Easy for me to say now, but what is the concern?
Ok, so now this is what got me concerned. Obviously he wants me as a patient because they need patients to try out this product. And the fact that he spoke w/ me for 1 1/2 hours answering each and every one of my questions. How many doctors do we know of that will do that for you? Just from my past experience, I've never been to any doctor (general or specialist) that has ever done that. I've decided that I'm going to wait at least a few years before I give it more thought.
Sam
I'm not sure what you mean by "concerned." Is it waiting for a newer, longer life battery? Waiting for FDA approval? Being part of an investigational trial to begin with? Or, is it the idea that the study centers want so few participants, or are you implying there are too many in the study to begin with?
Whether you wait a few years or not, should you eventually have a RNS implanted in your skull you will need constant monitoring for years. That isn't going to change, regardless of FDA approval. The device isn't less safe now, or safer later. What the FDA is being asked to approve is the current device (literally, the "Neuropace 300"). That is what you would receive two or three years from now.
It is true that a "next generation" neurostimulator is already on the drawing board, but, should it be developed four or five years from now, it will also need to go through the FDA clinical trial approval process. And if you are able to obtain satisfactory seizure control with the current model, there would be no need to upgrade.
It will take at best months, and probably a year or two, to reach the optimum stimulation settings for any patient. This is the reason the neurologists and Neuropace engineers need to meet you so frequently.
Being at a study center that hasn't yet reached its qouta of study subjects doesn't mean they will be any less skilled than the doctors who have ten patients with the Neuropace.
An advantage of having the implant neurosugery is what doesn't occur. No resection of brain tissue. If you remove part of the brain, there is no going back. With the RNS, even it it proved useless for you, or failed to gain FDA approval and was simply turned off, your brain hasn't lost any function.
Everybody has to make their own decisions. I was told of patients who, after going through brain mapping and grid placement surgery, opted for either a multiple subpial transection surgery of an eloquent cortex,( meaning partial seizure control) or no surgery at all, ( meaning continued intractable epilepsy) rather than agreeing to proceed with the RNS study.
I hear this so often from the doctors, that patients have an extreme reluctance to commit to a clinical trial that involves neurosurgery, and turn down the chance to be in the study. There can be a sense of wanting to get the process over with, to just have surgery, be discharged, go home and hopefully be done with epilepsy, rather than venture into the unknown.
Deciding to enroll in the Neuropace study can't be done lightly, because it will, if it works, be in your skull, with electrodes on your brain, for the rest of your life. The fact that a neurosurgeon would take so long to talk to you reflects this.
Incidentally, I called the phone number on the Neuropace banner ad at the top of this page, and those people are idiots. It' s not clear to me if the people (supposedly "nurses") who answer the calls even work for the company. Seriously. A potential participant would do better emailing an epilepsy center listed as taking part in the study.
