Update, five weeks after receiving focused ultrasound treatment in a blinded controlled study

[Pitchfixer]

I will learn in mid-April whether I am in the experimental or the placebo arm of the clinical trial in which I'm enrolled at the Stanford University Neuroscience Institute. It has been difficult for me to guess which I'm in because the results of the procedure have been mixed.

As I reported in my post from three days after the procedure (which I had on January 29, or not), there have been several unexpected positive changes, mainly in the restoration of strength, flexibility, and posture in my body. I have been able to walk faster, longer, and without pain, relative to my experience before the procedure. I am able to get up from a sofa or a soft-cushioned chair without the assistance of my arms, in contrast with what I could do prior to the procedure. A friend who is a massage therapist told me last week that there has been a significant decrease in my dyskinesia, so my whole body is more relaxed than it was. The focus of the study I'm in is upon dyskinesia, so from that perspective, the treatment appears to have been successful.

However, with respect to the left hand tremor that has always been the main symptom I've experienced of Parkinson's, the picture has been mixed. During the second week following the procedure, the tremor returned to my left hand ... and for several weeks, it worsened. I had never before been awakened from my sleep by a trembling left hand, but that happened several times. That (along with the complete absence of the side effects from the procedure described by the study staff, such things as headaches, changes in sensory perceptions, and balance issues) has caused me to wonder once again which arm of the study I am in.

I discussed this with the study staff on my one-month follow-up visit to the clinic last week. At that time, I was still experiencing left-hand tremors. One of the neurosurgeons involved in administering my procedure advised me to be patient and said that further changes might occur. And indeed, over the past couple of days, the tremor has disappeared (I have always continued to take the medications prescribed for it, as requested by study staff--carbodopa/levidopa, rasagaline, and pramipexole) and I have felt the best that I have in years.

So from my perspective, the jury is still out on whether I actually received the focused ultrasound procedure, though I am now leaning more toward a 'yes' answer. I'll weigh in following my next clinic visit in mid-April, or sooner if there are significant changes in my condition.

[laglag]

Thanks for updating us. Sounds promising for you. You're a hero to PwP's!

[Xenos]

Thank you so much for sharing

[MBAnderson]

Do you know if it was a pallidotomy or the same procedure they are performing in Solothurn, that is, pallido-thalamic tractotomy (PTT)?

[Pitchfixer in reply to MBAnderson]

No, I don't know ... and the details of the procedure are no longer available to me on Stanford's MyHealth portal.

[MBAnderson in reply to Pitchfixer]

While you were in the MRI machine, I assume they came over and evaluated your tremor and talked to you about it then went back and did another sonication? How many sonication is did you get?

[Pitchfixer]

The website refers to it as an ExAblate Pallidotomy (or a Sham ExAblate Pallidotomy). I had an MRI two days before the procedure. Then I was in the MRI for an hour prior to their doing (or faking) the procedure. For the latter, I was in and out of the MRI seven times, with two sonications during each trip in (and three on one of the trips in) for a total of 15. Each time they rolled me out of the MRI, they checked me for strength and performed some other simple physical tests.

[MBAnderson in reply to Pitchfixer]

Thank you. I'm not going to venture a guess as to whether or not you got the real thing or the sham.

[20fatcats]

Thank you for update and for being willing to try which us encouraging for us all. I wish you well.

[Zella23]

Thanks very much for your post. Really interesting regarding your experience and symptom improvements. Look forward to hearing how you get on. All the best to you - such a positive response.

[JantheNana]

Thank you. Please keep us informed as to your outcome.

[Fighttolivenow]

Thank you for updating and keeping us in the loop. Good luck and all the best to you.

[Sandmanliz]

Keep us in the loop! Thank you so much

[sharoncrayn]

Relevant to PD, but specific to ET: MRgFUS meta in 2017

"The largest study published so far is a multicenter randomized controlled clinical trial study that enrolled 76 ET patients and allocated them to unilateral MRgFUS-thalamotomy or sham surgery with a 3:1 ratio. 32 Hand tremor scores improved by 47% at the 3-month assessment (primary endpoint), a significant difference from patients who received a sham procedure (improved by only 1%).

Notably.....the benefit decreased at the 12-month assessment (40% improvement compared with baseline). Adverse events were commonly reported, including paresthesia and balance disturbances, respectively seen in 14% and 9% of patients at the end of the observation period."

Is the decrease in efficacy longitudinal in the form of a normal declining curve with a stronger taper as it extends out in time?

Sharon

[sharoncrayn in reply to sharoncrayn]

From the 2017 CT: the use of percentages in any analysis is always somewhat deceiving. The "sham " and "real" scores suggest possible (probable) placebo effects.

"Findings In this 2-center, double-blind, sham-controlled, pilot randomized clinical trial of 27 patients with tremor-dominant Parkinson disease, on-medication Clinical Rating Scale for Tremor A+B treated hand tremor subscores improved a median of 7 points (62%) at 3 months following focused ultrasound thalamotomy and 2 points (22%) following sham procedures, a statistically significant difference. Two cases of transient hemiparesis occurred owing to unrecognized capsular heating."

Sharon

[MarionP]

Please update us regularly if you can!!

[Pitchfixer in reply to MarionP]

I'll do my best to report any significant changes as they occur. It's now been seven weeks since I did or did not receive focused ultrasound therapy, and there continue to be improvements in some areas (ease of getting up from soft seat cushions, ease of walking with increased flexibility and endurance) and declines in others (specifically, my intermittent left hand tremor is sometimes worse than it was before the procedure).

I am scheduled for a revisit to Stanford on April 15th and 16th, and the study will be unblinded at that time--that is, I will be told whether they gave me the treatment on January 29th or whether they faked it.

Expect to see an update from me around that time, which is some 4-1/2 weeks off.