Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson’s Disease

[Farooqji]

TAmong 40 enrolled patients, 27 were assigned to focused ultrasound subthalamotomy (active treatment) and 13 to the sham procedure (control). The mean MDS-UPDRS III score for the more affected side decreased from 19.9 at baseline to 9.9 at 4 months in the active-treatment group (least-squares mean difference, 9.8 points; 95% confidence interval [CI], 8.6 to 11.1) and from 18.7 to 17.1 in the control group (least-squares mean difference, 1.7 points; 95% CI, 0.0 to 3.5); the between-group difference was 8.1 points (95% CI, 6.0 to 10.3; P<0.001). Adverse events in the active-treatment group were dyskinesia in the off-medication state in 6 patients and in the on-medication state in 6, which persisted in 3 and 1, respectively, at 4 months; weakness on the treated side in 5 patients, which persisted in 2 at 4 months; speech disturbance in 15 patients, which persisted in 3 at 4 months; facial weakness in 3 patients, which persisted in 1 at 4 months; and gait disturbance in 13 patients, which persisted in 2 at 4 months. In 6 patients in the active-treatment group, some of these deficits were present at 12 months.

CONCLUSIONS

Focused ultrasound subthalamotomy in one hemisphere improved motor features of Parkinson’s disease in selected patients with asymmetric signs. Adverse events included speech and gait disturbances, weakness on the treated side, and dyskinesia. (Funded by Insightec and others; ClinicalTrials.gov number,

nejm.org/doi/full/10.1056/N...

[Xenos]

Thank you for pointing this paper, but do we know the difference between subthalamotomy and PTT (palido-thalamic tractotomy) ? Or is it the same thing ?

[MBAnderson in reply to Xenos]

Different targeted areas.

[Xenos in reply to MBAnderson]

😅 Thank you MBA, such a relief...

[MBAnderson]

1st go through, I missed the supplemental index. So I am withholding/withdrawing my comment until I have studied it.

[Parkie- in reply to MBAnderson]

"How precisely do they know where control of speech leaves off and control of gait begins?"

I don't know how they determine the area but Dr J tests area prior making each sonication permanent, thus avoiding permanent adverse effects:

"Target is first exposed to low temperatures, producing reversible effects and allowing to determine the precise centering of the thermal rise. The target temperature is then increased progressively up to the final temperature between 55 and 60°."

[MBAnderson in reply to Parkie-]

Thank you for this, Parkie. I had forgotten about them testing the location 1st.

[lenamm]

I agree with you Marc - the side effects are way worse with this than PTT. I have some very mild speech issues from side two. Everything else is just good, good, good. Gait is way way better! Zero dyskinesia anymore!

[Parkie- in reply to lenamm]

Hi Lena

Can you describe the speech issues?

Thank you

[lenamm in reply to Parkie-]

My voice is a little quieter and by the end of the evening when I am tired my words get tangled. In the grand scheme of things a small price to pay for being able to walk, sit-in comfort and feel almost like a normal person. Dr. G suggested I do some Big and Loud therapy for it.

[Parkie- in reply to lenamm]

I have alot of different speech issues depending if "on" or "off" and "over medicated". I wonder if ptt will help or worsen these... Did you (or anyone else who had ptt) had speech issues before the surgery?

[lenamm in reply to Parkie-]

I had mild issues before my surgery. Part of the issue I think is that the rigidity in my tongue is gone (A good thing but takes some adjustment. ) PTT tends to not help speech issues and in bilateral can make them slightly worse yet even the woman who had bilateral at the same time and it effected her speech is overjoyed with results.

[ion_ion in reply to lenamm]

Hi Lena!

Do you think the one year interval between the two procedures made this side effect weaker than if the procedures were done the same time? Has the therapy the doctor recommended any chance to repair this side effect. I agree this negative is small compared with the positives as long as you are still able to communicate.

[lenamm in reply to ion_ion]

I am still able to communicate fine. My understanding is they do not do both sides at once anymore.

[ion_ion in reply to lenamm]

I know they do not do both sides the same time and I was wondering if longer the interval between the procedures means lesser chances of speech side effects. Dr. Jeanmonod should have an answer if that is true and if so, why.

When I'll see him I'll compile a list of questions with the help of people from this forum.

Thank you.

[lenamm in reply to ion_ion]

My voice is already improving so it seems to be a temporary effect. Yes it is safe to do at least a year apart but sure if longer than that makes a difference.

[Parkie- in reply to lenamm]

My thought when I read the abstract was that it's a shame they are damaging pwp with these clinical trials while a successful procedure is published and available for everyone to see... And Dr J and Dr G would be more than happy to share as they did with the Japanese.,.

[sharoncrayn in reply to Parkie-]

Parkie,

Can you post that successful published CT by Drs. J and G and also their Japanese communication? Thanks.

Sharon

[sharoncrayn in reply to Parkie-]

Parki,

I assume you are referring to this Japanese case study...

"His work builds on previous research by renowned Swiss clinician Daniel Jeanmonod, MD. In the current study, Prof. Taira plans to treat 10 patients using Insightec’s Exablate Neuro device. As with other focused ultrasound studies for Parkinson’s disease, he will treat unilaterally, meaning he will only treat one side of the brain. Typically this is the side of the brain that controls the patient’s dominant side. . "

Why don't your write him and report back? Must be some differences.

