More than 45-million Americans, or one in six, suffer from chronic headaches each year. We spend more than four-billion dollars a year on over-the-counter headache remedies. Even powerful prescription drugs don't always relieve the pain. Now, there's a new kind of headache therapy that may help severe headache sufferers when nothing else works.
For 17 years, Suzette Smith had to do without the girly things she used to love. She suffered with severe headaches, a pain that made feeling pretty, pretty much impossible.
"When the headaches start, it works down into your shoulders, into your neck to where you have a hard time sitting up and doing simple things like this. The headaches were so sensitive in my head, I couldn't hardly brush my hair anymore," said Suzette.
LSU neurosurgeon doctor Erich Richter offered her something new—an investigational implant. It delivers electrical impulses, targeting the nerve problems that trigger headaches.
"The way that interacts and the pathways that carry the pain and cause the pain to be processed by the brain in about 80 percent of people can get that pain under control," said Dr. Richter.
Headache patients get a temporary electrode device first. If it works, the next step is surgery to implant permanent neural stimulators.
"We can actually place a small electrode over the base of the scalp and that runs to a pacemaker-type device, which either can be implanted over the clavicle or usually actually in the upper part of the back," Dr. Richter explained.
Because Suzette has head and neck pain, her implant also includes electrodes down her spine -- all controlled with a remote.
"And this is program number five, and it's going to work my shoulders and my neck," Suzette added.
The touch of a button triggers a strong, tingly feeling that blocks the pain.
Three months after surgery, Suzette's headaches are history.
In terms of technology, a neural stimulator is similar to a cardiac pacemaker. Because the device is permanently implanted inside the body, the patient can go back to all their normal activities after surgery. LSU is one of the only medical centers in the United States performing this investigational procedure.
RESEARCH SUMMARY
BACKGROUND: Migraines and other types of headache -- such as tension headache and sinus headache -- are painful and can affect a person's quality of life. Migraine symptoms include a pounding headache, nausea, vomiting, and light sensitivity. Headache remedies include various types of pain relievers. Migraine treatments may also include anti-nausea drugs and medications to prevent or stop headaches.
CDH: Chronic daily headache (CDH) refers to a broad range of headache disorders occurring more than 15 days a month (in many cases daily) for a period of at least three months. There may be as many as 5 percent of the population encountering severe headaches on a daily or near-daily basis. Patients with CDH often overuse pain relief medication, which can precipitate or sustain the frequency patterns seen with CDH. (SOURCE: National Headache Foundation)
ZAPPING YOUR HEADACHE: Now, there is some relief for patients who cannot seem to shake the pain away. A new, investigational implant delivers electrical impulses, targeting the nerve problems that trigger headaches. To relieve the pain, electrodes are connected to nerves that exit the brain. An implanted battery then sends signals through the neck to turn off the pain. A neural stimulator is similar to a cardiac pacemaker. Because the device is permanently implanted inside the body, the patient can go back to all their normal activities after surgery. "The companies that make the pacemakers make these neural stimulators," Erich Richter, M.D., a neurosurgeon from LSU Health Sciences Center, explained to Ivanhoe. "They're the same technology as the cardiac pacemakers. I usually find that it's easier for the patients to get their head around it to just talk about it as just 'neuro-pacemakers.' It's very well-developed technology at this point. Some of them are MRI-compatible even. All of them can go through any kind of security system. You can go swimming. It's completely inside. The skin is closed. One of the technological advantages over the last five to 10 years is that these kinds of pacemakers are made rechargeable."
INTERVIEW
Erich Richter, M.D., a neurosurgeon from LSU Health Science Ctr., discusses a new option for patients with severe headaches.
Those of us who do not suffer from headaches sometimes think they are not a big deal. Tell us how serious they can be for some people.
