Dr. Michael Kaplitt, Professor of Neurological Surgery and Vice Chair for Research in the Department of Neurological Surgery at Weill Cornell Medical College, talks about a new method of outpatient brain surgery using ultrasound beams to noninvasively change the way the brain functions to improve disease.
Interview conducted by Ivanhoe Broadcast News in December 2017.
Let’s talk about the ultrasound and how you use the ultrasound to do something amazing.
Dr. Kaplitt: The idea behind focused ultrasound is that we can use beams of ultrasound to actually change the way the brain functions without doing any invasive surgery. Most people don’t realize that ultrasound actually will go through the human skull and there’s a way in the MRI machine that we can focus those beams. Imagine when you were a kid and you used to use a magnifying glass to focus light on a leaf, and all those light beams would concentrate on one spot and actually burn a hole in the leaf. We can do something very similar with ultrasound where we can focus all these beams of ultrasound. Each beam as it goes through the brain is very safe but when they converge or when they add up at one spot then they can add up all of their energy to the point where we can actually heat that area of the brain. If there are areas that are functioning abnormally, we can use this to burn and destroy these areas allowing the rest of the brain to free up and function more normally. The first disease that we have been treating with this, that was FDA approved last year, is for a disease called essential tremor, which is just a tremor when you start to move. It’s when people look fairly normal when you’re just watching them but then when they go to eat or drink or write they can’t control their hand and it starts tremoring like crazy. It’s a very different disease than Parkinson’s disease which people are a lot more familiar with. Many people have not heard of essential tremor but it actually is about five times more common than Parkinson’s disease. It can be very disabling to people who are trying to perform these normal activities during the day where their hand can’t really be controlled well and that’s because there’s an area in the middle of the circuit that controls movement that is not functioning properly. By sending these beams of ultrasound to that spot we can eliminate that abnormally functioning spot, freeing up the rest of the movement areas of the brain to function more normally. We can stop the tremor on the procedure table right away without any open surgery without any knives, with any hole, without leaving anything inside their body. So this is truly noninvasive brain surgery.
What are the concerns of doctors who are not using this procedure and why aren’t they?
Dr. Kaplitt: I think there are a few questions that some people have. One, is of course the effect of this is permanent; we are permanently changing the brain. The alternative procedure that we’ve been doing for twenty years is called the brain stimulation where you put a wire, an electrode, in the brain and that sends electrical pulses that can control the tremor. It’s attached to a battery that goes in the chest that controls it like a pacemaker. That is adjustable and reversible whereas this procedure is permanent. On the other hand that is leaving a device inside someone’s body and you’re invading the brain. You have to physically make a hole and pass that through the brain. So the concern here of course is that if we are not precisely targeted and if this ultrasound affects an area that we do not want to affect, there could be a permanent side effect that you don’t want to have happen. Things like having trouble speaking, having trouble moving your arm or hand, or having some numbness. These are areas that are all nearby the area that we’re targeting and so if we’re off by a bit you could have a permanent side effect. The way we prevent those side effects is by doing this gradually, it’s not all or none. We don’t send the ultrasound at a high energy to make it permanent right away. We actually do it gradually where we slowly raise the temperature so it takes time on the table. At a lower temperature we can essentially stun the area without making it permanent. So we can see improvement in the tremor temporarily without side effects, then we know we’re in the right spot. If we see some side effects with poor tremor control then we know we need to move a little bit and we can actually electronically move these beams to the spot we want to go in. We’re interacting with the patient in real time during the procedure to make sure we’re in the right spot, to make sure that we’re not hitting anything that we don’t want to hit, and we’re also looking on the MR screen to see exactly what we’re heating. By both looking at what we’re heating anatomically, looking at the pictures to know where we are, and by seeing the patients responses for good or bad we can tell whether or not we’re in the right spot to reduce the risk. So that is one concern, the permanence of any poor affect. The second concern is how long this will last. The procedure has only been available for a few years and brain stimulation has been around for twenty years. I personally have patients that are almost twenty years out with DBS that are still doing well. Obviously I cannot say that about ultrasound but I have patients that are now at least a year to a year and a half out from the procedure that are doing very well. We are increasingly confident that if you have a good benefit, it is likely to last a long time. But like any new technology we won’t know how long it will last until we’ve had enough years to be absolutely certain. The third issue, that hopefully is temporary, is that because it is a new procedure, right now most insurance companies and Medicare have not yet decided to cover this. This is true for many new procedures, even though it’s an incredibly cost effective outpatient procedure. When we do this procedure at our center, if the MRI looks good after we’re done we send the patient home an hour later. You would never do that with invasive brain surgery. I have treated patients over ninety five years old and I’ve sent them home an hour after the procedure. That’s a very different thing, because we are not opening the head and invading the brain we can have confidence that we can send people home which of course makes this not only better for the patient theoretically but also much more cost effective. We are hopeful that over time these things will be covered by most insurers and by Medicare. Then as a result of that I think you’re going to see much wider adoption of this procedure.
So who funded this study?
Dr. Kaplitt: This study that led to the FDA approval was funded by the manufacturer of the device, a company named Insightec. It’s an Israeli company that figured out many years ago how to combine this ultrasound technology with what we call MR thermometry. MR thermometry is an ability in the MRI machine to measure temperature anywhere inside of tissue including the brain. By marrying this ability to measure temperature at any spot in the brain with the ability to deliver these ultrasound beams to a focused spot and to adjust to another spot if need be they were able to figure out how to make this a useful device for this procedure. They were the ones who funded the study.
Are you directly or indirectly compensated by the manufacturer for you involvement with this procedure part of the drug.
Dr. Kaplitt: I have received no compensation from the company for any of the studies that I’ve been involved in with them other than being an investigator in the studies. Other than Insightec providing the cost of the study, which includes the cost of my time when I’m actually treating the patients, I’ve had no financial involvement with this company what so ever.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Michael Kaplitt, MD, PhD
Ana Sokol
646-962-9472
Sign up for a free weekly e-mail on Medical Breakthroughs called
First to Know byclicking here.
