Dear Migraine Sugars,
I'm sorry I haven't updated this page at all in months. I was living my life and dealing with financial and family issues.
I think I may have said in my last post that I went to my follow up appointment for the ONS clinical study in May 2009. At that time, I found out that my ONS device was never turned on and that I was part of the "sugar pill" placebo portion of the study. They needed to see if the knowledge that I merely had the device implanted was enough to trigger my brain to overwhelm the impulse to have an attack.
Uh no it wasn't. Intially, because of the anesthesia and the fact that there was an electrode resting on my occipital nerve in my brain I had minimal migraine attacks but then by March and April I was back to having nearly constant attacks of varying severity.
When I went to the clinical study office I was mortified when I found out that the device was not on because I was sure that I felt some shocks going through my head. Nope, it was my imagination but the clinical study people assured me that my reaction to getting the implant was the norm. The placebo people were so hopeful that our minds did attempt to mentally stop the migraines in order to be free of the symptoms of this disease but eventually the pain from the attacks would kick back up.
I also think that I mentioned that when they did turn the device on I received a horribly strong jolt a shock that went through my entire body and was extremely unpleasant. This happened whenever they would change from one setting to another. The study people couldn't figure it out and chalked it up to my body being slightly overly sensitive.
So from the moment they turned the ONS device on until late July or August my migraine attacks were lessening and becoming more infrequent. They ( the study folks) asked that I leave it turned on all the time, so long as I can stand it. When the device is on depending on the setting that I have it on I can feel a strong tingling under my scalp to feeling a strong rhythmic throbbing sensation to feeling a very strong constant stabbing sensation. I started on the mildest setting the tingling and found that my brain and my overactive nervous system rapidly adjusted to the impulses so I would have to up the Amps or change the setting. Eventually by the end of July 2009 my brain had adapted to the initial low settings on ONS device and I had to have the settings and Amps increased.
Let me tell you I went to the clinical study office a bit pissed that my brain was overwhelming the device and that I was failing the study and failing the potential other migrainuers who could benefit from his device. Once at the office the representative of the company that made the device met with me and I gave her an update on how things were going with the implant. At that point I realized that even though I had had migraine attacks after the device was turned on that they had not been as bad as they were before and weren't as frequent. I fact I was feeling pretty good and very energetic. I hadn't felt that energetic since before I turned 28 and the migraine attacks became increasingly more frequent.
So the representative from the ONS device company set about changing the settings for me and increasing the amplitude of the impulses to my brain. And surprise when she went to change the setting, which I had not done in over a month, I got a huge shock. I mean I jumped high off the chair and she could see my whole body tense up. She couldn't figure out why this kept happening as she changed the settings. Every time I got a jolt. It got to the point where I would brace myself before she changed the setting. Eventually we came to the consensus that I am just a circus freak - far to sensitive the electric impulse that when there is a change in the impulse my nervous system lets my entire body know. It isn't much different from what happened with my brother-in-law and his MS. If you pinched his leg he didn't immediately feel it but later on his leg would jump and kick then his entire body would spasm and he'd yelp in pain. I remember read about his form of MS and that his spinal cord wasn't transmitting messages in a proper manner if at all and when it did that it could and would misread the message and overreact. Well that was my response to the change in electric impulses directly into my occipital nerve - my body would overreact. I'm not even gonna mention what happened when I went into the SF Main Library through the metal detectors - I'll just say never again will I try to go through them or do I want to - I'd rather be strip searched or hand patted down.
OK so the representative from the ONS company changed the settings to stronger less rhythmic settings then she really upped the amps that the impulses could deliver and wow what a difference. I left the office with a bag full of relpax just in case the new setting weren't enough but surprise they were terrific. I actually would go days and weeks without having a migraine attack. I had one level 5-6 migraine attack and rather than taking the migraine abortive (relpax and diazepam) I took two Tylenol and the attack was ended. Then I realized that for the first time in almost two years I had just had a normal run of the mill mild headache. It was incredible. The device was working. I found the perfect setting to keep the attacks at bay and left it there. Instead of using the controller pad they gave me to change the settings or up the amps or turn the device off and on I used the strong magnet that they give me and I didn't get shocked by the device at all.