Dr. Erich Richter: They can be very disabling. Many people who fail the more benign drug treatment end up on narcotic drug medications. Those are controlled substances. They have a lot of social implications: what you are allowed to do, what kind of work, issues such as controlling motor vehicles, heavy machinery, not to mention addiction and medical problems that can develop from them. It's one of the most common causes for missed workdays and medical disability in the United States. It's pretty serious.
When you first met Suzette, what kind of problems was she presenting?
Dr. Erich Richter: She had quite a bit of pain related complaints and she'd been through a lot of different procedures. I think she had been in and out of treatment for seventeen years. Her disorder is complex in that a lot of her problems stem from some arthritic type problems in the upper cervical spine. The diagnostic terms for headaches are, what we call, syndrome-based. We don't always know the exact causes of everything, but they still fall into categories according to what hurts and what causes it to hurt and the type of pain. One of the things that made her particular case more complex is that it's not a pure migraine syndrome. You had to come up with a syndrome that would also address the problems in the upper cervical spine that was causing some of her neck pain as well.
So what is this new investigational therapy that you offered her? What is it and what is it designed to do?
Dr. Erich Richter: Well, there is an FDA-approved therapy called Spinal Cord Stimulation and those devices generally are things that we can implant when there's a nerve-mediated pain, a pain that arises from nerve problems themselves, scarring within a nerve, etc. We can produce a high frequency stimulation of that nerve and the way that interacts in the pathways that carry the pain and causes the pain to be processed by the brain. About 80 percent of people can get that pain under control, or at least diminish it by more than half. For most people that's enough to get them going and get them back in the game. The investigational part of it is looking directly at how it relates to headaches. Which as we've found over the last 10 years or so of people looking at this, commonly are caused by nerve problems at the base of the skull as they come up over the scalp. So, the main complex posteriorly are the occipital nerves. There are several of them and then a lot of people have more frontally based headaches that are often times related to the supraorbital nerve which comes out just above the eye. The investigational component, as in medicine many things seem new, but it's not. The fundamental ideas have been used, for example, in the arms and legs since the seventies. The idea of understanding how it relates to headaches and things like occipital neuralgia, transformed migraine, and these types of headache syndromes that have really not had very good therapy. Some people respond great to the medicines, but a lot of people really don't. Looking at how those same ideas apply in this area is relatively new.
So what do you actually do? In her case what did you do?
Dr. Erich Richter: Well, there is a whole series of diagnostic tests working up to it and one of the critical aspects is a diagnostic block. If, for example, the occipital nerve is creating most of their headache problems then deadening or numbing the nerve with medications, like a lidocaine block, will often produce a very effective short-term relief of their headaches,. But you can't come in every few hours and get a block. So that's not really a very good therapy, but it's important information for us. If we can isolate which nerves are, in fact, causing the problem then the next question is: are they part of that 80 percent in which a stimulator treatment will, in fact, produce long-term relief of their headaches? And what we generally do is place a temporary electrode through a needle and they wear that. It comes out through the skin and they try it for a week or so. We call that a trial, a percutaneous trial. And it's one of the few procedures, one of the few surgeries you can basically take for a test drive before you decide to commit to it. And so, we have a pretty good idea before we do any kind of a permanent construct on how well it's going to do in controlling people's pain.
So, what does she have in the back of her neck and her back? What did you implant?
Dr. Erich Richter: If someone has just problems related to the occipital nerve, which is one of the more common issues, we can actually place a small electrode over the base of the scalp and that runs to a pacemaker type device which either can be implanted over the clavicle or actually, in the upper part of the back. In her case, she had a lot of problems related to some arthritis changes at the upper part of the cervical spine, the neck. And because of that, in order to get this lower pain down, we actually had to do a somewhat more extensive procedure where we actually exposed the upper two cervical vertebrae and passed a pair of electrodes, called paddle electrodes, they're more like sheets of electrodes, backwards down the spinal canal and connected that to the pacemaker device. It's called a retrograde C1-2 sublexsiminal implantation.
So how does it work for her? How does she use it?
