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Biotech Science

FDA OKs Brain Pacemaker for Depression 456

Duke Machesne writes "On Friday, the FDA approved a new therapy for the severely depressed who have run out of treatment options: a pacemaker-like implant that sends tiny electric shocks to the brain. The Food and Drug Administration's clearance opens Cyberonics Inc.'s vagus nerve stimulator, or VNS, as a potential treatment for an estimated 4 million Americans with hard-to-treat depression - despite controversy over whether it's really been proven to work."
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FDA OKs Brain Pacemaker for Depression

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  • by Jeffrey Baker ( 6191 ) on Thursday July 21, 2005 @01:31PM (#13126190)
    I don't know about parkinson's, but the same device is used to treat severe epilepsy.
  • by jdehnert ( 84375 ) * <jdehnert@@@dehnert...com> on Thursday July 21, 2005 @01:32PM (#13126217) Homepage
    Can you say Harrison Bergeron? I though you could.
  • Not for everybody (Score:2, Informative)

    by DisasterDoctor ( 775095 ) on Thursday July 21, 2005 @01:35PM (#13126259)
    Please remember that the FDA has approved this device only for treatment-resistant depression. This is not first line therapy.
  • by Pxtl ( 151020 ) on Thursday July 21, 2005 @01:37PM (#13126297) Homepage
    Niven played with this concept a lot too, it appears in an extreme form in many of his novels and short stories. For example, in the Gil Hamilton detective stories, a man is killed by being hooked up to such an ecstacy device through a cord too short to allow him to reach the kitchen, so he starves to death rather than disconnect the device (much of the story debates whether or not this was a suicide).

    Personally, I like Niven's writing better than Crichton's.
  • by Frangible ( 881728 ) on Thursday July 21, 2005 @01:41PM (#13126354)
    The vagus nerve is tenth of twelve paired cranial nerves and is the only nerve that starts in the brainstem (somewhere in the medulla oblongata) and extends all the way down past the head, right down to the abdomen. The vagus nerve is arguably the single most important nerve in the body.

    The medieval Latin word vagus means literally "wandering" (the words "vagrant", "vagabond", and "vague" come from the same root).

    This nerve supplies motor and sensory parasympathetic fibres to pretty much everything from the neck down to the first third of the transverse colon. In this capacity, it is involved in, amongst other things, such varied tasks as heart rate, gastrointestinal peristalsis, sweating and speech (via the recurrent laryngeal nerve).

    The vagus also controls a few skeletal muscles, namely:

    * levator veli palatini muscle
    * salpingopharyngeus muscle
    * stylopharyngeus muscle
    * palatoglossus muscle
    * palatopharyngeus muscle
    * superior, middle and inferior pharyngeal constrictors
    * muscles of the larynx (speech).

    This means that the vagus nerve is responsible for quite a few muscle movements in the mouth and also is vitally important for speech and in keeping the larynx open for breathing.

    It also receives some sensation from the outer ear and part of the meninges.

    The vagus nerve and the heart

    Parasympathetic innervation of the heart is mediated by the vagus nerve. The right vagus innervates the SA node. Parasympathetic hyperstimulation predisposes those affected to bradyarrhythmias. The left vagus when hyperstimulated predisposes the heart to AV blocks.

  • by Rosco P. Coltrane ( 209368 ) on Thursday July 21, 2005 @01:47PM (#13126451)
    isn't this the same treatment for severe cases of Parkinson's?

    No, the device you're thinking of is the thalamic stimulator [wikipedia.org]. It's implanted in the brain, with the patient conscious, and I read somewhere that the results are dramatic, so much so that surgeon looks at the patient's hand, probes on the thalamus with the electrode to find the right spot, and when he finds it, the shaking instantly stops. I hear when the implant is in place and working, the only reminder of Parkinson's disease left is slowness of movements, but no more tremors.
  • by Andronoid ( 816502 ) on Thursday July 21, 2005 @01:49PM (#13126481)
    Because randomly stimulating a single nerve tract to cause the release of neuro -ransmitters is easy while the more precise stimulation needed for perception is very hard (and almost not at all understood). For those unfamiliar with neuro-anatomy the vagus nerve goes throughout the body and (primarily) picks up signals on heart rate etc. that are associate with an increased level of arousal. This nerve projects (again primarily) to the amygdala the brains "emotional center" so your brain knows your scared, excited, elated or any other state of high arousal (because often your body reacts before your brain does, altough this is a simplistic explanation) So all this device seems to do is cause a higher level of arousal. It doesn't seem to do much more than current drugs already do, except maybe that the level of control is more precise than just popping a pill.
  • by nyrk ( 779328 ) on Thursday July 21, 2005 @01:50PM (#13126497)
    Actually the tasp was the remote version of it, so you could "Make someone's day" by remotely You are thinking of a droud.
  • Instead of FUD... (Score:5, Informative)