So things went swimmingly from the end of July to late September. Rare headaches, even rarer migraine attacks and I felt fabulous, free of pain and full of energy. I mean I was starting tasks and finishing them and exercising lilke a madwomen because I felt so great. I was actually even going out in social situations in because my inhibition problem was under control as was my extreme pain. I could focus and concentrate again.
I am not sure if I mentioned that I did have to give up my job as a bus driver for the city of SF. I even with the device I couldn't guarantee that my disease wouldn't take a turn in a different direction and endanger the safety of the citizens of SF as well as my own safety. So I was amicably separated from the city without prejudice due to a medical condition, meaning that should I desire to try to become a bus driver again the city will not hold my previous situation against me or my disease. And way back in April I decided after applying for many and failing to get a new job I decided to try to apply for Social Security Disability. I applied without the real hope that they'd recognize Chronic Intractable Migraine Disease as a real neurological disease, since most layman and general practitioners aren't even aware that migraine disease is a progressive neurological disease. Anyway, after filling out the initial paperwork, the subsequent medical release papers and medical questionnaires I was approved for full Social Security Disability. I was expecting them the want to examine me or to just flat out say "NO. It's just a headache" but there was no inquisition. The medical review personnel a SSA was shocked that I had been able to work as long as I had given what my neurologist and gp had said as well as what the numerous ER reports had said about my all to frequent trips to the ER for treatment for attacks that had lasted a week straight or longer. They rule that I am full disabled, possibly permenantly.
Being approved for SSDI was bitter sweet. Yes, the monthly payment would insure that I could have a roof over my head but not much else. And it meant that others were recognizing that I have a disease that is so bad and so unpredictable that it made working without any severe restrictions and exceptions being made by my employer impossible. Regardless of being approved and receiving SSDI I told myself that I would only stay on it for 6 months before I resumed looking for and pursuing a new job. So I'm back to looking for job that I can do, where I can be allowed to be a handicapped person with an odd often unrecognized disease and still thrive.
Anyway, let's finally cut to the chase. As I said everything was peaches and cream until the end of September when I started to again wake up with fairly severe migraine attacks. I would realize that my ONS device was off for some reason and I'd turn it back on and get relief but I had to resume taking the relpax in the mean time. Then I went to my first live NASCAR race in Southern California. I drove to my sister's house then from my sister's house in Ventura to the race track in Fontana which was 111 miles away. Everything was great at the track. The extreme noise and vibrations from the powerful cars didn't bother me in the least. The fumes for the cars caused no headache or migraine attack while I sat on the first day watching the Sprint Cup drivers practice. Nothing not a peep from my head but I was having gut problems but that is another story for some other time. Then on the first day of practice as I was driving home in the horrible Friday evening L.A. rush hour traffic I was struck with a thunderbolt migraine attack. I had to pull off the freeway and take my emergency Relpax from my bag and sit and wait out the pain.
I made it back to my sister's house and grabbed my controller console for my ONS device and upped the Amps. Better but the next morning, race day for the Nationwide drivers, I was woken up at 4 am with an intense attack. Again, as a precaution I carry all my medications with me so I took the relpax and diazepam and waited. The attack receded and I dragged my nephews and their friends out of bed at 6am so we could head to the track for practice and the race. At the track I was terrific. No migraine attack, no headache, no nausea, no vertigo just my normal stomach ache. We stood for hours out on Pit Road where the stock cars were revving up and rumbling just feet away from us with no reaction except excitement.
