 2020 for a one day testing programme instead of 2 days. So I accepted that "as is" because any questions would have given me extra weeks delays...

pdkid profile image
pdkid in reply toParkie-

Huh, interesting, really good to know. Whats your status now with them? Thanks so much for sharing, really appreciated.

I guess what Im worried about is my dad not qualifying since dopamine works for him part of the time. But like it really only lasts 2 hours and he freezes in between and is pretty much debilitated during those episodes. (sometimes up to 6 hours a day). Overnight is the worst.

Parkie- profile image
Parkie- in reply topdkid

My May flight was canceled so I contacted Sonimodul and got my appointment moved to September. If he determines I am a candidate for FUS PTT, we have to plan another trip a few months later (waiting list). He said he absolutely cannot merge both appointements. So, even without Covid crisis, I doubt I could have had the procedure within a year from first contact...

pdkid profile image
pdkid in reply toParkie-

Got it. Wow i didn't realize we'd have to go over there twice, but I guess that makes sense. Thanks so much and best of luck, hope it all goes well...! Please keep us posted!

Lana666 profile image
Lana666 in reply topdkid

Hi PDkid, did you send them your data first and were asked to come after data review? Or they didn’t offer to send data but only visit? Also if it’s ok with you to share I wonder how do you present your dad case. I am asking those questions as I am preparing data for submission. I emailed them and got a response overnight with the list to submit. And now I’m afraid to submit , cause I am non tremor dominant. I also have good on times throughout the day, between dystonia spasms with excruciating pain often.

pdkid profile image
pdkid in reply toLana666

Hi Lana,

I emailed and explained interest, and they asked for us to send medical notes, a recent MRI brain scan and videos of all the listed actions. They haven't said anything much other than to let them know when we are ready to send all the info. We are just gathering everything at the moment and hoping to send it all in in the next few days.

I am going to send one video of my dad when he is off, and one when he is on. The best we can do is be honest with them and hope for the best.

Things I will be sure to note:

- his sinemet barely works anymore... took almost 45 minutes to kick in sometimes, and lasted only an hour. we switched to mucuna and he currently takes the sinemet for the carbidopa.

- with his sinemet, he takes 18gr of mucuna powder, with a teaspoon of psyillum, and some doses have choline, with one glass of lemon water. this is every 3 hours, sometimes less than 3 hours. and even with this, he experiences 20-30 minutes of freezing in between each dose. we cant increase his dose or otherwise its too much for his body

- he is also on 12mg of neupro patch which we are trying to wean off of because of the hallucinations and sleep disturbances (so far reducing from 16mg has helped so much)

- overnight, he can barely move

- he suffers from bradykinesia, dystonia, akinesia, pain, sometimes dyskinesia

- his neurologist recently referred him for DBS, but we prefer FUS !

Hope this helps and best of luck

Lana666 profile image
Lana666 in reply topdkid

Thank you very much Pdkid for detailed info. You seconded my intention to send OFF and ON videos. Good luck to you. Hope for the good outcome for our submissions.

Parkie- profile image
Parkie- in reply topdkid

Hi PDK,

I noticed that your dad is rigidity dominant and is taking choline. Although it doesn't seem like he is taking alot, I think you may want to read about Kia17's experience with choline:

‘’Choline … increases Acetylcholine could exacerbate Rigidity- dominat PD symptoms but helps others like tremor-dominant PwPD’’

healthunlocked.com/parkinso...

She also did other posts on what helps her dystonia/rigidity and it turns out it was about the same for me.

Every little bit helps...

pdkid profile image
pdkid in reply toParkie-

Oh wow, thank you so much for this valuable info. I will definitely look into it. The Choline was recommended by his naturopath to help with dopamine absorptions (?) Every little bit definitely helps. What are you finding has helped you the most with your stiffness? So so so appreciated, Parkie

Parkie- profile image
Parkie- in reply topdkid

I took choline a couple of times because definitely recommended for pwp. However, for me, it translates into worsening of pd. Unfortunately, haven't found anything that helps with stiffness except for the magnesium oxyde, malate, glycerophosphate mix. Can't take Magnesium threonate or citrate as they exacerbate my REM sleep disorder...

