We need to move more quickly to focused u... - Cure Parkinson's

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We need to move more quickly to focused ultrasound (FUS)

jack-edmonston profile image
17 Replies

About half a century ago, the merrRAdical profession established carbidopa/levodopa as the standard treatment for Parkinson’s disease; and it has been so ever since. But replacing dopamine is not a cure, does not always work, and can lose effectiveness over time.

Research went on in many areas, and a search for surgical treatments for Parkinson’s produced deep brain stimulation (DBS), which was granted approval by the US Food and Drug Administration (FDA) in 2002. Since then, according to a publication of the Sage Social Studies of Science, DBS, which uses a pacemaker-like device to deliver constant electrical stimulation to areas within the brain, has been used to treat over 40,000 people with PD and Essential Tremor worldwide.

Heralded as providing ‘a new life for people with Parkinson’s’ (Chou et al., 2012), DBS therapy has become the subject of considerable hope. Stories of previously housebound patients with debilitating symptoms subsequently regaining independence and self-confidence with DBS are not uncommon, and the media has tended to portray the therapy in very optimistic terms (Gilbert and Ovadia, 2011; Racine et al., 2007).

DBS however has its own set of difficulties. It is major surgery, requiring two holes in the head the size of quarters, insertion of leads into the brain, stringing of wires under the skin down into the chest to connect to a battery, and a controller which usually has to be reprogrammed often to make it work properly.

Surgical research continued, and, in 2013, Professor Jeanmonod of the SoniModul Clinic in Switzerland (Sonimodul.ch) started using a new technology called Focused Ultrasound (FUS) to treat brain disorders, including Essential Tremor and Parkinson’s.

Their record since than has included 360 FUS procedures, according to their website. Of those, there were no bleeds, 5 had effects on neighboring structures which were partial and transient, and16 had neurological worsenings which were moderate, mostly transient and seen always in the context of preoperative reduced neurological states.

One of the procedures that Jeanmonod developed was pallidothalamic tractotomy (PTT-FUS) for Parkinson’s. About 200 of these have been successfully performed. We’ve heard of only one that was not.

The advantage of this new treatment is that it requires no surgery, no general anesthesia, almost no risk of infection, fewer trips to hospital; and is about one-fifth the cost. But the results are equally to those obtained through DBS, generally around a 60% improvement in systems.

In my opinion, this technique will be the future of surgery in Parkinson’s (and Focused Ultrasound will be used to advance all medicine. But it might be four years before it is licensed for Parkinson’s The U.S. does not accept the Swiss experience as definitive, and the U.S. is starting its own clinical trials this year which could take up to 4 years to complete. Meanwhile, thousands of Parkinson’s patients will have DBS instead.

Perhaps it is time for us to give more credence to the medical establishments of the countries whose medical systems are close to, or better than, ours, especially Western Europe. This could save us a lot of time, money and unnecessary pain.

I propose that the FDA appoint a committee of experts to study the Swiss results and express an opinion on whether they can be used as a basis for a decision. I ask the APDA, the Michael J. Fox Foundation and the Davis Phinney Foundation to endorse this idea and to put some of their own resources into the evaluation.

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17 Replies
MBAnderson profile image
MBAnderson

Well said and I hate being a cold, wet blanket but I feel there is no chance the Swiss results will move the needle any further than it has already moved the process which is, after all, responsible for the trial of 50 pwp now beginning. We, the US, needs to have US doctors demonstrate the same results. I am sure it is a rule of the FDA.

The trials taking place in the US are occurring in 8 locations. How many doctors will be performing the PTT procedure? 8, 12, 16, 32? Will the Swiss team' description of the target mean that US doctors will use/hit the same precise target? My feeble understanding is that the PT (target) is a pathway. If so, could a US team be 1 or 1/2 mm higher or lower on the pathway and still claim to have used the same target?

In other words, some doctors, like every other profession, will be better than other doctors which will muddy the waters and will make the FDA's decision slower. Eventually, MRg FUS PTT will be approved here, perhaps within a few years.