Sharon

[Parkie- in reply to sharoncrayn]

I am not your employee, if you want to ask something, do it yourself.

[sharoncrayn in reply to Parkie-]

I assumed you were interested in understanding the differences. Obviously not. Sorry for even suggesting it. Perhaps someone else is interested enough to do it.

[GymBag]

I know that what I am about to say will cause great consternation with people pointing out it is not the same thing that I am talking about. I know that.

27 people underwent the procedure so it must be safe.

Lobotomy was legally practiced in controlled and regulated U.S. centers and in Finland, Sweden, the United Kingdom, Spain, India, Belgium and the Netherlands. The practice had generally ceased by the early 1970s, but some countries continued small-scale operations through the late 1980s. In France, 32 lobotomies were performed between 1980 and 1986 according to an IGAS report; about 15 each year in the UK, 70 in Belgium, and about 15 for the Massachusetts General Hospital of Boston

Lobotomy was most prevalent in the United States, with approximately 40,000 persons lobotomized, followed by Great Britain with approximately 17,000 and the three Scandinavian countries with a combined figure of approximately 9,300.

Trepanation is somewhat akin to the practice of blood letting except they drilled 3 holes in your head. My Great great great grandmother had Parkinsons and was Trepanned with the result of loss of mental capacity and most movement. Many thousands of people have received this now banned treatment.

A few years ago a doctor in California operated on a blood vessel in the back of his wifes neck freeing her from a terrible deseace and people all over the world lined up and raised money to send people there for the treatment.

How did so many procedures get done on real people without a real single successful outcome?

[pdpatient in reply to GymBag]

Gymbag, I once listened to a NPR program on the topic of lobotomy and it's wide use previously, in fact till recently. The program was excellent with very good work by the reporter.

I was very horrified by the graphic description of the procedure by a doctor who was interviewed and I was filled with mixed feelings of disbelief, anger, loathing and pity.

I think lobotomy is a barbaric procedure, unworthy of these "modern times".

[MarionP in reply to GymBag]

What\who was the neck procedue, that doctor did on his wife so I can look it up?

[Trixiedee in reply to GymBag]

I know of someone in the UK who trepanned herself and she is sharp as a tack and has no physical side effects. She doesn’t have Parkinson’s. Comparing lobotomy to FUS is really insulting. I don’t know anyone who has had FUS who has impaired mental functioning.

[Routine100]

I did research on the history of success in treating PD with this procedure. Many years ago maybe more than 50 a Doctor performed this procedure and it was very successful. This was done by a surgeon and most surgeons did not have the knowledge or skill to perform this treatment.

The drug companies along with many Doctors buried this procedure and replaced it with what they call medication. A person can easily find evidence showing what the result is for a PD person taking the prescribed drugs for long term treatment.

Today we have advanced technology FUS developed by an Israeli company insightec treatment is only offered in Israel to a select few and is not promoted by the health ministry.

A clinic in Switzerland offers this treatment for $38,000 a lot of money for most people.

The US government is giving away billions of dollars to other countries and for projects that are not helping US citizens. Make this procedure affordable help all those suffering and cut the chains big pharmaceutical have on the life of millions worldwide.

[MarionP in reply to Routine100]

"I did research on the history of success in treating PD with this procedure. "

WHICH procedure please, NAME it. the indefinite articles are flipping around big time right now, I can't keep track of which one each person is talking about. Gym bag and 100 can you specify the procedure names you were talking about it various points please

Also, you mentioned a second procedure that was competitively buried (xcatch and kill") but what was its name, can you say anymore?

[Routine100 in reply to MarionP]

The procedure is called Thalamotomy for movement also Pallidotomy not lobotomy . This can be done using FUS Mir much improved non-invasive. Today the risk is same as any another procedure maybe less. Google Oxford University Hospital Department of Neurological hospital. I do not know if they offer FUS.

[sharoncrayn in reply to MarionP]

MP,

It's technical name is MRgFUS Pallidothalamic Tractotomy.

Since 2010 they have done 360+ "interventions" through various iterations/variations. One published case study on 51 cases.

Sharon

[JANVAN]

Hi, my neurologist gave me this prospect about the 3th annual meeting of SMDS in Switzerland...unfortunately I didn't manage to be there, but nice to see, that something is going on.......

[Routine100]

This procedure is being suppressed because it would change the way medicine is practiced not just for Pd but many other life threatening conditions. This procedure is used in Europe to replace surgery lot's of Doctors and hospitals would lose money if it replaced surgery. The clinic charging $38,000 is run Dr Daniel Jeanmond Center for Ultrasound Functional Neurosurgery (Solothurn Switzerland).

[b-bobble in reply to Routine100]

thank you.

[Routine100 in reply to b-bobble]

I responded to your post a reference you made in the first sentence I did not understand. I was attempting to clarify and was censored this was an insult to me and 75 million plus other people. Why should this happen I spoke the truth this can not be censored really not surprised.

[Farooqji]

Ultrasound Ablation for PD: Benefit Limited by Adverse Effectsmedscape.com/viewarticle/94...