Lana666 profile image
Lana666 in reply toParkie-

I've been taking citocholine on and off several times for few month, stopping actually after reading Kia's post. But was not able to see any correlation. The same as with some other items on her list. I wonder if it because my dystonia is much more prominent and those small variations are not significant, don't know. A significant trigger for me is a sugar spike in the blood (carbs consumption or a large meal). If I have it in the eve, I may clean my calendar for next day and prepare to stay bed with dystonia.

pdkid profile image
pdkid in reply toLana666

My dad is the same... after a big meal he experiences freezing and stiffness and pain more than usual... i think his might be related to digestive issues though, because once his meds finally kick in, he is ok again.

Parkie- profile image
Parkie- in reply toLana666

Most items on Kia17's list that are bad for her are usually bad for me too, but unfortunately, items good for her dont really help me...

Good carbs (some fruits and whole grains) are ok for me, but bad carbs (chocolate or any other sweets) completely cancel any little benefit levodopa carbidopa has on me. Protein does the same.

Lana666 profile image
Lana666 in reply toParkie-

What a life we have, deprived even in a little pleasure like chocolate;)

Despe profile image
Despe in reply toParkie-

Parkie,

There are organic chocolates (70 to 90% dark) that are sweetened with stevia.

MBAnderson profile image
MBAnderson in reply toParkie-

pdkid,

This is from the paper he published re the 51 consecutive cases setting out his selection criteria.

"Selection Criteria

Selection criteria for MRgFUS PTT included (1) idiopathic PD (diagnosed by neurologists), (2) chronic disease with at least 1 year of therapy resistance, characterized by (a) insufficient efficacy of L-Dopa dosed up to at least 600 mg L-Dopa equivalents per day, with symptom control during maximum 50% of the day, (b) gastro-intestinal or other side-effects, (c) fluctuations (on-off phenomenon), and (d) on-medication dyskinesias (choreoathetosis), (3) intensity of symptoms (intensity of tremor at rest and/or hypobradykinesia of 3/4 or more), (4) strongly diminished quality of life, and (5) Montreal Cognitive Assessment (MoCA) test in the norm or reduced but not below 20/30. Three subtypes of idiopathic PD were considered (55): the tremor dominant (TD), the akineto-rigid (AR) and the mixed form (MX). Asymmetry of symptoms was not a selection criterion. No prefixed age limit was set. All patients were examined by a senior internist for any medical contraindications. Antiaggregant therapy was stopped for 10 days before the intervention, and normal coagulation and blood pressure were checked for all patients prior to surgery."

As I read it, there is a lot of wiggle room. (4) strongly diminished quality of life. That allows them to take anyone they want.

My theme was, C/L most of the time didn't do much for me. My only suggestion would be that you emphasize he's no longer very responsive to Sinemet.

pdkid profile image
pdkid in reply toMBAnderson

Hi Marc,

Thank you for sending this. Really helpful and makes me more hopeful! I'll be sure to hit all the pertinent points when I send all the files back to Switzerland. Also, great hot tip on the C/L (which is also true for my dad). - april

MBAnderson profile image
MBAnderson in reply topdkid

Hi April,

When I had my telephone conversation with Dr. J, that was the only thing we talked about and so I think that was much of his decision.

Marc

pdkid profile image
pdkid in reply toMBAnderson

Thanks so much for sharing, Marc, really helpful.

*fingers crossed...* will def keep everyone posted.

-april

Lana666 profile image
Lana666 in reply toParkie-

Parkie,

One of the study sites is at Ontario, don't know if it's close to you though.

MBAnderson profile image
MBAnderson in reply toLana666

I called Ontario when I was looking to get into this trial and they said they don't take US citizens. Only Canadian citizens.

jnorwood1 profile image
jnorwood1

Thanks for info MBAnderson!

Lana666 profile image
Lana666

Marc, I mentioned Ontario after checking Nicole's info.

MBAnderson profile image
MBAnderson

In rethinking the answer to the question, "When will PTT be done in the US?" there are 2 encouraging factors that point to an answer.

1) Think about what is involved for a US neurosurgeon to get involved in the FUS pallidotomy trials? They are well-versed in FUS outcomes from around the world well enough and motivated enough to convince the hospital (review boards and lawyers) where they practice to investment serious $$ to get set up to conduct trials.

2) that means they are all very familiar with Dr. J's work. Any PD neurosurgeon moving along the evolutionary line of FUS is going to want to practice the most sophisticated, most effective outcome procedure which they all know it's PTT.