    by Jurph ( 16396 ) on Thursday July 21, 2005 @01:52PM (#13126527)
    How about some more factual information? NPR [npr.org] has done several [npr.org] stories [npr.org] on this kind of treatment, and how it is (and isn't) used. This is not "rats push the button to feel good". This treatment involves a very precise electrical impulse delivered to the malfunctioning area of the brain; it is to electro-shock therapy what a bonsai knife is to a lawnmower, so the side effects, while not well-characterized, are likely to be orders of magnitude less intrusive.

    It's used in cases where the depression is not treatable with current drugs. These are people who are so seriously neurochemically depressed that suicide seems attractive for the relief it would offer. The best we could give them before was a hug and a doctor mumbling that they were "interesting," until eventually they gave up and killed themselves. Now we can offer them this, which has at least one major advantage over suicide.
  • by bedroll ( 806612 ) on Thursday July 21, 2005 @01:57PM (#13126618) Journal
    Hello, boys and girls. This is your old pal, Stinky Wizzleteats..
    A better reference [lysator.liu.se]:
    Stimpy's Invention

    Stimpy invents lots of silly things and has Ren try them out. Ren is not happy with these inventions, so Stimpy makes a "Happy Helmet" to make sure Ren is never unhappy again. The result is even more psychotic than "Space Madness." Includes the now-famous "Happy Happy Joy Joy" song.
  • by sczimme ( 603413 ) on Thursday July 21, 2005 @01:59PM (#13126651)

    Can you say Harrison Bergeron? I though you could.

    You could say that, but you would be wrong:

    - The handicap helmet George Bergeron wore in the essay emitted sounds, not electric shocks.

    - The helmet was designed to keep George down, i.e. to disrupt his brain/thought patterns, not to resolve any problem he might have had (unlike the device in the article).

    One of many places to read Harrison Bergeron in its entirety. [westvalley.edu]

  • by adagioforstrings ( 192285 ) on Thursday July 21, 2005 @02:07PM (#13126767)
    Ah, the Wire. [wireheading.com]
  • by venicebeach ( 702856 ) on Thursday July 21, 2005 @02:09PM (#13126796) Homepage Journal
    Yes, what the grandparent is probably thinking of is a deep brain stimulator [wikipedia.org], where an electrical device delivers stimulation directly to the brain, usually in the thalamus or globus pallidus. A vagus nerve stimulator is not implanted in the brain, it's implanted in the chest and stimulates the vagus nerve, which is a peripheral nerve that carries sensory information to the brain from the viscera.
  • by venicebeach ( 702856 ) on Thursday July 21, 2005 @02:54PM (#13127396) Homepage Journal
    Define 'insane'?

    Tom Cruise.
  • by hackstraw ( 262471 ) * on Thursday July 21, 2005 @03:04PM (#13127510)
    The idea of depression being "due to a problem with the brain" is something of a misconception; of course it is one that has been promoted and reenforced by pharmaeutical companies.

    Although I would love to agree with this, having issues with depression for over 20 years, I believe that I know a thing or two about it.

    I have bipolar disorder (aka manic-depression), and I do need to be on medication to control it. I cannot say that situational events outside of my brain chemistry have no effect on my mood like anybody else, however I do go through distinct mood swings, even with medication.

