Another Research Study

Most readers of this blog will know that the brain surgery that I had last week was done as part of a research study, "Phase I trial of MR-guided Focused Ultrasound (MRgFUS) bilateral capsulotomy for the treatment of refractory Major Depression."  The fact that it was part of a research study made it both exciting, because I was doing something that could potentially help my depression which very few people had done before, and also scary, because they don't really know what the results of the operation are going to be.  Now that I have completed the operation, there are still more things that I have agreed to do as part of the study.  I will be having check-ups with the team at the 1 month, 3 month, 6 month and 12 month points.  Additionally, as my neurosurgeon said, they will be tracking me forever.  Since I was one of the first people to get this surgery they will want to see how I do for the rest of my life.

Since my experience with this research study was a positive one, I was open to being involved in a second research study when my neurosurgeon asked me.  This second research study is not a clinical trial for a procedure or medication, but is instead an examination of what both doctors and patients think about novel brain devices/procedures, and how doctors and patients make decisions regarding whether to use new brain surgeries.  Basically, they want to find out how patients make decisions about whether to go ahead with brain surgery when that brain surgery is part of a clinical trial.  This second research study that I have been involved with is called "Key Stakeholder Perspectives on the Readiness of Novel Neurointerventions for Neurologic Disorders" and is being conducted by researchers at Sunnybrook Hospital, the University of British Columbia, Neuroethics Canada and the University of Toronto.

Taking part in this research study was pretty simple.  It consisted of a telephone conversation where the researcher asked me various questions about how I decided to undergo MRgFUS and why I chose it instead of doing Deep Brain Stimulation (DBS).  It was an interesting discussion and really made me think about my choice and why I decided to do what I did.

As readers of this blog may recall, originally I was leaning more towards DBS.  I was concerned that MRgFUS was so new, with fewer than a couple dozen surgeries having been performed in the world, that it was the riskier choice.  I felt that they didn't even know if this surgery would work yet and what the potential side-effects of it were.  DBS has been performed for many years and they have hundreds of surgeries performed with much data on how successful it is.

However, I was really persuaded by the fact that while MRgFUS itself is new, they have been creating lesions in this part of the brain to treat depression and OCD for 50 or 60 years.  They do know that this type of surgery can help about 50-60% of patients, which compares favourably to DBS.

Then there is the fact that with DBS they have to actually open up your brain to insert the electrodes into your brain.  It is very invasive and leaves you with a device implanted in your body.  There are many more risks associated with DBS that come with them cutting into your brain.  These risks include the possibility of seizures, the possibility of brain bleeds and the possibility of infection.  MRgFUS, on the other hand, is minimally invasive in that they make permanent changes to your brain without actually cutting into it.

I also really thought about what would happen if the procedure didn't work.  With MRgFUS, if the procedure didn't work, I would likely be the same person that I was before the procedure.  However, with DBS, if it didn't work I was stuck with this device implanted in my body that I would have to deal with.

There were down sides to MRgFUS though that I had to reconcile with.  It does make a permanent change to your brain which means that any side effects are permanent as well.  The potential side effects include possible problems with short term memory.  That's not a good thing to have happen, but is a low probability event.  MRgFUS also doesn't allow for adjustment after the procedure is performed.  They do it once and you get whatever you get from that attempt.  With DBS however, they are able to adjust the settings of the device over time to improve the likelihood of being able to improve the depression.

So, when I had to make my decision, I think the facts that MRgFUS wasn't quite as new as it seemed and that it was minimally invasive swung my decision in its favour.  It's still too early to tell if I made the right decision.  In fact, we will never be able to know if things would have turned out better if I chose DBS instead, but I think that I made the best decision that I could have under the circumstances.

It has now been 10 days since I had the surgery and I can't say that I have noticed any difference.  I still feel just as depressed as I was before the surgery.  Nothing has improved.  That is a little bit disappointing, but it is still early.  They said that I probably wouldn't feel anything for 3 months to a year after the surgery.  It would have been nice though to come out of the operation and to feel something different right away.  Even if it was just some small change to let me know that the operation had an effect and that bigger changes were possibly on the way, would have been encouraging.  However, that hasn't happened so far.  I will keep you updated as we progress over the next year.