Then after the race shock of shocks. The group that I had bought with me (willing) was munching down on our tailgating fare in the parking lot and suddenly my youngest nephew who had previous been migraine disease free at 19 started to say that he felt weird. He was covering his eyes. He was nauseated and dizzy. He was very agitated. He was confused. I watched him for about 10 minutes and though maybe he had heat stroke from standing on the hot asphalt of Pit Road then sitting in the sun-drenched bleachers for hours. Then my older nephew who has migraine disease too, said "I think Jeff is having a migraine attack. Look at his face. It looks like your face or my face when we get an attack." Sure enough he was right. But I hesitated to give Jeff my relpax because he's never been prescribed it and he's never had a migraine attack but he has had heat stroke before. I didn't want him having some drug in his body that could possibly worsen his condition if he had heat stroke. Luckily Tylenol is a major sponsor of NASCAR and while in were inside the track I had my nephew visit the booth for Tylenol and get handfuls of free samples. So we gave Jeff Tylenol and had him slowly but steady drink plenty of cool water and strip down to to his t-shirt and underwear and sit inside my car with the air conditioning on low. After 30 minutes he started to feel better and he ate and we drove home.
By the time we got home Jeff was not feeling good at all. He was very dizzy, confused, nauseated and that his head was throbbing worse like it never had before. He said his spine was even throbbing. He was sensitive to light and sound, he was intermittently angry and then elated. By that time I had taken his temperature and for him it was one degree higher but normal and I was sure it was a migraine attack. Of course my sister is a RN and she refuses to believe that not everyone has migraine attacks like she does (she actually has tension headaches - we know this because the migraine preventatives don't work on her but the tension headache medications do-still she wants to be part of my horrible crew of migraineurs do she insists that she "KNOWS" what migraines are like cause she's had them and treated patients in the hospital who've had them). Anyway, my sister insisted that because Jeff has never had a migraine attack in his head that this couldn't be a migraine attack and must be heat stroke. So she proceeded to try to treat him at home as if he had heat stroke - putting a cold wet blanket on him and making him drink ice water etc. This only made him feel worse until he was vomiting. So I asked Jeff quietly is he thought he could be having a migraine attack, being that over the years he had witnessed my attacks and his brothers attacks. Jeff answered "Yes. I think this is a migraine attack and it hurts so bad." I asked him if he wanted a relpax or if he wanted to go to the ER and let them examine him and treat him. He said he wanted the relpax, that he had wanted it in the car but couldn't remember the name of the medication. So then I asked him if he was having any other symptoms. He responded that the room was spinning violently, that he needed to vomit and even after he did he still felt nauseated and that his neck was so stiff he couldn't turn his head . Full on attack. Poor thing. I then told him that since he'd been dealing with the migraine attack for a while that it would be best if he took the pill the way that I do - crushed and mixed with a bit of water. So I crushed the relpax mixed it with water when my sister wasn't looking and Jeff drunk it down. I should have warned him that it tastes horrid. He kept it down. His older brother knelt next to him and told him that shortly he was gonna feel really weird and that it would be the relpax starting to work. Sure enough Jeff suddenly said he felt flushed then his arms were so heavy then he was tired, that he could hear his heart beating in his ears. I also gave him 1/2 a diazepam and he willingly used a compazine suppository for the nausea and vomiting. After an hour Jeff said the pain, dizziness and nausea were gone but that he felt so sleepy. Yup migraine attack. First one,very severe. His brother said that he felt horrible about Jeff getting an attack because he had hoped that this disease had skipped his brother.
Anyway, Jeff was relieved from his attack and within three hours I was having an attack myself. Boo! I took my medications and went to bed. Fast forwarding now. I ended up stuck in Southern California longer than I wanted or planned to be because I kept having more and more and stronger and stronger migraines. I couldn't understand it.
About two weeks after the race I had to go Arizona with my older nephew to an ice skating competition that he was competing. It was either sectionals or regionals (cannot remember) and my nephew was going to try to earn a position for the next up competition to go to Nationals. However, my nephew had like two days before the start of the competition caught the Flu. But he still wanted to go compete and he believed that if he just rested in between practices he'd be fine. He was partly right. We were in Arizona for 5 or 6 days and he was sick until the day we left but still he practiced his ass off at each scheduled competition practice then after practice we'd go back to the hotel and I'd take care of him trying to help him get through the flu and recover from his difficult practices. However, I started to notice while we were in Arizona that my patience with people was growing shorter and shorter and that I was having more sensitivity to the weather and to light and noise and the migraines were back with a vegeance. But I didn't focus on it because I was focused on my nephew.
