I also posted this in response to jeanb's thread. I thought it was important enough to flag as a new thread. Apologies to those who are reading it twice!

The Northwest Parkinson's Foundation publishes a bimonthly Parkinson's Post, a digest of articles. In the September 11 issue there is an article entitled Consenting after the Fact? about a clinical trial of DBS for early stage PD. Here is an excerpt:

Consenting After the Fact?

I got this mailing from my friends at the Neurology Department at Vanderbilt University Medical Center a couple weeks ago. It was another revision in the standard consent form they keep on file for the clinical trial in which I’m involved — a Phase I trial of deep brain stimulation in early Parkinson’s disease.

If I remember correctly, there have been a couple of these since I joined the trial in 2007. Pretty routine stuff — look it over, sign it if you agree, mail it back. So I didn’t really rush to deal with the one I got a couple weeks ago.

Today, Gail is having a house dusting extravaganza. Anything not moving WILL be dusted! Anything not where it is supposed to be WILL be put WHERE it is supposed to be. One such item was the large manila envelope with the consent form update. So, I decided to take a look at it — finally.

Here’s the update: (emphasis added)

“The following sentence was added: ‘It is also possible that the use of DBS in early stage PD may speed up progression of the disease and may make you ineligible in the future for the FDA-approved DBS for advanced PD.”

[The writer goes on to say s/he would have still joined the trial had the update been part of the original consent form. For full text, here's a link: http://www.nwpf.org/News.aspx?Item=3019 ]

This "update" seems like pretty big news to me. Speed up progression? Make you ineligible for DBS in the future? Yikes.

Something must have happened to make the researchers add these risks to the informed consent retroactively. Does anybody know anything about these risks of DBS in early stage PD?

Kathleen

Kathleen,

I hadn't heard anything about early DBS possibly speeding progression. It seems to me that you are owed a complete explanation.

Jean