David Charles, MD, talks about the progress researchers at Vanderbilt University are making in the treatment of Parkinson’s disease and their efforts using deep brain stimulation in attempt to slow the progression of the disease.
Interview conducted by Ivanhoe Broadcast News in January 2019.
First of all, tell us about your trial.
Dr. Charles: Here at Vanderbilt University, we’re very interested in the treatment of deep brain stimulation for patients with very, very early stage Parkinson’s disease. So our effort is to see if applying deep brain stimulation early might slow the progression of the disease.
What did you specifically look at during the trial?
Dr. Charles: We looked at all elements of Parkinson’s disease and also cognitive function. But one of the really interesting findings that has just come forward is that it looks like DBS supplied in the very earliest stages of Parkinson’s disease may slow the progression of tremor.
What do the participants do during the trial?
Dr. Charles: The participants are admitted to Vanderbilt’s clinical research center. On the first day they were evaluated on their Parkinson’s treatments. And at the end of that day, they stopped treatment and then washed out of all their Parkinson’s therapies over the course of a week.
Walk me through the DBS procedure.
Dr. Charles: The deep brain stimulation procedure is a surgical procedure to implant electrodes in an area of the brain called the subthalamic nucleus. We have two; a left one and a right one, so two electrodes are implanted. They are then connected to a pulse generator, much like a cardiac pacemaker, that gives a tiny electrical stimulus to the brain, helping improve the symptoms of Parkinson’s disease.
How long is the procedure?
Dr. Charles: Typically the procedure takes about two or three hours to complete.
Why was it necessary for Parkinson’s patients to be off their medications for this specific time?
Dr. Charles: One of the things about Parkinson’s Disease is it’s relentlessly progressive in every case and all of the therapies that we currently have available do not change the progression of the disease, they simply help the symptoms. What we found here was that deep brain stimulation applied in the earliest stages of Parkinson’s disease appear to possibly be slowing the progression of tremor, and that, if it’s proven in a large scale trial, would be a landmark achievement in Parkinson’s disease because, to date, we have no therapies that slow the progression of any element of the disease.
So them being off their medications, you could truly understand just how it was beneficial or how it helped?
Dr. Charles: Right. The reason for taking the patients off their medication through this initial trial here at Vanderbilt was to be able to evaluate them in the fully untreated state to really get a picture of what their underlying Parkinson’s disease was doing over time, to measure progression.
Is it different from patient to patient in terms of Parkinson’s itself and how it affects somebody and impacts them?
Dr. Charles: Yeah, most definitely. Parkinson’s disease can be variable from patient to patient. Some people seem to progress rather slowly, some are more typical, and others may unfortunately progress more rapidly. But the one thing we do know is that it’s relentlessly progressive in every case.
Can you explain what the findings of this specific trial were?
Dr. Charles: The reason these findings are so interesting is because it may be the first sign that we have a therapy that could slow the progression of an element of the disease. What was found here is that people who were treated with optimal medical therapy were nearly threefold more likely to develop worsening of their tremor over the course of the study. In fact, the patients that received optimal medical therapy were seven times more likely to have tremor develop in an additional body segment over the course of the study compared to those that received DBS.
For patients who do undergo DBS; is it just one time, and then they don’t need it again?
Dr. Charles: Yeah. The main procedure for DBS is done primarily once. Subsequently after that, every few years a battery replacement is necessary, that’s just a minor outpatient procedure to just exchange the battery. But otherwise the therapy is a one-time operation.
What kind of implications does the trial have for future therapies?
Dr. Charles: Vanderbilt University, our team here, has been approved to conduct a large-scale Phase 3 pivotal clinical trial in over 280 patients across 18 centers here in the United States. It’s this definitive trial that’s really needed to determine if deep brain stimulation applied in the earliest stages of Parkinson’s disease may slow its progression or slow the progression of tremor.
What are the advantages and disadvantages of DBS vs. other treatments for Parkinson’s?
Dr. Charles: Well the main disadvantage is that it’s a surgical procedure. The idea of brain surgery can be quite frightening to anyone. The main advantages would be that it’s adjustable, it can be adjusted upward, downward, it can even be turned off or even removed if necessary. What’s different here and what’s so exciting about this finding is that DBS applied early may slow the progression of tremor, where today, we have no therapies that slow any element of Parkinson’s disease.
Why would DBS be approved for late stage Parkinson’s but not early stage?
Dr. Charles: The main reason that DBS so far has been approved for advanced stage Parkinson’s disease, more recently mid stage Parkinson’s disease, and not early is that it hasn’t been adequately studied in early stage disease yet. So therein lies the reason that the FDA has approved this large-scale pivotal trial that we intend to lead here at Vanderbilt.
What are the next steps for this specific research?
Dr. Charles: The next step is the conduct of this large scale Phase 3 pivotal clinical trial. That’ll be two hundred eighty patients across 18 U.S. centers.
When does that start?
Dr. Charles: The beginning of that new trial will be in 2019.
What is the eligibility criteria for someone who wants to take part in the new trial?
Dr. Charles: The eligibility criteria for the new Parkinson’s study are people aged 50 to 75, who’ve had Parkinson’s disease between 1 and 4 years, and who have a stable response to their medication.
Where can someone go to get more information about the upcoming trial in 2019?
Dr. Charles: People who are interested in contacting us about this study can call 615-343-2961 here at Vanderbilt University Medical Center.
What can this research mean for someone who is battling Parkinson’s?
Dr. Charles: I think the main message from this research is to know that there are people who are dedicated to doing research in the field of Parkinson’s disease to bring better treatments. We haven’t learned enough from this initial finding to change the way patients are currently treated. What we have is a really exciting finding that means that we have to conduct this next
Anything else you would want to add that you think people should know, whether it be about this current trial or you know the work that you’re going to be doing in the future?
Dr. Charles: Vanderbilt’s the best medical center in the nation!
END OF INTERVIEW
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