You said the overall improvement is 60%. That is a good expectation for people to have. Some will do a little better.

chartist profile image
chartist in reply to MBAnderson

Hi Marc,

Do you think a 60% improvement is what you got in total from both procedures? Or can you clarify the balance between first and second?

Thank you!

Art

MBAnderson profile image
MBAnderson in reply to chartist

I feel I got 60% - 65% from the 1sr procedure and so far have gotten another 5% - 10% from the 2nd one.

Problem is, the benefits become immediately 'built in' - as normal, so it's hard to imagine what shape I would now be in.

Hikoi profile image
Hikoi in reply to MBAnderson

I agree with what you write. It seems every country does it’s own research, they dont accept the results of other countries as being totally transferable.

Hikoi profile image
Hikoi

focused ultrasound is being researched for over 100 diseases worldwide. While most are in the early stages, commercial treatment is now available in the US for essential tremor, tremor-dominant Parkinson's disease, uterine fibroids, bone metastases, and the prostate, and others are being treated elsewhere.”What I ddont understand is this focus onSwitzerland when there are numerous centres around the world includiing the US. See here

fusfoundation.org

kevowpd profile image
kevowpd in reply to Hikoi

MRgFUS Pallidothalamic Tractotomy for Chronic Therapy-Resistant Parkinson's Disease

Or, more briefly, "PTT", is the procedure undertaken at one clinic in Switzerland. A handful of members here have had that. Maybe 5? Most of them seem pleased to very pleased, and one is a grey area (but didn't look too promising the last I heard). Problem is, it's ~35k Swiss francs per side of your brain plus travelling and staying there twice, so well over 100 large in your money for the full treatment.

There is a trial underway or at least planned in the USA, which is what has been referenced here. There are other types of 'FUS', as FUS really refers to the equipment and not the procedure. Juliegrace can tell you more about those.

I have no difficulty understanding why the Americans want to test it themselves. The Swiss operation, if characterised in trial lingo, would be single center, open label/no placebo, albeit with a high number of participants and evidently good results. If the Americans approved something on that basis that then went bad, people would want blood.

Hikoi profile image
Hikoi in reply to kevowpd

So am I mixing procedures? PTT is different from FUS for parkinsons tremor - right?

kevowpd profile image
kevowpd in reply to Hikoi

Yes, I think so. I believe what you are referring to is:

Unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor.

lenamm profile image
lenamm in reply to Hikoi

PTT is different than thalamotomy used to treat tremor. Calling FUS , FUS is like calling DBS scapel - I prefer the surgery name by FUS, for example PTT by FUS or thalamotomy by FUS. FUS surgeries are still surgeries - I have two 4mm lesions permanently fired in my brain.

Skydome profile image
Skydome in reply to lenamm

Hi Lena, always good to hear your PTT knowledge and experience. Do you agree with the ‘around 60% overall improvement’ assessment for PTT? Thanks!

lenamm profile image
lenamm in reply to Skydome

For me it was about 80% but I was super bad to start. Went from housebound to working again and enjoying a San Francisco vacation with my son. We’ve been walking about 4-5 hours a day which is now doable although I do have a wonky knee tendon I think from years of dystonia.

Skydome profile image
Skydome in reply to lenamm

Amazing!

Trixiedee profile image
Trixiedee

I’m another happy PTT customer. I agree that it should be more freely available.

Skydome profile image
Skydome in reply to Trixiedee

Hi Trixiedee, hope your are continuing to improve. Do you see a need right now to have your other side done?I particularly value your experience as, like you, I don’t have a tremor. Thanks!

Trixiedee profile image
Trixiedee in reply to Skydome

I’m in no hurry to get my second side done. I don’t know anyone who is rigidity dominant who has had both sides done.

Resano profile image
Resano

According to some research, PD would not be caused by a lack of dopamine but of dopaminergic neurons. Dopamine would still be released quite normally in the clefts of the corresponding receptors. Because survivors (1 out of 4) are not adequately modulated by the pineal gland hormones (day/night cycle), they would not be able to make up for the lost activity of the dead ones.

Quote:"But replacing dopamine is not a cure, does not always work..."

NewHope1961 profile image
NewHope1961

Jack, what is basic difference between their procedures and our focused ultrasound clinics here in the US? Thx

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