Neuro Pace and guinea pig

[vtsammy]

I went to follow up w/ my Neurosurgeon a few days ago. The good thing is that the neurologist Pace is rather small (about the size of a thumb) and they are working on a battery that lasts longer about 5 years in the next year or so. With that being said, the surgeon told me that this is a clinical study that is not yet fda approved and has been going through testing for 3 years. He told me that they are allowed only 10 patients for each hospital because they want to make sure they can keep a close study on their patients. That made me feel better knowing that they will be there whenever I have any questions or concerns. Then I asked him how many patients for the RNS the hospital has and he said 2. 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

[hamatreya]

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.

[brain]

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.

***WHEW***

I thought I was loosing my mind (pardon the pun)
for a moment there ..

But NOW you can see from my posting DOWN THERE
were actually from that "idiots" as you remarked.

And NOW you can see why I had retreated and
why I had been so confused. I did post a remark
in a comment section in a special place.

I esteem Dr. Morrell very highly and have her
books, and I know some Neurologists and an
Epileptologist from way up North - and they
blabber about her a lot (motor-mouths)...

And that's how I got to know so much about
her. While VNS scared me - I'm still interested
in the RNS - but as you commented .... but
I am not even sure where I am supposed to
truly even turn to or head to.

My area isn't "famous" for much of anything
except for Sunshine, Beach, and Hurricanes!

[vtsammy]

Hamatreya,

What I am concerned about is that I was told from my Neurologists is that there are a total of about 130 patients throughout the US. As you said before there is a small slit in the scalp, the doctor told me that they have to cut a bigger area than simply just a scalp. The fact that there is such a small number of patience is what makes me nervous. I was also told that the neurologist Pace WAS approved by the FDA. After doing my research and find that the neurologist Pace WAS no approved for people, the only thing that WAS approved is the actual clinical trial. I thought this was quite misleading.

Sam

[brain]

Hamatreya,
I was also told that the neurologist Pace WAS approved by the FDA. After doing my research and find that the neurologist Pace WAS no approved for people, the only thing that WAS approved is the actual clinical trial. I thought this was quite misleading.

Sam

SAM:

You are confused.

NeuroPace is available. It is approved by FDA.

RNS is something that NeuroPace is progressing
on and is approved by FDA for research for
Clinical Trails and Studies. It is a PART of
NeuroPace.

2 Different things.

Hope that clears things up!

[Bernard]

brain, NeuroPace is the name of a company. RNS is the name of the medical device they manufacture.

[brain]

brain, NeuroPace is the name of a company. RNS is the name of the medical device they manufacture.

Feel free to pound my head Sam as
many times as you desire to the wall!
I apologize.

[Bernard]

The results have not been released yet, so how could anyone claim x% responded in any way?

I stand corrected. NeuroPace did publish the results of the initial study:

During the primary evaluation period, the responder rate (>50% reduction in seizures) in 50 subjects (excluding 1 subject with no disabling seizures at baseline and 14 subjects blinded off) was 32% for CPS (n=44), 63% for GTC (n=16), and 26% (n=50) for total disabling seizures (TDS) (SP motor, CPS and GTC). The median percentage reduction in seizure frequency was: CPS 27%, GTC 59% and TDS 29%; seizure reduction was significant for CPS (p<0.05) and TDS (p<0.001) (Wilcoxon signed-rank test). For the secondary evaluation period, as of 4/28/06, the responder rate for 62 subjects (excluding 1 subject with no disabling seizures at baseline and 2 subjects previously blinded off with fewer than 84-days of therapy on) was 40% for CPS (n=52), 55% for GTC (n=22), and 41% for TDS (n=61). The median percentage reduction was: CPS 34%, GTC 66% and TDS 35%, and seizure reduction was significant for CPS (p<0.05), GTC (p<0.005), and TDS (p<0.001). In 65 implanted subjects (including 17 device replacements) representing 65 patient years, there were no serious unanticipated device-related AEs, and responsive neurostimulation was well tolerated.

SAFETY AND PRELIMINARY EFFICACY OF THE RNS™ RESPONSIVE NEUROSTIMULATOR FOR THE TREATMENT OF INTRACTABLE EPILEPSY IN ADULTS

It looks like they averaged around 30-40% of patients achieving >50% reduction in seizures overall (based upon the TDS numbers) depending upon how long they had been using it with more patients (outside of the 30-40%) achieving a lesser degree of seizure reductions.

[Dr. Martha Morrell]

I appreciate the opportunity to provide information about the NeuroPace RNS™ System and about the ongoing clinical investigation. Some of the information may have already been discussed, but I think it is important to confirm a few things that eveyrone who comes across this thread may not be aware of.

It is hard to decide whether to participate in an investigational study. Gather all the information you need to be comfortable that you have made the right decision for yourself. Candidates for the trial are between 18 and 70 years of age, have partial onset seizures from one or two focuses in the brain and have not had seizures controlled despite trials of two or more antiepileptic medications. There are other eligibility criteria as well. Good places to get information about the RNS™ System trial are from the web site www.seizurestudy.com, from physicians participating in the trial and from your own treating physician. I am also available to answer questions from people who are considering participation in the trial.

The RNS System includes a neurostimulator and leads, as well as a laptop based programmer for the physician and a laptop based data transmitter so that the patient can send information from the RNS neurostimulator over phone lines to the physician. The neurostimulator sits within the skull and the leads are placed within the brain at the seizure focus. The neurostimulator contains the battery as well as the computer chips that allow the device to monitor and record brain electrical activity, and to deliver stimulation pulses in response to abnormal electrical activity. The physician ‘tells’ the device what to detect and when to deliver stimulation. In this way, the physician determines how much stimulation is delivered.