In other words, so when the clinical trials are all finished and all the data has been published, at that time many of those neurosurgeons will be exploring routes to do PTT.

5 years is not unrealistc, IMO.

Lana666 profile image
Lana666 in reply toMBAnderson

My guess is that it shouldn't be to difficult for doctors who have been doing any kind of FUS neurosurgery with ExAblate system to master PTT. Agree with Marc that even an expert of Insigthec equipment needs to do number of cases to figure out how to customize parameters for different patients based on their symptoms and neurological evaluation. I think the main issue is still lack of data for all three procedures to make a decision on which is most beneficial for certain symptoms/patients and long term effectiveness. This paper hindawi.com/journals/pd/201... gives a good presentation on this problem and how it's currently viewed in the field:

"To date, it is not clear what will be the best target for treating PD symptoms or whether different targets should be used for different patients. Another question that has yet to be answered is whether bilateral treatments can be performed since currently all treatments are unilateral in order to avoid possibly serious adverse events. "

Another fair point authors made is that SoniModul reports their results using a modified UPDRS score, which complicates an adequate comparison (referred as Magara paper in the quote bellow):

" It is not clear which target is most beneficial and whether different targets should be chosen for different symptoms. What makes it hard to compare the targets is the use of different treatment outcome measures. For instance, we used the original motor UPDRS (part III) [25, 26] as our main outcome measure, while Magara et al. [29] used a self-modified UPDRS-motor score, making the scores not comparable. Interestingly, the improvement in the UPDRS-motor scores reported by Magara and by us shows similar improvement (11.3 points in Magara’s paper and 11.5 points in our paper), suggesting similar improvement in both treatment targets. More information regarding efficacy and adverse events will be needed in order to answer this question."

It looks that the limiting step is a completion of ongoing trials and a multiparametric evaluation of data. And as of timeline suggested by Marc, I am less optimisti . If they would include long term efficacy in the evaluation (hope no more than a year) it means few more years to complete ongoing pallidotomy studies plus follow up time, add few more years to conduct clinical studies in US and submit to FDA. Unless the comparison will be performed with already analysed data of few completed pallidotomy studies. Or if there will be a spark of interest to this technique due to an extra stirring within patient community like forum discussions, seminars and other activities, which may prompt speedier initiation of clinical studies. Or perhaps Insightec will be interested in a pilot study of their new equipment for this procedure?

MBAnderson profile image
MBAnderson in reply toLana666

Good paper. The sections you quoted are key. There is lot they don't know, but few will want to wait 5 years till all of those juries come in.

Lana666 profile image
Lana666 in reply toMBAnderson

Exactly the point for many. Though it could be a right time for other members of this group.

MBAnderson profile image
MBAnderson in reply toLana666

On the other hand, the newbies have the luxury of waiting until this gets sorted out

Lana666 profile image
Lana666 in reply toMBAnderson

Also the 9 years time gap of Dr J experience ...

MBAnderson profile image
MBAnderson in reply toLana666

I agree. When someone is dinking around on the inside your brain, experience counts

lenamm profile image
lenamm

I wonder if others will be able to get the same results as Dr. J who is an expert on this procedure? There is definitely some surgeon skill required. I just hope he is able to pass on his skills to many beyond just Dr. Galley before he retires.

MBAnderson profile image
MBAnderson in reply tolenamm

I'm confident that other doctors will be able to duplicate his outcomes. I assume the doctor who is doing the trials in Japan, who has not trained with Dr. J will do a better job on his 100th patient that he does on his 2nd patient, but there's no way around that.

lenamm profile image
lenamm in reply toMBAnderson

I've pretty sure the Japanese team did train with him. Sorry should have mentioned them also, not just Dr. G

MBAnderson profile image
MBAnderson in reply tolenamm

Terrific. Then I would be confident in their quality.

nkurilskaya profile image
nkurilskaya

Thank you so much. Good luck. Natalya

chartist profile image
chartist

I was not very impressed with the speaker. She was hard to follow between the sound dropouts and her saying, "uh" more than just frequently.

Art

MBAnderson profile image
MBAnderson

youtube.com/watch?v

MBAnderson profile image
MBAnderson

youtube.com/watch?v=DtPwfih...

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