Anyway, at the competitions he went out and skated with a fever and very runny nose as well as being dizzy but he gave it his all. He didn't qualify for the next competition but at he got some high scores and let the skating world that he was back competing (coaches and other skaters had thought that he retired because his firs coach quit).
As we were leaving I my nephew finally felt well enough to drive and I kicked back in the passenger seat for the 700+ miles drive back to his house. However again I ended up trapped at my sisters house because one my stomach problem had gotten really bad and unpredictable and two I was having uncontrollable migraine attacks again.
One night I woke up and it dawned on me that I couldn't feel the sensation of the implant in my head anymore. I couldn't think of when the last time I had felt the thumping sensation in my brain from the implant. I pulled out the magnet and ran it over the battery pack in my chest expecting the device to suddenly turn on but it didn't. I kept running the magnet back and forth over my chest - no reaction from the device. So I pulled out the controller console and tried that. For about 20 minutes the thing looked for a signal and waited for a response from the implant in my body and it got nothing.
What the hell? Here I am standing in my pjs at 3am in the dark placing this round paddle over the battery pack and nothing was happening. No huge shock, no little shock in fact the controller is saying that something is wrong it cannot find the unit. WTF? I stumbled into my sister's room and found some new batteries for the controller thinking that the controller was the problem. Nope. Suddenly I remembered that when we left the hotel the bellhop had failed to show up with a luggage cart so we had carried all of our heavy luggage down to the parking garage alone. I had overloaded my bag so it weighed like 25 pounds and I had to place it over my left shoulder and the strap had pressed hard against the battery pack and wires in my chest. I suddenly thought "oh my gosh I disconnected those wires that run from my head to the battery pack in my chest when we left the hotel." I panicked. Finally I remembered to take my medications but then I thought "okay the device is off and my migraine attacks are back and as bad as they were before the implant".
The next morning I called the clinical study people and told them what I thought had happened they scheduled me for an immediate appointment for an x-ray - to see if the leads were indeed disconnected or damaged. Then I called the representative from the ONS device company and told her what I thought had happened and asked if she knew anyway that I could fix it myself. She calmed me down and said there wasn't anything I could do short of self-surgery. She told me that when I got back the SF that she'd meet me at the hospital for the x-rays to see if the leads had been disconnected or shifted.
So I got back to SF driving 476 miles with a intense migraine attack and two crazy cats in tow. I got home the next day off to St Francis for a chest and head x-ray. True to her word the rep met me at the hospital and stayed with me through the x-rays. I didn't realize but she's actually a nurse practitioner or some such but that she's certified to read x-rays. So she and the x-ray tech immediately read the x-rays. She looked at the implants position on my occipital nerve. It hadn't moved and the wires (leads) were intact. She then followed the path of the wires down my neck looking for damage to the wires leading to the battery pack. No damage. Then she looked at the chest x-ray. The leads were still connected and intact. The battery in the experimental ONS device that I had gotten had died. Terrific news in a way.
So since late September when the attacks were increasing the battery in the ONS device was dying until it finally gave up. The rep assured me that the company would replace the ONS device for free and they would put in a rechargeable unit with a lifespan of 5 to 7 years on high amps rather than the experimental battery pack that was meant to last one year or so on moderate impulse. She said she was glad that I realized there was a problem and called her because now she knew to contact any other study members that were set on high amps and alert them and prep them for replacement of the battery pack. Also, that the company now would know definitively that that battery should be rechargeable when first implanted and that the higher the amps and shocks the sooner the faster the battery dies.
Okay that was late October, early November I had to suffer through crippling attacks again. Suffered through being bed-ridden from the extreme pain and going through expensive medication like it was water. I still am incapicated til the battery pack is replaced.
The thing I do know is once the device was set to the right levels, I was nearly migraine attack free. I was feeling great physically and emotionally. And that this ONS device actually worked! That was the most surprising thing. After the adjustments I hadn't really thought about the device at all, I was just out living my life again. I wasn't having to alter my behaviour or actions to avoid having an attack. I was my old self again, I was nice and in control of my impulses and feelings. As soon as the ONS device battery started to die the disease reared its head with a vengeance, making my life miserable and isolating me again.
