I'm wondering why Michael J. Fox does... - Parkinson's Movement

Parkinson's Movement

18,113 members18,338 posts

I'm wondering why Michael J. Fox does not have the FUS!?

ion_ion
ion_ion

Maybe he does not have the money!? I doubt!

153 Replies
oldestnewest

I believe because he's had DBS.

lenamm
lenamm in reply to MBAnderson

Nope but he had surgical thalmotomy

ChrisWF
ChrisWF in reply to lenamm

Yes, Bruce Cook performed surgical thalamotomy on him in the late 90s.

MBAnderson
MBAnderson in reply to ChrisWF

Thanks. Interesting. As I said below I would not have a thalamotomy much less a surgical 1. I think he's very lucky.

Smart

Perhaps because the procedure is permanent and irreversible with possible side effects.

"When done on both sides of the brain, FUS may cause speech, swallowing or memory problems. So doctors only do the procedure on either the right or the left. (This means it only helps symptoms on one side of the body.) Other potential side effects include rare bleeding or skin infection."

michaeljfox.org/news/focuse...

Grumpy77
Grumpy77 in reply to rescuema

"So doctors only do the procedure on either the right or the left. (This means it only helps symptoms on one side of the body.)"

Not true rescuema, at least for the Swiss procedure, a number of HU members have done (or planning to do) their second side

rescuema
rescuema in reply to Grumpy77

I understand and know that a few members here are waiting for the bilateral procedure by the Swiss. In the US, however, the procedure is still considered experimental and I'm not sure if they're performing bilateral procedures outside the trials as of yet. I simply copied/pasted what's currently stated in the MJF article, as applicable for why MJF hasn't volunteered for the procedure for the OP's question.

Older interview:

youtube.com/watch?v=m3N27Ou...

MBAnderson
MBAnderson in reply to rescuema

FUS was FDA approved in December 2018 for tremor dominant Parkinson's, so I don't know if that means we should consider it experimental. Also, it's a different target in the US. It's a pallidotomy, not a PTT.

fusfoundation.org/the-found....

rescuema
rescuema in reply to MBAnderson

Here is the list of the trials, last updated 10/22/2020. Still all unilateral except the one pallidothalamic tractotomy trial recruiting in Japan.

"At this time, focused ultrasound is only being assessed to treat one side of the brain, so it will affect tremor or dyskinesia unilaterally. Studies are being organized to assess the possibility of treating patients bilaterally, and one is included below. "

fusfoundation.org/diseases-...

MBAnderson
MBAnderson in reply to rescuema

The problem is, as we know, FUS is moving to the US at a snail's pace.

I think it would be a very interesting article if somebody would interview a dozen US based neurosurgeons as to why that is.

rebtar
rebtar in reply to MBAnderson

My neurologist said (as she rolled her eyes) most of the good stuff starts in Europe long before it comes here (to US).

jeeves19
jeeves19 in reply to rebtar

Ha. We always think the opposite!

Drummer67
Drummer67 in reply to MBAnderson

Great point Marc

rescuema
rescuema in reply to MBAnderson

I assume the threat of medical malpractice lawsuits has something to do with it. The US is very litigious.

acsh.org/news/2019/12/27/bl...

MarionP
MarionP in reply to rescuema

Less litigious lately, many states have enacted damages caps.

rescuema
rescuema in reply to MarionP

Can't be great for the lawyers.

GioCas
GioCas in reply to rescuema

Perhaps because in Switzerland "defensive medicine" is practiced less?

MBAnderson
MBAnderson in reply to rescuema

Very interesting interview.

I feel much the same way he does. I don't want anyone dinking around in the center my brain on the basis of, "probably/maybe this will help."

youtube.com/watch?v=fmkZAV4...

rescuema
rescuema in reply to MBAnderson

Yes, totally. He doesn't want any "mechanical stop-gap or pacemaker" and wants something more fundamentally curative.

park_bear
park_bear in reply to MBAnderson

Interesting to note dyskinesia and only mild tremor as compared to the first video in this thread which was recorded at an earlier date.

MBAnderson
MBAnderson in reply to park_bear

I noticed. I wanted the post his more recent interview with Jane Pauley, but the link didn't work. Same thing.

rescuema
rescuema in reply to park_bear

I remember watching one of his other videos where he demonstrated he could will his state of dyskinesia simply by conscious focusing. I assume he tried harder on JF live audience show.

Edit: Here's the video 7:00 mark

youtube.com/watch?v=Xm9tKou...

ion_ion
ion_ion in reply to rescuema

This is valid for any other place except Sonimodul in Switzerland.

MBAnderson
MBAnderson in reply to rescuema

To be more precise, the article should have said, "... when done on both sides..." at the same time.

rescuema
rescuema in reply to MBAnderson

Wouldn’t that depend on which procedure?

Is that what Dr J told you on pallidothalamic tractotomy?

MBAnderson
MBAnderson in reply to rescuema

I don't know if it depends on which procedure. I suppose it depends on how far apart the 3 targets are from each other or from that area of the thalamus that governs speech and walking.

Yes, Dr. J said that's 1 of the reasons he waits a year, so I believe it at least applies to PTT The other reason he waits is because it might be the case that a person does not need to have both sides done.

rescuema
rescuema in reply to MBAnderson

The below 2017-2018 study article by SoniModul Ltd. center thoroughly discusses the MRgFUS PTT.

