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- เผยแพร่เมื่อ 21 ต.ค. 2024
- Placement of Peripheral Nerve Stimulator beneath the skin at the base of the skull. Electric currents from the stimulators wire leads blocks pain impulses traveling up the Occipital nerves. These pain impulses cause severe chronic headaches. The electric current is delivered to the wire leads via a battery pack placed in a skin pouch most commonly fashioned over the patient's chest wall, abdominal cavity or flank.
I had this procedure as part of the FDA clinical trial back in 2009. It was a double blind study of like 1600 chronic migraineurs. We all had this surgery and were given PNS (which the trial called Occipital Nerve Simulator or ONS). Every unit was programmed and we were all partial awaken after the placement of the electrodes and leads to insure that we could feel the stimulation. The surgery itself even for the study took maybe 1 hour or less than 2 hours.
I unfortunately was in the control group, our units were not activated but we were given all the equipment to operate the PNS and told to use it. We had appointments every 2 to 4 weeks for the first 3 months. Then at the end of the control we were asked if we thought our PNS was activated. I thought mine was on but that it offered no relief or did nothing. I thought I was doomed, that I had failed the device and would never be able to even try to work or live a remotely okay life. Then the doctor and representative of the implant maker looked up my implant number and told me mine was not activated and I was asked if I would like to have unit turned on. Again I asked what will it do, what is it suppose to do, how does it feel? They said because we were still in the active study they couldn't tell me but I could have it activated and they could turn it on and we can see what I or if I feel it and them adjust the programmed settings for stimulation. I said okay and they turn it on.
I exclaimed, "What the F--K is that?" and at the same time I could feel my brain shifting focus from its eternal pain feedback loop to trying to figure out what THAT was. When I was at the appointment I had a level 8+ migraine. Then they changed the settings on the program and set parameters for what was too strong and what was too weak then which pulse patterns made me feel better, which did nothing and which made me feel worse. The appointment was scheduled to be a no less than 3 hour appointment while they fine tuned each of the 4 different patterns I was assigned. During that time they asked me to tell them when they found a pulse and strength that seemed to be changing my migraine attack.
They found it. And while they worked on the programming they let me just sit and see if the stimulation changed anything. After 30 minutes I said "My brain is confused, it keeps trying to keep the migraine attack going but then it, I don't know stops and shifts focus to that feeling of the stimulation. It's weird. My migraine attack is backing down." They were pleased. I left the office first time not reeling in horrific pain. Able to think clearly. They told me to experiment with the patterns and strength and turning it off, leaving it on and only turning it on when the chronic migraine increase in pain.
I found that for me one setting knocked my migraine pain from a 9/10 down to a 4/5 which I could tolerate. And weirder that at 4/5 I actually had to think "Is there any pain?" I ended up finding for me that leaving it on 24/7 was best. My settings were so high that I used up the 1 year battery in just 3 months of using the ONS/PNS. They offered me 2 choices either have the entire thing removed or let them replace the 1 year battery with a stronger rechargeable battery. I opted for immediately replacing the battery with the rechargeable battery. The thing about having the battery replaced was that I had to sign consent that if during the process of removing the battery the leads were cut or damaged that they would need to replace the entire thing which meant shaving the back of my hair off again, reopening my head and running new leads down my neck to the battery. This time when the replaced the battery they didn't need to wake me and they leads weren't damaged. I had noted the time the surgeon put me under and when I was woken up in recovery it took them about 15 minutes to replace the battery. They had turned the unit back on when I was in recovery and I awoke fully from anesthesia minus my usual migraine attack pain.
The thing was a life changer. I didn't know what it was suppose to do but I know for me it distracted my brain and prevent my brain from going into a feedback loop of escalated pain. And that if for some reason the attack actually managed to escalate I could keep increasing the strength until my brain had to abandon maintaining the high level attack and was confused and focused on the stimulation. It was and remains incredible.
Every appointment I report how much abortive medication I had to use and how long I used the ONS/PNS. At the end of the study they showed me my personal reports of pain before the ONS/PNS versus with it. MY pain decreased dramatically and kept decrease by small increments over time. They asked at the end of the second phase if I wanted to keep going. I said Yes please! And 4 more patterns and settings and individual control over the leads on the left and on the right was added. I had to tell them which patterns worked which didn't and oddly one made my physically ill. They thought that was fascinating and they removed that program from the PNS.
At the end of the 13 months for me since I had about 20 days with any power to my PNS while they ordered, scheduled and replaced the dead battery, I was asked if I wanted to keep going and be part of the long term study and keep the implant. Hell yes! Then the NIH and Dept of Labor asked me to participate in two studies they were running at the same time about the effect of chronic migraine on my life before the implant and after. that went on for two years. Again at the end of the extended ONS/ONS trial I was asked do I want to keep the implant or have it removed. I kept the thing. I remained on permanent SSDI until it seemed like my head pain could be at least 50% or more managed by the ONS/PNS. So from 2009 until 2013 I was on SSDI. I got regular calls from all the studies asking for reports. And was actually able to resume fairly strenuous physical exercise and exertion with no increase in pain.
The only caveats about the prototype ONS/PNS implant I received was that I could not go through metal detectors or ever have an MRI again. At that point I was like "Geez I never get hurt bad enough to need an MRI, and my neurologist said she could settle for CT Scans of my brain so that was fine. You get a NIH card that says that you cannot go through metal detectors and must be handwanded or patted down and that you cannot have any MRIs at all or diathermy. It lists the doctors info and basically is Federal Authorization to skip metal detectors everywhere.
That was excellent until I went back to work full time at a very physical civil servant job. As I've aged my migraine disease changes and second year working it changed. My brain if I was physically exhausted or had overexerted myself was able to overwhelm even the highest settings on the Implant. A call to the Implant Maker and an immediate appointment was set with the RN/Programmer to see if just the programming again would help. It did.