So all I can say is I am glad I volunteered and was accepted for this clinical study. I'm glad that I had this experimental device implanted in my brain and chest and I cannot wait to get the battery pack replaced in 8 days. I'm ready to get back to living normally again.
My advice for other chronic migraineurs is that if the disease continues to worsen like mine did there are new treatments on the way! I believe that the ONS implant will be approved by the FDA early this year as this was the last study they needed to prove that the device worked for mild case as well as for extreme cases.
I advise all migraineurs to stay on top of the disease and the attacks. If you have medications to prevent the attacks take it as prescribed and if you have an abortive medication take it as soon as you feel a headache coming on. If the medications aren't working or are creating side-effects that are as bad as the migraine attacks then insist that your neurologist change the medication. If you don't have a neurologist who is up to date on the latest information regarding migraine disease then find one who is. Give serious consideration to the new long term treatments that are coming out now. And even if you have a neurologist that you trust in, you still need to do your own homework and research. Papers on new studies and courses of treatment are being published all the time.
If you don't already get the National Headache Foundation (NHF) newsletter then subscribe and read it. Neurologists and researchers are finding all sorts of new and interesting data about migraine disease and approaches to treatment. In the latest newsletter they have devoted considerable space to discussing what happens or what you should do (with your neurologist) if treatments fail to work for you. It's really useful information to have available. There are also testimonials from other migraineurs about how the disease is adversely effecting their lives and how they are dealing with the "invisible disease".
There is one other thing I wanted to say - after I got the implant but before it was turned on (when I was still a placebo patient) I had my normal quarterly appointment with my regular neurologist. I told her that I had gotten the implant (I had mentioned the study before I got approved for it as well). She was extremely skeptical and asked me if it was working for me. I told her that I didn't think it was working for me but that I was scheduled to go back the see the study people in a week to find out if the device was on or not and to have it adjusted if indeed it was on. She poo-pooed the entire thing saying that she thinks that I was proof that the ONS device didn't work for people with Chronic Intractable Migraine Disease and that for people with lesser forms of the disease it might work but it was too extreme and radical a prospect to be reasonable used. I left her office feeling like I had seriously fucked up since my neurologist is a top-rated specialist in the treatment of migraine disease. However, as I said my unit wasn't turned on and when it was I started to and continued to get relief from it (until the damn battery died). In August 2009, when the device was still working I had another quarterly follow-up with my neurologist and she was shocked. To her I looked totally different, I told her that the last time I saw her the device wasn't on and since then it had been turned on and adjusted to suit me and that I hadn't had the chronic constant migraine attacks and that my other symptoms were under control and that when I did get an attack that two Tylenol or if it was a little worse 1 vicodan worked to end the attack. She was speechless. We talked in her office for nearly an hour (my appointments are usually a fast 15 minutes). She wanted to see where the battery pack was and feel were the leads went into my neck up to my brain. She asked me tons of questions about what it felt like, how I thought it was resolving my migraines and whether I would recommend it to other Chronic Migraineurs. I told her that she should ask her office mate and fellow neruosurgeon because he did the surgery and is getting the results of the study now. I told her that I cannot and will not tell other chronic migrainuers to do what I did but that it was worth investigating whether the treatment was right for them. That there are criteria that I was not fully aware of in to be of the study or to get the implant - I just knew that I met the health and mental capacity criteria of the study to be accepted. She was very pleased that despite her negation that I had been proactive to pursue treatments that could help get the disease under control.
I have seen this same neurologist since the battery died and she now believes completely that this ONS device is a valid and rational method of treatment for my level of disease. She was pretty disappointed that the battery had died so soon but was glad to hear that it would be replaced with a rechargeable unit and that future implantees would automatically get rechargeable long term units.
I am sorry that this post is so long and I am sorry that there are questions that people have asked that I haven't answered but I was trying to get my life back. But that's no excuse, so if youhave questions that I haven't addressed or there is information you want from me just post your question or if you want email through this site.