"In our opinion, PTT is an optimized form of pallidotomy, because (1) it provides a maximal amount of suppression of overinhibiting pallidal output to the thalamus in a much smaller volume, (2) it avoids the lenticulostriatal domain, thus reducing the vascular risk of pallidal surgery, and (3) the surgical risk for the optic tract is suppressed and reduced for the internal capsule. This allows symptom relief without reduction of the thalamocortical dynamics, which is essential for our whole sensory, motor and complex mental functions. "

The stats are quite elucidating -

Bilateral PTT15

PTT left35

PTT right32

Centrum medianum thalamotomy (CMT)2

Total targets69

2 targets in one session13 (11 bilateral PTT, 2 CMT)

Tremor (/12)*84% (0.8 ± 1.2 vs. 5.2 ± 4.0), 83.3% improved, 8.3% stable and 8.3% increased24<0.001

Rigidity (/8)†70% (0.9 ± 1.3 vs. 2.9 ± 2.0), 88% improved and 12% unchanged24<0.001

Distal hypobradykinesia (/16)§73% (2.0 ± 2.0 vs. 7.3 ± 3.9), 96% improved and 4% unchanged24<0.001

Axial items (/32)¶24% (6.0 ± 4.1 vs. 7.8 ± 4.0), 67% improved, 12% stable, 21% worsened240.13

Speech (/4) (UPDRS III item 18)38% (0.5 ± 0.7 vs. 0.8 ± 0.7), 46% improved, 42% stable, 13% worsened

ncbi.nlm.nih.gov/pmc/articl...

MBAnderson
MBAnderson in reply to rescuema

Indeed - impressive outcomes.

tps://healthunlocked.com/parkinsonsmovement/posts/142437802/mrgfus-pallidothalamic-tractotomy-for-chronic-therapy-resistant-parkinsons-disease-in-51-consecutive-patients-single-center-experience

rescuema
rescuema in reply to MBAnderson

You've mentioned that the FUS PTT result may last 6 years or more. What options would one have if the symptoms revert with further progression? I assume you've discussed this with Dr. J in detail?

MBAnderson
MBAnderson in reply to rescuema

Did I say 6 years?

They would have the exact same options they would have as someone who didn't have the surgery, except for several years of respite.

If my progression stops for several years and then somebody asked me, "Why would you have the surgery if it only lasts several years?" I'd say, "You don't have Parkinson's do you?"

ChrisWF
ChrisWF in reply to MBAnderson

For me, the risk is that PTT makes me inelligible for, or reduces the effectiveness off, some future thing.

If i was 74, however, i'd very likely do what you did, since these future things don't yet exist and probably wont for many years.

MBAnderson
MBAnderson in reply to ChrisWF

Pretty much my thinking.

If some future therapy is a pharmaceutical which cleans out the gunk or prevents it from forming or stem cell manipulation, I don't know if lesioning an overexcited pathway would preclude that.

Besides, I don't like the odds of giving up improved quality now to gamble on something curative for preventative in the next 5 years.

Case #s (n = 51) is impressive? Think about why he "cherry picks" who he operates on.

If he is picking people based on believing he can produce the best outcome, that is, do the most good, what would be a more appropriate criteria?

Why would any surgeon pick a patient where he can only produce a marginal benefit?

"Why would any surgeon pick a patient where he can only produce a marginal benefit?"

Hopefully it happens more often than not because it is reality in democracies. If we only gave PD drugs to those who would benefit the most, it would be a pretty sick PD world indeed.

Sharon

Performing a very expensive surgery that is irreversible on a patient who might only slightly benefit can’t be compared to prescribing medication which can be stopped at any time if the side effects are unpleasant.

"Performing a very expensive surgery that is irreversible..."

PPt/FUS surgery is only "very expensive"in your mind because 1) it is out of pocket, and 2) you need to travel to Switzerland to a specific surgical team for a specific procedure. In general it may not prove cost effective (probably) on an national insurance coverage basis for those PwP > 65 years of age since PD has an extremely low mortality rate (US CDC claims 98 per 100,000 for males over 65 which = .00068%; much lower for females = .00043%)

FYI, a coronary bypass, which is irreversible also, costs about $75,000 - 100,000 as a national average for the US (covered by US Medicare and VA). So, it is basically free for those covered.

Yes, CBS is often of marginal benefit. Probably most of the time for those > 80, even > 70, which is why for some government health officials in medically controlled countries it remains controversial and should be considered "elective."

Yes, you can get CBS cheaper in the Canada, EU and UK, and much cheaper in China, which is why people with serious money from all over the world go to Mayo or Cleveland Clinic.

Sharon

what's your point?

ChrisWF
ChrisWF in reply to MBAnderson

Could go some way towards explaining why it isnt more widely practiced.

MBAnderson
MBAnderson in reply to ChrisWF

Chris,

I asked the doctor who is the director of the Focused Ultrasound Foundation that question and here is his answer.

"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"

ion_ion
ion_ion in reply to MBAnderson

Marc, just curios: did they ask you to sign non-lawsuit papers prior the FUS?

MBAnderson
MBAnderson in reply to ion_ion

no

Parkie-
Parkie- in reply to sharoncrayn

DBS is also cherry picking than: I was turned down for DBS but very thankful I was accepted for PTT. Being med resistant and pd progressing fast, sure glad I fall into some category for treatment somewhere in this world.

Parkie-
Parkie- in reply to Parkie-

And I see nothing wrong with having selection criteria , either for DBS or for PTT. One either qualifies or doesn’t! I didn't say the conventional neurosurgeon was cherry picking when he turned me down: I don't say it's because he wants a perfect score on his results! Of course all neurosurgeons only operate on patients they know they can help!

rescuema
rescuema in reply to Parkie-

Were you provided the specific reason for the DBS disqualification? Was it due to surgical risk or because it was determined you may not benefit from it?

