FDA Approves Scalpel-Free Parkinson Treat... - Cure Parkinson's
FDA Approves Scalpel-Free Parkinson Treatment Approved
Seems to me, this is pretty significant? Reduces tremor by 62% and reduces other symptoms, as well.
Always also consider the adverse events:
"Heating of the internal capsule resulted in 2 cases (8%) of mild hemiparesis early in the study; however, these cases improved and resulted in the monitoring of an additional axis during magnetic resonance thermometry. Orofacial paresthesia (4 events [20%]), finger paresthesia (1 event [5%]), and ataxia (1 event [5%]) included other persistent adverse events."
I noted those event percents. Excluding finger paresthesia, there's about a 10% chance of an adverse event, none of which sound fun.
That leaves a 90% chance of achieving a 62% reduction in tremor and improvement in other symptoms is pretty attractive.
What is your thinking?
PS. This Is another one that snuck/sneaked up on me, i.e., I haven't seen publish phase 3 trials.
I don't see how that happens with Iqbaliqbal standing watch.
If someone is has got out of control tremors not remedied by medication it is worth consideration. No risk of infection, unlike DBS.
Your description is an explicit inclusion criteria to be in such a FUS trial. Which excludes me.
Apparently, the only location in North America is Calgary and Toronto.
There are eight treatment centers in the US currently involved in clinical trials for PD. There are 11 treatment centers offering commercial treatment for essential tremor. I would guess that within a relatively short time some or all of the eight treatment centers in the PD trials are going to offer commercial treatment for PD tremor. Go to fusfoundation.org for the locations. Baltimore has, by far, the most experience with the technology.
Julie, since it has already been approved by the FDA, they already have the data, why are they running trials?
Julie, thank you for that link. I went to their website and on 1 of the landing pages it recognize FDA approval, but when I got to the Baltimore location the content was dated February 2018 at which time he said they were in phase 3. So, perhaps they are out of trials now? You've obviously looked at this extensively, so are you interested in it?
I was patient #5 in the dyskinesia trial which is still ongoing. The procedure targets a different location for dyskinesia which has not been approved.
How did you do after the FUS Juliegrace? I don’t have a tremor, just rigidity and bradykinesia as well as dyskinesia. I’m thinking of going to Switzerland as I live in the UK. Did they treat both sides of your brain?
They only did one side. It was a mixed response for me. Short term it really improved things but the improvements didn't sustain. I think I needed a bigger lesion, but they erred on the side of caution (which is good).
Julie,
That FUS only works on one site is new to me. Do you know if they do both sites in Switzerland? It sounds like that means the other side is completely unaffected? Have you already told us how you're doing in the trial and I missed it or can't remember? Are any other symptoms beyond tremor affected?
Thank you.
Marc
The protocol for the study was only for one side. I don't know if commercially anyone does both sides at once or separately. I did not have it done for tremor. I had a different procedure for dyskinesia so I can't answer any questions about tremor.
Thank you, thank you.
It has been practised in Switzerland at this place for years. They use a different method from the one described. It has worked well for two people I know of. Another is having the treatment in April.
Thank you for this. Their method seems to make more sense. They been doing this in Israel and Korea for many years, too. Maybe that's why they have a lower adverse event frequency.
This link was inside your link. They explain Parkinson's differently then US pharmaceutical companies.
"The results ... can be summarized as follows: mean symptom relief covering all symptoms as listed in the Unified Parkinson Disease Rating Scale (UPDRS) was between 50 and 60%, the mean improvement of quality of life 67%. Half the patients could stop their drug intake."
sonimodul.ch/wp-content/upl...
PS. "The symptom improvements were stable over 5 years, an observation
which allows to question a most active dogma in this field: the impossibility to
stop the disease progression. We may now interpret that former studies and
approaches, particularly with Deep Brain Stimulation (DBS), were not in
position to liberate the thalamocortical network well enough to prevent the
maintenance/progression of the parkinsonian TCD."
I know one of the women who had both sides treated in Switzerland with excellent results but her speech has been badly affected. She’s really happy though. I’d love to have this done. I believe it’s about 30k USD though sadly
I know her too. Michelle?
I know her too where did you get 30k from
Where did she get it? Crowdfunding.
I don't know her personally. I saw a video of her on Dr Laurie Mischley FBpage that her daughter had made. I then private messaged her daughter Summer on FB to ask her more about her Mums surgery, and she told me she was very happy, but her speech affected with bad mumbling. 30k is what Ramban hospital in Israel quoted me by email.
Yes I’m pretty sure it was about £30k in Switzerland too.
$30,000! Boo-hoo.
Not a different method, the same method originally developed by InSightec (ExAblate, ExAblate Neuro): insightec.com/ SoniModul was among the first to receive certification to offer treatment at their center there in Switzerland however: sonimodul.ch/sonimodul-the-... SoniModul's Dr. Daniel Jeanmonod also does decent job of explaining the bio-mechanics/procedure: youtu.be/auhVhEQlSLc
They are targeting a slightly different area of the brain in Switzerland but with the same equipment.
The PTT (pallidothalamic tractotomy) is the ONLY viable 'target'.
Similar technology is now being used to treat Essential Tremor in Australia.
The Australian guy had to pay $30k (Aus) as it’s not covered by the gov yet.
Another friend has just had the procedure in Switzerland. She’s amazed with the results.
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