Dr. Erich Richter: There was a period of programming lasting most of the first month where we had to work through the electrodes. There are 16 different electrodes on those sheets and so which ones you turn on, which ones are positive, which ones are negative, effects the shape of the electrical field that's interacting with the spinal cord and the nerve roots. Her main problems were a headache syndrome, headache pain that would radiate up around the back of the head, and the important part that we need to treat for that is the C-2 nerve root that's coming off to the side at that level. You have to use some electrodes out at the edges to capture that and then she'll get a tingly feeling in through her scalp that, in her case, is extremely effective in controlling the headache pains. Whenever she feels the headaches come on she turns that device on to that program and she'll get what's call a paresthesia, that tingly feeling, and it's very effective in controlling the headaches. The other part of her syndrome, and the reason that we used a little bit more complex electrode array, is that she had a lot of mid-line, neck pain that really didn't have any other surgical treatment and so on those same sheets of electrodes, very high and towards the center there are some electrodes that can produce that same kind of tingly feeling down further into the neck. She's been able to find that that really produces a lot of relief of the muscle related pain, allows the muscle spasm to relax and, as she'll describe it, once a lot of that muscle spasm and that tension that she was holding in largely resulting from the headaches resolved, she actually found that her lower back pain started to slowly improve. We certainly don't tout this as the treatment for all kinds of pain. It is directed at the headache and then if we do the slightly more elaborate version we also can capture some neck and arm problems in those same patients when they overlap. But, we certainly do see that if you can control the major source of a patient's pain that many of those patients over a period of months also find that they're moving better and that as they move more normally and the muscle spasm subside that some of their other back pain type problems also resolve. They get more active.
You talked about the tingling. Does the tingling mean the stimulator is doing something to the nerve?
Dr. Erich Richter: Yes. A nerve works by firing what's called an action potential. So, whatever that nerve is set to sense, when it happens a pulse of electricity goes up the nerve. We're skipping that. We're going straight over the nerve regardless of where it went and electrically turning those fibers on and sending pulses up that nerve to the brain. The reason it feels like a tingly type feeling is that it's a nerve that goes to that area and is supposed to carry feeling, but since we are using electricity to randomly turn those fibers on in a random pattern that's not a natural feeling and the way it interprets it is this buzzing… is the word people often use. Everyone describes it a little different.
But it relieves the pain?
Dr. Erich Richter: About 80% of the time which is why we do the trial. That's why we do a test electrode. I don't have an excellent diagnostic test to pick out the 20 or maybe even the 30% of the people that it's not going to be helpful for. We do a temporary version as an out-patient, very simple procedure through a needle we put in a temporary version and it gives them a pretty good idea of what it's going to feel like and, if they're in the majority that it helps then we go ahead and we put them through the real surgery to put in a completely implanted system. People have lots of questions and they're very understandable. "You're going to put a computer in my body?" "Is this going to hang out?" "Can I still swim?" "What about airport security?" The companies that make the pacemakers make these neuro-stimulators. They're the same technology as the cardiac pacemakers. I usually find that it's easier for the patients to get their head around it to just talk about it as just neuro-pacemakers. It's very well developed technology at this point. Some of them are MRI compatible even. All of them can go through any kind of security system. You can go swimming. It's completely inside. The skin is closed. One of the technological advantages over the last five to ten years is that these kinds of pacemakers are made rechargeable. It used to be that when they wore out you had to come back for a quick surgery to get the battery replaced. Which was not a big deal if it was taking care of your pain. You're usually happy to do that. But it's nice not to have to do that. The only downside to the rechargeable technology is that we do try to leave them a little bit closer to the skin so that the energy can get through and so you usually can see a little faint outline of where the battery is.
FOR MORE INFORMATION, PLEASE CONTACT:
Leslie Capo, Media Relations
LSU Health Sciences Center
(504) 568-4806
LCapo@lsuhsc.edu