FUS PTT advantage is obvious - you recover in no time and only need to shave your head.

However, DBS does offer the ability to recalibrate (or cease) and adjust the settings as symptoms progress over the years, and it may be reversible albeit surgical risks compared to permanent brain lesioning and people would not have to travel to Switzerland with the huge out of pocket cost with no insurance coverage. Earlier on, DBS was also said to stop the progression but the survey shows that it doesn't.

Parkie-
Parkie- in reply to rescuema

Disqualified from DBS because they think I might not have pd but rather MSA. However, dr Jeanmonod had already diagnosed pd and accepted my case.

I went to this other neurosurgeon (in Montreal) a couple of weeks ago because it was a one year follow-up appointement. Last year, they had rejected me because it hadn't been 5 yrs since diagnosis. I don't know if I would have gone through dbs anyway, I mostly wanted to know what fus procedure was done here. Turns out they do fus for essential tremor and for pd tremor. I am non-tremor, so I don't qualify either.

rescuema
rescuema in reply to Parkie-

I truly hope Dr. J is successful to address your symptoms. I just wish the PTT treatment could be more accessible for everyone else with limited treatment options. I'm rooting for you!

MBAnderson
MBAnderson in reply to rescuema

To be clear, I do not mean to and would not discourage anyone from exploring and/or having DBS. As you point out, PTT is not available to everyone and in many cases insurance covers DBS, making it free. I do not know the exact figure, but I'm confident the vast majority of people are happy with their outcome. If I were in an advanced stage, I would seriously consider it for myself.

rescuema
rescuema in reply to MBAnderson

I understand Marc. There are too many questions still left unanswered because we simply lack long-term data on both sides.

To me, the advantage of DBS sits on the claim that it may be reversible.

"Because DBS is reversible and causes no permanent brain damage, use of innovative not-yet-available treatment options may be possible. Thalamotomy and pallidotomy result in small, but permanent changes in brain tissue. A person's potential to benefit from future therapies may be reduced if undergoing these procedures."

my.clevelandclinic.org/heal....

However, the reversibility claim of DBS is being challenged as the article below discusses.

"They note the possibility that prolonged stimulation of this sort may produce long-term neural reorganisation underlying the persisting clinical effect. Maslen et al have also described a case of unexpected complications of DBS treatment for chronic pain, in which two patients developed de novo epilepsy following treatment. There is also some emerging evidence of non-stimulation-dependent psychiatric effects of DBS in depression...

We have insufficient evidence to establish with certainty the truth (or falsity) of the claim that DBS is (or is not) reversible over long periods of time...

Ruge et al hypothesise that neural reorganization may occur in patients who have received long term-stimulation of more than 4.5 years...

Absence of evidence is not evidence of absence, and we do not have sufficient data about the effects of long-term brain stimulation and/or the tissue damage caused by electrode implantation to be certain about their effects on patient well-being...

However, the reversibility that DBS does exhibit can be of considerable moral significance. "

jme.bmj.com/content/45/4/225

This certainly complicates the decision process for PWP, especially for the younger folks with options.

MBAnderson
MBAnderson in reply to rescuema

It's a really tough decision. I do not envy you. The only first-hand experience I've had with DBS is having met a woman (in her late forties) several years ago who had it 5 years prior to our meeting and she was very happy with it.

Do you think there is such a thing as DBS support groups so you can talk to people who actually had it?

Again, if I were in an advanced stage and functionally disabled, I would have it.

MarionP
MarionP in reply to MBAnderson

Are you saying the drastic side effects\complications of SIMULTANEOUSLY bilateral, doing both sides, as opposed to doing one side and then later down the road doing the second side?

lenamm
lenamm in reply to MarionP

If I am understanding your question correctly - yes there is more risk of doing both sides together than staging with at least a year apart. The one person I know who had PTT bilaterally at the same time has some speech issues as a side effect. She is still very pleased with the results and for her the speech issues were worth the amount of improvement she received (she holding steady 3+ years later). But I believe that is why Dr. J will almost never recommend bilateral at the same time.

MarionP
MarionP in reply to lenamm

Yes, I have seen several studies and reviews stating the danger of significant cognitive and dementia and tremor and language and movement problems after receiving BOTH sides done, but not clear whether that means you cannot have both sides done EVER, or whether they can both be done but not at the same time and instead have a minimum period after which it is safe to do the other side. That was my intent to ask.

I believe he had an early version of it in the late 90s so he probably can't get it.

He had a surgical lesioning thalmotomy on one side already so would not qualify

MBAnderson
MBAnderson in reply to lenamm

Not for me.

It was 1998, to be fair.

MBAnderson
MBAnderson in reply to ChrisWF

Brain surgery 22 years ago feels to me like the dark ages. Do you think they used scalpels?

ChrisWF
ChrisWF in reply to MBAnderson

Lol probably.

"The scene conjured up Dr. Frankenstein’s lab more than an ultra-modern operating theater, not because of the hospital, but because of the novelty of the surgery itself. It was intensely computer-aided. Using anatomical landmarks on an MRI, Bruce guided a test electrode through a tiny plastic tube down into Michael’s right thalamus. He warmed it up a few degrees, and the tremor, once violent enough at times to knock a glass off the table, stopped in its tracks. That was the sign that the location was correct, that the procedure would work."

lenamm
lenamm in reply to ChrisWF

Dr. J used to do PTT the same way before FUS

delboy381
delboy381 in reply to lenamm

How much does it cost this treatment, do you know?

MBAnderson
MBAnderson in reply to delboy381

Fr.35,000

delboy381
delboy381 in reply to MBAnderson

Thank you.