The bad part is now that I got injured at work and had some other health issues develop and every doctor and surgeon has asked or wanted an MRI before processing with surgery or treatment and I have to explain several times that I can never ever have or even be near an un-shielded MRI machine. The RN told me what they thought might happen if I went through a metal detector aside from the fact that it would set off the detector. They thought metal detectors might change or boost the amps on the unit or cause other unpredictable issues for the implantee. MRI machines would simply rip the leads, electrodes and battery from your body caused bodily harm or again it would boost the amps on the impulses to such high levels that it burned out the electrodes and damaged the occipital nerve area. Oh.
Well now there are different MRI safe version of PNS and other neuromodulators which is good cause I got badly hurt. Xrays showed no breaks so I was told I was fine. I wasn't. I had a broken foot and ankle and soft tissue and ligament tears that didn't show on Xrays and didn't provide enough detail with a CT. Then my knees which slammed into the concrete at full force experienced delayed reaction swelling which lead doctors to realize that I had meniscus tears in both knees. I was told I this would heal. It hasn't now I am on to specialists for each injury and they all need MRIs to see the details and exact locations of these serious injuries in order to fix them. Meanwhile, my Civil Servant jobs Worker's Comp Insurance company decided that I was fine since the Xrays showed no breaks and basically bribe the WC doctor to send me back to work with no further treatment and no restrictions on what I physically can do. Mind you I have been able to squat, kneel, bend my knees to a normal point, my left knee cannot bear weight and it sometimes hyper-extends backward far enough that it is dangerous. So I wear heavy braces on my knee and use a cane still to get around, only my employer won't allow me to use my came outside the office.
A year and a few days after my fall last year I accidentally tripped and fall while working. I immediately went to the WC clinic and they again said things are just bruised and that I will be fine in a few weeks. Only the Orthopedic and WC Podiatrist I was eventually referred to said no I won't be fine. I may have just torn ligaments in my foot and ankle and cause a stress fracture or two to my previous injured still ailing foot and ankle and they have no idea how seriously my hands are injured but they say bruised or sprained the specialists say nope its something else. I need MRIs and surgery. I saw a neurosurgeon today to get the implant removed and replaced w/ an MRI safe device. There will be a lag between removal of the prototype and re-implantation of a new device. But I have to risk it. I will want PNS back because nothing cures Migraine but this helped me.
TL:DR - I have one of these!
Long long story short I am glad I got this surgery done. For me the implant worked amazingly well. I have to have the prototype implant I got and kept removed because its not MRI safe. Once it is out I hope that my brain stays trained or tricked into not boosting the migraine pain. Once every needed MRI is done the neurosurgeon will re-implant another PNS but he will implant one of the new MRI safe units so that I can have any needed MRIs without having to go through brain surgery over and over. But we may find that after 7 years of constant stimulation that I no longer need the device.
A little shorter- It worked for me. It stops my brain from focusing on increasing the pain and lowers my migraine pain. My PNS isn't MRI safe and I have have several MRIs to correct some injuries. So my old PNS/ONS will be completely removed. The neurosurgeon will wait to see if I need have the device re-implanted because it might have retrained my brain to not make pain or made it more difficult for my migraine to make more pain.
Feel free to ask me any question you have about how it feels for me to have this PNS in my head. But ask quickly because its going to be removed soon so I can be made whole again. Also how it feels and works for me may not be how it feels ad works for you. I met another study participant and she uses her intermittently to stop migraines at the start or the stop migraines that started at a high level. How she describes the feeling of the stimulation is different than how it feels in my head.
Thanks for sharing!
my girlfriend has this for epilepsy and she hasn't has a seizure like grand maul shaking on the ground for 2 years!! it has been a blessing! not for everyone tho!
+Kyle Churman That's not quite the same as they actually place the wired in the brain for epilepsy treatment whereas the wires are only placed subdermally for headache treatment. But that's awesome to hear that it works for her. I've heard of similar positive results for Parkinson's patient.
I know there's a trial being done at OSU in Columbus. I started having hedaches in June of 2011, and with me having hydrocephalus and all the scans coming back showing no problems, I was just waiting to turn into the girl from THE EXORCIST. In March of last year, I was referred for the OSU study. This past October, I had two surgeries: one to place a temporary external unit as an experiment, and it worked so well, then a week later, I had another surgery to place the permanent internal unit. Three months after those surgeries, I had to have another surgery when the lead from my unit came loose and migrated down into my neck. The only difference between mine and this is that the battery is in my lower back instead of my chest.
Rachel Wallace Doak it was good to read this. I myself have Hydrocephalus and am attempting to have this procedure.
This is being experimented in the UK now for Chronic Migraine pain, of which I have been a sufferer for 12-13 years now. If I go ahead with it, I hope it works. Hope the battery pack is smaller though...
Hopefully you now can do it wirelessly, via iPhone perhaps
is the battery stay inside of the body?
yes
This procedure should’ve stayed in the 1970s. We have nerve decompression now.
My pain clinic's did not recommend this either. The results, they have found not to be worth doing this.
+Sean Garbart Lots of doctors don't know much about this so they don't recommend it. If you're still in pain, I'd suggest you look into it. Things have come a long way in the 2 years since you posted this comment. There's a really informative FB group if you're interested.
I had this in 2015 after 8 years of 24/7 migraine headache. I now get maybe 2-3 headaches per year.
I know not everyone will respond as well as I did to this, but it changed my life for the better.
It didn't work for me.
+Brian Coady Sorry to hear that. Mine has been amazing. 80% pain reduction.
Good grief. Everything for treating this condition looks Frankensteinian to me !