Debi,

A question for you & the scientists at MJFOX:

I would like to know if the people who received sham surgery in the Ceregene trial had the same degree of physical reaction to brain surgery as the people who had invasive brain surgery?

For example, if everyone had some degree of facial swelling, was it markedly more severe for those who received the gene therapy treatment than for those who got the sham surgery?

I ask because it simply doesn't seem logical that patients who received invasive gene therapy surgery would display the exact same physical reactions as those in the sham surgery, where they drill the hole, but don't penetrate the dura.

And if this is true, then sham surgery isn't truly "blind."

thanks,

AMA (Jan. 2009) -- " Bilateral Deep Brain Stimulation vs Best Medical Therapy for Patients With Advanced Parkinson Disease: A Randomized Controlled Trial"

The DBS study compared participants who had received DBS surgery with the best managed care by movement disorders specialists.

Only the raters were blinded -- " To ensure blinded assessments during follow-up, all patients wore caps to cover evidence of possible cranial surgery and clothing to cover any incision for the neurostimulator. "

Why was this method ok to use for DBS? Why is sham surgery being touted as best for gene therapy trials when the DBS trial was successfully run without using sham surgery?

I missed this particular post but essentially tried to address this question and others in another thread...."Questions about neurosurgery & sham surgery"

Debi

Thank you so much for your posts!

Jean B
www.pdplan4life.com