MBAnderson
MBAnderson in reply to lenamm

I am suspicious that critically important functions are only separated by fractions of a millimeter -- and can a scalpel be that precise and what is the likelihood that they know precisely where one function begins and another one ends, really?

You will find out in less than 6 years.

Unless the benefits last longer.

MBA

The benefits won't last. If their FUS did last, they would promote the extension. Normal distribution says 6 years at most, probably less since they don't provide any "longitudinal" data, if you know what that means, which is so , so, so convenient. Love it.

Replaying DBS early hype. Fore taste of stem cell hype. Where is the "meat"? Oh...our hamburgers are all chemicals...don't you know.

Sharon

What is "the extension?"

I'm sill waiting (yawn) for your detailed "pre/post" assessment of PTT/FUS Swiss brain surgery where you specifically provide detailed info on:

1) drugs and doses you were on (pre) and drugs and doses reduced or dropped (post)

2) UPDRS part 3 and part 4 scores from same qualified neuro pre and post.

3) DaT/Spect scan results pre and post.

Since you passed 4th grade composition (Sister Rose gave you a passing grade out of the kindness of her heart) and bitterly complain about "how long" the clinical trial reports take to make it to publication, I expect your pre/post interim report on my desk COB.

sharon aka crayon crayola

Ms. Crayon,

I agree that a lot of my comments are yawners. (PWP who have a hard time sleeping can take their laptop to bed and read my stuff- so it's not a total waste.)

Sounds like you missed my 1 month, 3 month, and 6 months post-op reports? They're pretty detailed and are threads under my profile if you're interested.

As it happens, I just sent Dr. J my 9 month report (a couple weeks early) as we are trying to schedule my 2nd visit and here's what I said.

"PD still feels gone from my left side. No tremor at all in my left hand. No back pain, rigidity/stiffness on my left side and no minor dystonia in my left toes.

My walk is slightly clumsy, but not bad and my left arm swings well.

I had a jaw tremor which only appeared at night when in bed trying to go to sleep, but that seems to have faded away, mostly. Turning over in bed was relieved postop, but is now difficult again.

Constipation was completely relief for exactly 2 months after the procedure, but then returned and is as problematic as it was pre-op.

My right hand tremor has worsened considerably. When I rest my arm on the armrest of my chair or on a tabletop, thereby stopping full amplitude, the tremor is conveyed up my arm, through my shoulder, and across my chest. My right shoulder is painful most of the time with limited range of motion. I cannot use my right hand for anything. This tremor interferes with my sleep.

A few friends which I had not seen since before the procedure said the post-op improvement is obvious, that my body appears more relaxed and I have minimal facial mask.

My wife feels I have become slightly less steady over the past few months, which I agree with. Gait initiation was a problem pre-op, was greatly improved post-op, but is now problematic again, but not quite as bad as pre-op.

I walk 2 miles (50 minutes) every day on cross country ski trails (small hills) with 2 pound ankle weights and I do one hour of calisthenics twice/week via video led by a PD physical therapist which includes several segments of high intensity intervals.

I take one 50/200 extended release Sinemet at bedtime 5 or 6 nights/week and I sometimes take a 25/100 IR if going out, although I haven’t had a Sinemet in two weeks hoping it might help with constipation and because I don’t really benefit from it anyway.

I have no mental or psychological issues, no depression or hallucinations. I don’t even have bouts of sadness. My memory could be better, but it’s not bad. I’ve been working on it and have improved it over this past year. "

chartist
chartist in reply to MBAnderson

Marc,

Thank you for the 9 month update!

Art

I don't know what my UPDR score is, nor do I know any of the Datscan info.

UPDRS change was a primary endpoint in his case study! Did you even read the study?

MBA

These are your personal ("not quite as bad")and somewhat non-rigorous observations (your friends and wife) which are certainly relevant in your personal context, but have little validity in assessing in a clinical manner the efficacy of the intervention (which was a non-randomized, unmasked intervention) undertaken to improve your PD on the basis of a list of multiple outcomes.

We are talking apples and oranges here...which is why I asked for your pre/post UPDRS PART 3 and 4 from the same neuro and your DaT cans from the same imaging radiologist. You don't apparently have them.

If PTT FUS is going to enter the medical mainstream, personal observations won't get it there. Especially when the interventions similar to yours are limited in number.

My perspective is strictly clinical.

Sharon

You might be interested in my reply above quoting the doctor who is the director of the FUS foundation offering his opinion Re: FUS entering the mainstream. Essentially, he agrees with you.

thank you...at least that comment was objective. I'll take whatever I can get.

Parkie-
Parkie- in reply to MBAnderson

'' I just sent Dr. J my 9 month report (a couple weeks early) as we are trying to schedule my 2nd visit''

Is your visit scheduled?

Jesus, Sharon, what gets into you and your head from time to time? I admit that I don't follow every single post and reply that you write, but then again I do find that you tend to lash out. Here's a fine example in this thread. Why would you couch your words so hurtfully to Marc? It doesn't matter that he indulges you.

First, Marc already has had the procedure done. It is no longer in his control as to whether the benefits last 6 years or 10 or 5. Given Marc's attitude, I am guessing it is likely to be more like tending towards 10. However, these things can be affected by negativity and "peer challenges" such as yours, by questioning the validity of his hope. You do enough CYA try to make it look like a joke in case this backfires like it did just now. You have probably thought about using plausible deniability in that case.

Please remember that you don't have Parkinson's. Even if you have a 100 years of experience providing support for Parkinson's patients, you can never even begin to imagine what it would be like to suffer like we do for even a 100 minutes.