People who are receiving more stimulation will have a shorter battery life and those who receive less will have a longer battery life. Depending on how the physician programs the device, at present the battery life is about one and a half to two years. When the battery is low, the neurostimulator is changed. This involves an incision in the scalp. The old RNS neurostimulator is lifted from its location in the skull and replaced with the new RNS neurostimulator. This procedure does not require brain surgery. While there are risks with any surgery, replacing the battery is an outpatient procedure and patients are generally able to resume their normal daily routine the following day.

Another issue I feel is important to address is that of efficacy. As Bernard and Hamatraya point out above, the results of the current pivotal study are unknown – even to us at NeuroPace. In order to gather the most accurate information on the device’s efficacy, no one has access to the efficacy data until the end of the trial. Therefore, no one can tell you how many people are seizure free, worse or not changed. It is important to note that the RNS System has been evaluated for safety (as opposed to efficacy in controlling seizures) in an earlier feasibility trial that included 65 adults with medical uncontrolled partial onset seizures. Based on these results, the FDA approved moving forward with the next step – the current pivotal investigation. The device itself is not FDA approved.

Another question came up about the magnet and the ability to turn the device off. The RNS System comes with a hand held magnet. The magnet can be placed on the scalp over the device and the device will turn off as long as the magnet remains.

I hope this helps. Again, if you have specific questions, please post and I will try my best to reply.

Sincerely,

Dr. Martha Morrell

[Bernard]

Hi Martha, welcome to the forum.

That's a great summary and answers all the issues raised in this thread. Thanks for taking the time to respond to the discussion.

It's very generous of you to offer direct access for questions regarding the device/clinical trial. I would like to ask CWE members to please use the PM system for any personal inquiries and post in this thread for questions that may be of general interest.

[vtsammy]

Dr. Morrell,

As Bernard said that was a great summary. I appreciate your help, especially since I have in the process of deciding if I want to go w/ the neurologist Pace as my option.

Sam

[vtsammy]

Dr. Morrell,

By "leads" is that same thing as electrodes? I was wondering if the leads are connecting to the focal point of the brain, doesn't that require brain surgery so that the leads actually touch the brain? And when you replace the RNS neruostimulator after a few years, do the leads have to be replaced as well?

Sam

[hamatreya]

Dr. Morrell,

By "leads" is that same thing as electrodes? I was wondering if the leads are connecting to the focal point of the brain, doesn't that require brain surgery so that the leads actually touch the brain? And when you replace the RNS neruostimulator after a few years, do the leads have to be replaced as well?

Sam

The electrodes are located at the ends of the leads, and the electrodes that deliver stimulation are touching the surface of the brain.

The implant procedure is neurosurgery, your brain has to be exposed (briefly) to allow the placement of the electrodes exactly on the predetermined seizure focus. But replacing the RNS in your skull is not neurosurgery. It's not cranial invasive.

Don't be hung up on the idea of the implant procedure being a daunting surgery to undergo. If you've ever had neurosugery before, it's nothing like having your skull drilled through for the first time.

If you are worried about some type of infection from the contact between man made matter and brain matter, the FDA has already given its consent to using this device (i.e., it's proven safe to use, whether it will be truly effective in eliminating , or at least reducing,seizure activity remains to be proven).

One of my neurosurgeons called it "barely brain surgery" because so little contact is made with the brain during surgery. The consent form is about 20 pages long, and I must have had several pages of questions beforehand. I think these are all good questions you are raising, by the way. If you weren't concerned about being in a clinical trial, that would be worrisome.

I haven't heard of anyone needing the leads replaced inside the skull, and I can't imagine why they would need to. Once they're in you, they're in for the duration, which hopefully will be your entire life.

Dr. Morrell can probably answer all this as well, maybe she's already PMd you. I don't think she spends a lot of time on this website, but maybe if you (or already have) sent (send) a PM, she'll respond. Also, call or email your neurosurgeon's office. I'm sure they would get back to you.

[vtsammy]

Thanks Hamatreya. That was very informative.

[RobinN]

Sharon -

Sometimes I just wished that car accident didn't make me deaf overnight!

I have a relative that had a hearing aid implanted somehow... and he has partial hearing now. Have you heard of this device? His hearing disappeared overnight for no reason, or none that I know of.

[s10sleeper]

According to the info that I have gotten from my epileptologist they are still in the investigative phase and not FDA approved for this reason. I recently had to go through all the testing to prepare for surgery and found out that I was not a good candidate as doing it could cause me to lose my speech ability so they are suggesting me for the RNS. i know that it is a longshot but at this point I am willing to do anything as these seizures haave come back to haunt me worse than ever and are causing me problems at my job and in my personal life, and medication does nothing, I still have seizures daily. For this reason they are suggesting the neuropace and i am willing to try anything.

[Bernard]

This video provides a good overview of the RNS and differences between the RNS and VNS:

Part 1:


Part 2:

[Mr. Pibb]

I relieze that this is getting away fron the topic but RNS would like for you to be having at least three seizure in a given mo to qualify with the way that my meds are doing there job this gets to be unlikely take away or mess with the meds and walaa!! seizure nonstop yet I dont qualify. This is one study that is of intrest to me not only because it might work but getting in on the ground level has a certain appeal to it.
Jerry

[Rhonda2999]

Found this site while looking up info on Neuropace. My brothers wife has just this week decided to take part in the study. We are all very nervous and excited for her. They have a sweet 4 y/o who doesn't understand why mommy doesn't feel good. I am praying for positive results from the study just so that she can have a better quality of life. Thanks for all the info here and I look forward to reading more.
Rhonda

[Bernard]

Welcome to the forum Rhonda.

Best wishes for your SIL!