Please be considerate and BTW, please do issue the apology that I asked for a few months ago, the last time that it happened. I assure you that it will be well accepted by the community and it will be cathartic for your soul. But wait, there is more'😇. It will also serve as a reminder to always be civil and genuinely engaged with the rest of us, every time you feel the urge to veer off the compassionate path.

God bless you and may God bless us all Parkinson's patients.

ChrisWF
ChrisWF in reply to pdpatient

"Jesus, Sharon, what gets into you and your head from time to time?"

Autism and/or extreme boredom would be my guess. A self proclaimed expert in basically everything with effectively zero practical PWP advice and and mostly interested in being a pedant over highly technical information that none of us will ever likely have the chance to actually use. All wrapped up in needlessly snarky delivery. Delightful. Supposedly a highly accomplished phd and PD support group leader but as unwilling to share any identifying info, could just as easily be an internet bullshitter.

PDP,

I am a clinical trial specialist who works exclusively with stage 3 and 4 cancer trials. Therefore I am not interested in a personal experience. I cannot afford to be. All I ask is for people to avoid extrapolating them.

Your guess is wrong about longevity. If your "guess" was correct, Dr. G and Dr. J would cite it. They don't. In fact, they fail to support their contention about 6 years.

Apology for what? You mean my inability to remember every worthless PD drug and/or clinical trial detail that is mentioned on HU or elsewhere... like the infamous Nilotinib/Tasigna that you thought was "major". And which I thought and knew was a joke. I need I need to apologize to you for that? You missed it by a mile. I have a full time job, and it isn't following every pronouncement on every PD drug experiment or CT.

Give me a few examples of my CYA.

Just thank God you aren't a stage 4 cancer patient. You are extremely fortunate in comparison. So try not to get overly concerned with your personal situation with your PD. It isn't worth it. The journey is long.

Sharon

What is a statistical “extension”?

An extension is an outlier or abnormal occurrence while using the standard intervention of the case study or clinical trial regardless of the appropriate statistical distribution of intervention occurrences.

Outlying occurrences are not in themselves invalid or erroneous (although it is highly likely they are especially in non-randomized interventions), but within the context of the overall statistical distribution, whatever the distribution, they should be considered irrelevant in assessing the overall efficacy of the intervention.

Extensions or outliers regardless of where they occur on the tail(s) of the distribution should not be used to validate the intervention’s hypothesis or null hypothesis particularly when the case study or clinical trial 1) extends over several years, 2) does not involve “randomization”, 3) involves multiple changes in the application of the intervention, 4 ) involves multiple measures of efficacy.

Therefore, the existence of one or more outliers does not justify promoting the efficacy of the intervention beyond the simple mean and mode of the distribution and the context of the standard deviation of the occurrences.

Sharon

GioCas
GioCas in reply to sharoncrayn

sorry but what does it have to do with the duration? I ask this for a friend. :-)

I quote: " If their FUS did last, they would promote the extension. "

sharoncrayn
sharoncrayn in reply to GioCas

is it simply an outlier or is it within the std. deviation of the statistical distribution? See my answer to MBA

MBAnderson
MBAnderson in reply to GioCas

I think she is saying the number of cases that they have tracked over many years are few and therefore do not qualify to be listed as a reliable outcome.

Parkie-
Parkie- in reply to MBAnderson

That certainly doesn't justify

"The benefits won't last"

This is hughe and has to come with scientific data. One cannot just take away hope for all the pwp for whom Fus ptt is the only available treatment option.

pdpatient
pdpatient in reply to Parkie-

Bingo!!!!!🤙 Yes, hope springs eternal🙏

thanks

pdpatient
pdpatient in reply to GioCas

LoL, Gio. Please read my post/reply above. Methinks that you all are being overly nice to Sharon.

GioCas
GioCas in reply to pdpatient

This things start to resembles something called "witch hunt" a medieval pratice 🤔

“A witch-hunt is an attempt to find and punish a particular group of people who are being blamed for something, often simply because of their opinions and not because they have actually done anything wrong.”

Another:

“witch-hunt

in British English

a rigorous campaign to round up or expose dissenters on the pretext of safeguarding the welfare of the public”.

Animated discussions are accepted, but don't do this above in my name. Torquemada has never made a positive criticism nor has he ever had good intentions in pronouncing an Autodafè.

google.it/amp/s/www.collins...

Thank you for the thorough explanation.

Sharon why are you so intent on rubbishing FUS?

"rubbishing" FUS?

Interesting term that doesn't apply to my comments. I am commenting specifically about the Swiss approach to PTT FUS (yes, different approaches to PTT FUS exist). Before I jump off the building, I want to see Gallay produce data on more than 52 interventions over more years than 2017-2018. 4th grade math says that amounts to an average of only one intervention every 2 weeks.

He has changed his protocol at least once since 2014: "A reappraisal of the histology of the pallidothalamic tract was combined recently with an optimization of our lesioning strategy using thermal dose control."

How did he measure "reduction in pain (p < 0.001), dystonia (p < 0.001) and REM sleep disorders (p < 0.01)" to that very finite degree given his hypothesis for his p score?

He writes how he did it: "Patients reported "? Seriously? You expect self reporting is quantifiable in a serious case study?

But I look at things differently than you do, obviously. Worlds apart.

Sharon

Sharon, I have had a hellish time with Parkinson’s symptoms for over a decade. Now, after FUS PTT I have my life back. I’m really relieved about that, whatever issues you may have with Dr Gallay’s scientific methods. I’m a human being, not a statistic.

MBAnderson
MBAnderson in reply to Trixiedee

Rebekah,

I'm so happy to hear you're doing so well. I was worried about you after his initial rejection, but you persevered and it paid off. Good for you.

Really, really nice to get one's life back.

Very glad to hear about your success. As I have said to both you an MBA, I was looking at this intervention very differently.

pdpatient
pdpatient in reply to Trixiedee

It's sad that you have to even say that in this forum that is dedicated to PwP.

Sharon, do you even have Parkinson’s? Or are you just here to sneer at us with your superior scientific knowledge?

ParlePark
ParlePark in reply to Trixiedee

Trixiedee, don’t find her knowledge “superior “. She does not have Parkinson’s. She seems to be a legend in her own mind.

pdpatient
pdpatient in reply to ParlePark

ParlePark, I have to say that we need to all jointly reject the tone of voice that Sharon tends to use. It's not acceptable from a person who does not have Parkinson's.

Please remember to upvote my comment and follow me.

I have had enough of this from random wannabe "do gooders" who raise our collective blood work and trash our Parkinsonian suffering.

ChrisWF
ChrisWF in reply to Trixiedee

"Or are you just here to sneer at us with your superior scientific knowledge?"

Basically, yes.

She has a point about self reporting. On the other hand, how are dystonia, pain, sleep disorder supposed to be measured if not through self reporting?

MBAnderson
MBAnderson in reply to ChrisWF

very good -- not to mention swallowing difficulties, constipation, depression, hallucinations, anxiety, falls, loss of smell, dizziness, drooling, urinary urgency, vision changes, fatigue, sexual changes, excessive sweating, impulse control disorders, etc., etc.

However, if these conditions are reported to somebody with a PhD and that person questions them more closely and writes down their answers, then the symptoms are quantified. :)

sharoncrayn
sharoncrayn in reply to ChrisWF

Exactly the point in trying to "measure" some of the outcomes of PTT FUS

pdpatient
pdpatient in reply to ChrisWF

Chris WF, I am in on this one with you. Your "enemy" is my"enemy". Let's go to war together today and then battle amongst ourselves tomorrow 😂✋🏼.

I will give Sharon exactly two hours from the time of this post to apologize to Marc, apologize to the rest of us in this forum and promise to do communicate decently or else get the hell out!!!

Trix,

Try to avoid the personal attacks. It is counter productive.

Read my profile before going off making assumptions. The profile has been on HU from the day I joined.

I have worked with PwPs (2 groups) for 10-11 years now "pro bono" so I think I know about it a little more than you think.

I would not pay one cent to be part of a PwP group which you facilitate. I wish Healthunlocked had a "block" function like Facebook so I wouldn't have to read your condescending comments. I'm not alone.

I feel very sorry you feel that way Jim. Perhaps it would help if you simply avoided reading my posts. In that way you don't even need a "block' function.

My support groups don't charge money to belong. Not even "one cent" as you put it, You do have to meet certain clinical criteria, but basically it is free. We have a waiting list so I guess your opinion is a single minority as far as my support groups go. Perhaps they have a different outlook than you do. Who knows?

GioCas
GioCas in reply to sharoncrayn

Mamma Mia.

This post is a case of high-level diplomacy.

I would say that Sharon you need a “communicator” who makes your truth acceptable to us poor people already overwhelmed by the PD who believe too much in advertising or not.😉

For the contents everything is fine, this is a discussion that without emotions or reactions would also be profitable. In my opinion.

ParlePark
ParlePark in reply to jimcaster

Jim, you speak for many of us. Thank you. As I’m sure you’d agree, HU is a support forum for the afflicted and our caregivers. One would hopefully make consideration of others a first priority.

I find many of Sharon’s posts to be self-serving, arrogant and not in the best interests of others. I no longer read Sharon’s posts.

Thank you. I appreciate it.

pdpatient
pdpatient in reply to ParlePark

ParlePark, she is being condescending to you and all of us. Should is not fit for this forum.

pdpatient
pdpatient in reply to jimcaster

Jim, Sharon needs to go.

Ms Crayola,

My decision to pursue FUS PTT was fairly simple, based on the following;

What SoniModul reports on their website, what is said on the FUS Foundation website, Insightec’s website and my extensive conversations with neurosurgeon at Wexner Medical Center in Columbus, Ohio who performed the sham pallidotomy on me and my telephone consultation with Dr J prior to travel.

I do not take into consideration the possibility that they have intentionally distorted their data/papers because if I applied possibility to SoniModul, I would have to apply that to every healthcare professional in which case, I would not ever see a doctor for anything.

Accepting what they say their website to be accurate;

Noninvasive.

No significant deficits have occurred.

No significant side effects have occurred.

Doctors at SoniModul believe the benefits will, at minimum, last many years and possibly indefinitely.

Every anecdote of those with first-hand knowledge are extremely positive.

True, there is no guarantee how long the benefits will last.

True, there is no guarantee that lesioning won’t preclude a future therapy.

True, there is no guarantee against deficits or side effects.

Bottom line, Parkinson’s is the shits and not one single thing in my entire life came with a guarantee.

I really don't care about your "why". I never asked for it. I am interested in assessing the clinical validity of a non-random, unmasked surgical intervention. Nothing more.

I know you did not ask why, but l felt it relevant because it feels like you're questioning the wisdom of having PTT because the outcomes are not valid by accepted standards. I shared my reasoning with you because I don't feel I (or any of us) have the luxury of basing decisions exclusively on the scientific validity of outcomes.

I don't think anything I do, except exercise, meets such standards nor will anything I ever do.

I would love nothing more than to be in a position where I did not have to act or make a decision unless the scientific validity was beyond question.

This explains why anecdotes of other people's experience is more valuable to us than for others. There is precious little else for us to go on.

" because I don't feel I (or any of us) have the luxury of basing decisions exclusively on the scientific validity of outcomes."

"exclusively" isn't the operative word in our discussion. NEVER was,

So, let's get right to the heart of the matter.

Do you think it foolish for some of us to have FUS PTT -- as a yes or no question?

For one thing call it by the correct name ....the Swiss MR-guided focused ultrasound (MRgFUS) technique.

It is your choice to do it or not. I don't care if you did or didn't, but don't start a religion over a partially positive experience. And we still don't know what your effects will be long term.

As I have repeatedly said, a lot of this sounds like a replay of DBS 10 years ago before reality set in.

At no time have I done anything but answer people's questions. I am enthusiastic about my own experience and I am excited about my upcoming opportunity, but I don't ever make recommendations. I only say what I do and why.

As I re read your every remark, one can only conclude you think it's unwise. I respect that belief. I agree there is justification for it.

MBA said...."unless the scientific validity was beyond question."

In my experience, it seldom is beyond question, very seldom.

MBA said...."This explains why anecdotes of other people's experience is more valuable to us than for others. There is precious little else for us to go on."

As a clinical trials specialist who is involved with stage 3 and 4 cancer patients (whose mortality rates are light years higher than PD) I don't have that luxury of relying on "personal" anecdotes as transferable to a general population. I am not saying they are irrelevant in context, but that context is not relevant to what I do as a professional. The singular interventions by Dr. H and his amino acid theories, as good as it may be, is simply too singular to be deployed except by a very small group of physicians in a very narrow context.

This difference in perspectives is exactly why most of the "hate mail regulars" never get where I am coming from, which is also why all these zillion microbiology cell studies never make it to the drawing board. They are way, way too narrow.

Sharon

I agree in that we do not want doctors prescribing potions for cancer or anything that doesn't meet the scientific evidence standard. I don't think it's a good analogy.

ChrisWF
ChrisWF in reply to sharoncrayn

"This difference in perspectives is exactly why most of the "hate mail regulars" never get where I am coming from"

The "hate mail regulars" get where you are coming from, they just take issue with your tone. Quit acting like the only way to deliver the information is with the bitchy tone that you insist on. It is absolutely something you choose to do.

You are rude and condascending. It has nothing to do with your "perspective".

When jimcaster, who is a very measured guy, is calling you out, it might be time to actually have a look at your conduct rather than double down on your existing approach.

Ms. Crayon,

The problem with your critique above, which essentially, is that they omitted certain segments of time and and thereby cherry pick the cases -- is the word "consecutive" as in,"... 51 consecutive cases..."

In this context, the word consecutive means no cherry picking occurred.

Your critiques aren't bad, but they would be much better if you did not cherry pick the words you choose to exclude.

You don't even understand his use of term "consecutive" in their case study as in "This consecutive case series reflects our current treatment routine".

FYI, he is referring to his use of the same protocol or intervention technique. It had nothing to do with "segments of time" per se as you state.

I NEVER implied " that they omitted certain segments of time and and thereby cherry pick the cases" . Your words as usual,not mine. Read and understand what I wrote. Understand these cases (all of them) were non-random and unmasked. which by definition means they can pick and choose....which they obviously did!

They did so to maximize their chances of success. If that population is extremely small, which it probably is, then PTT FUS has limited applicability to the general PD population.

FINIS

Sharon

pdpatient
pdpatient in reply to Trixiedee

WOW, Trixiedee. Exactly my thoughts. Please read my post about Sharon's behavior in this group.

Ya think it's time for an excommunication?

"excommunicaton'?

Wow. Is this forum becoming a cult where a voice with a different perspective must be silenced. If you are so concerned about my posts, just don't read them.

Parkie-
Parkie- in reply to sharoncrayn

"The benefits won't last"

That’s quite a statement... what scientific data is your statement based on?

And like MBA asked "what is the extension"?

sharoncrayn
sharoncrayn in reply to Parkie-

read my answer

sharoncrayn
sharoncrayn in reply to Parkie-

read the case study

Parkie-
Parkie- in reply to sharoncrayn

I read the case study, thank you.

Now, concerning your statement :

"The benefits won't last"

What scientific data is your statement based on?

sharoncrayn
sharoncrayn in reply to Parkie-

Look at their data, which does not address the issue of longevity, and their need to revise their protocol/intervention, which specifically is the MR-guided focused ultrasound (MRgFUS) technique going back to 2011. Not some other technique.

"This intervention, the pallidothalamic tractotomy (PTT), has been performed since 2011 using the MR-guided focused ultrasound (MRgFUS) technique. A reappraisal of the histology of the pallidothalamic tract was combined recently with an optimization of our lesioning strategy using thermal dose control." They changed it for a reason.

luba1
luba1 in reply to lenamm

Sorry, what is PTT, thanks

lenamm
lenamm in reply to luba1

Pallidothalamic tractotomy - it is a lesioning surgery done by focused ultrasound

beehive23
beehive23 in reply to ChrisWF

brace yourselves now that dementia and pd are in the headlines anything you say or do that someone doesnt like we will be blamed because of pd. pd bias just took a big leap for the worse.

Sapeye2020
Sapeye2020 in reply to beehive23

I don't follow you, can you think of a theoretical example or even a real one ?

beehive23
beehive23 in reply to Sapeye2020

yes....many...

Good more recent interview.

youtube.com/watch?v=0e90Iia...

What is fusi,is this something you get in the usa

lenamm
lenamm in reply to Tilly56

Focused ultrasound is a tool - it is a way of directing focused ultrasound with MRI visualization. It can be used for many surgeries all with different outcomes. To talk about FUS without naming the surgery tells nothing, it is like saying a doctor used a scalpel without naming the surgery.Focused ultrasound is a way to do surgery. You are permenantly destroying a part of the brain. It is something to consider vs DBS. It is not done with early disease. It is brain surgery we are talking about. No incision is needed and side effects are rare but there is risk.

There are three surgeries for Parkinson's. PTT (pallidothalamic tractotomy) in Switzerland is the only one that can be done on both sides and treats tremor, dystonia, dyskinesia, bradykinesis and rigidity and results hold for at least six years (ie halts progression of symptoms). Thalmotomy in the US and other countries is just for tremor dominant PD and is FDA approved and can only be done on one side. Pallidiotomy is US is for dyskinesia and is in trials in the US, Canada, maybe UK but seems to treat different symptoms as well, also only one side can be done. I have less info on the surgeries besides PTT since I did not go through them. At this point only medication resistant folks qualify for FUS surgeries

sharoncrayn
sharoncrayn in reply to lenamm

"results hold for at least six years (ie halts progression of symptoms). " So you know that as a fact? Who is telling you that? I thought Gallway only did a 1 year follow up in both of his case studies. I guess I was mistaken.

Sharon

ChrisWF
ChrisWF in reply to sharoncrayn

Jeanmonod, probably.

It's difficult to assess these claims from the outside looking in.

What i find a bit strange is that he has been doing the procedure since 2011 but only speaks to 6 years. What about the people from 2011 through 2013? I appreciate there wouldnt me many of them, but their status would be interesting to both the doctor and his patients.

ion_ion
ion_ion in reply to ChrisWF

This is a good point which I missed to ask the dr. during the conversation I had with him. So regarding the effectiveness of the FUS is said on their site it can last for ever through analogy with DBS but they had monitored patients starting 6 years ago; you are right, what about those who had it in 2011? What about those who had the classical surgery procedure in nineties!?

rescuema
rescuema in reply to ion_ion

I'm not sure if they can draw a prediction based on an analogy with DBS although that may be the case.

DBS was assumed to stop, slow, or last up to 5 years, ...and what's said has been changing with time and more data. The latest is that DBS is "likely to decrease the risk of progression" only if implanted in the very earliest stages while using considerably less of the medication used to manage symptoms of Parkinson’s.

parkinsonsnewstoday.com/202...

technologynetworks.com/neur...

I have not been able to find where the "6 years" PTT FUS data was extrapolated from, or assume it may stop progression especially when they probably have not tried this for early stage Parkinsons.

Kwinholt
Kwinholt in reply to sharoncrayn

Sharon, I am 57 years old and going on 8 years diagnosed with PD and just at my last appt with my dr he suggested me to think about DBS. I know a few people that have had it done and I am doing research and going to classes , DBS support groups to hear their experiences . I can’t afford to go to Switzerland for FUS, but quite frankly DBS scares the hell out of me. I was wondering in your groups and research , what thoughts you have on DBS? Just looking for all different sides of the debate. Thank you . Karen

sharoncrayn
sharoncrayn in reply to Kwinholt

Kwin,

I am not against FUS or DBS, but its application us relatively limited. Neither is either a "universal solution." Be realistic.

If you are serious about doing DBS, set up a consult at Mayo (1st choice), Cleveland, or Hopkins. They will tell yes or no. If Mayo says "no"...drop it...don't shop for a yes.

At Mayo, or wherever, select the team with the most total DBS interventions...and at least 300 per year. You want experience.

Sharon

Kwinholt
Kwinholt in reply to sharoncrayn

Sharon, Thank you for your in put , I appreciate it. I am in California and will continue more research locally. Karen

sharoncrayn
sharoncrayn in reply to Kwinholt

Good luck with your decision. It is a difficult one.

What is FUS?

Focused Ultrasound Surgery.

Using ultrasound to heat targeted brain cells to destroy or denature them.

he had sterotactic ablation ...gamma knife....disqualifies for dbs.

2 days ago

youtube.com/watch?v=_Ee00HA...

I was told by my motion disease specialist /neurologist /head of brain surgery in Toronto Hospital that DBS was not available to me because it had been decided it was too dangerous, with a very small effect . I have observed that the quantity of DBS operations is geographical , which could mean that some hospitals have developed certain skill sets that others can not duplicate .

I use the following example to show that something else may be happening.

Trepanation is perhaps the oldest surgical procedure for which there is archaeological evidence, in the forms of cave paintings and human remains. Many prehistoric and pre-modern and more recent patients had signs of their skull structure healing, suggesting that many of those subjected to the surgery survived.

More than 1,500 trephined skulls from the Neolithic period (representing 5 to 10% of all Stone Age skulls) have been uncovered throughout the world . This practice carried on until the early 20 th century. How could that many operations happen without some one saying that it helped them.

If you examine the reports of DBS in Health Unlocked you will find that there have been successes and you will see much praise for the procedure but (always a but)there are several examples of people saying they are going into surgery tomorrow , never to be heard from again and reports of serious problems and often no follow up on the success.

Marc,with the greatest admiration for your courage. The determination of success and quantification of improvement should come from a third party through a scientific evaluation not from you. Why ? If one person was lead into surgery by your enthusiasm and suffered consequence. I do not feel comfortable with your apparent understanding of what Sharon Crayn is saying and why. It is unfortunate that Sharon speaks in a tone that could be considered adversarial because she may be right.

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