    A brief description of bipolar disorder goes like this -- Depression is the underlying issue for both the depressive side (duh) and the manic side. This is from what I understand, and it matches my experience as well, the manic phase is due to a biological reaction to being so depressed for an extended period of time. I compare it to anorexia-nervosa. There is an ironic characteristic with anorexia where the body goes into hyper mode after dropping below a certain level of fat tissue in the body that puts the body into "flight" mode. Biologically, one theory behind this is that it is a survival trait that when the body is without adequate food for a certain time, the body goes into overdrive so that the individual can have the energy to relocate and get food and survive.

    Granted, I don't believe that there is much of a survival aspect with being manic as with the anorexic, but mania does appear to be a reaction to being depressed for an extended period of time. In fact, if I only take an antidepressant without a mood stabilizer as well, I will go into a manic phase fairly shortly.

    I would love to be free of medication, the responsibility to take it, its cost, and the side effects, but I have come to accept that the positives of taking the meds outweighs the negatives. Now, its not like if I stop taking my meds I will be in a bad state within a week to two. It could be up to a year, depending on other things. Its a matter of when, not if.

    I will say that being depressed sucks. In itself, being depressed is depressing. I loose interest and motivation to do things. I don't care about much. I can get into a compulsive work mode in an effort to make myself feel better, but it really only keeps my mind off of things. I get this empty bottomless pit feeling in my gut, and I simply do not feel good. I don't want to be around people or go out, I would rather just sit in my misery. When I'm very depressed, I can hallucinate a bit.

    Now, being manic can be fun to an extent. The best way that I can explain it to most people is that it is like being on LSD for weeks or months at a time. I have gone without sleep for a good part of 2 weeks. I can get into very interesting sexual situations. I'm slightly psychic. I have very racing thoughts and mood swings throughout the day where I'm irritable and cranky to full of life and the life of the party. I have the attention span of a fly. Its almost impossible to do something like read or anything else where I have to sit still for an extended period of time.

    I will also mention that I know a few people with my disorder as well. I'm unsure if anybody has it as severe as I do. As far as the manic-depressive scale goes, I'm off the charts. The most extreme manic swing is characterized as having psychotic features (manic psychosis, I believe) and that is where I have been, although not in years. Also, its worth noting that every time an individual goes through a manic episode, it impairs the person even further each time. I've seen an older woman that was bipolar that I believe (and the court believes) that she will never be able to function on her own.

    Now, back to the skeptical view. I do believe that depression is over diagnosed and I find it difficult that humans have evolved over the years into a more depressed group of people. It does not biologically make sense. Aside from some benefits of be
  • by exp(pi*sqrt(163)) ( 613870 ) on Thursday July 21, 2005 @03:15PM (#13127679) Journal
    ...info copied wholesale from Wikipedia, and largely irrelevant to the story, really ought not to be modded up.
  • After seeing the flood of speculation and information based misunderstanding so endemic to a /. discussion, I thought I'd add a personal comment.

    My brother is 45 years old, and has had severe epilepsy since he was 3 years old. He is also learning disabled and orthopedically handicapped. Epilepsy, as you may or may not know, is the brain's equivalent of a 'lightning storm'. The cause varies, and the most common treatment is a combination of drugs and surgery to reduce either the beginning of the epileptic seizure or slow the propagation of the wave of activity across the cereberal cortex.

    In many patients, drug therapy has to be regularly fine-tuned or completely changed. Think of it as regular security patches, because the brain figures ways to hack around the chemical defenses. In some patients, the brain is so good at hacking through the barriers that drug therapy loses effectiveness. This happened to my brother.

    An FDA approved treatment for patients in this condition is the use of a Vagal Nerve Stimulator (VNS). He has a controller/power source implanted in his shoulder, a wire threaded up inside his neck, and the eletrode implanted next to the Vagal Nerve. This nerve is down in the brain stem / 'hindbrain'. Every 5 minutes the controller sends a signal(started at 250mv, it's up to 500mv) for 30 seconds into this electrode. If we want to, we can command a pulse our of sequence by passing a strong magnet over the controller.

    The results have not been Science Fiction Movie class miraculous, but they have been visible. For the first few days he would physically react to the pulses (facial tick/jerk, shoulder hunch, etc..). After three months, he no longer reacts as visibly.

    But, his grand mal seizure activity has dropped. His petit mal seizure activity has dropped as well. He's improving ! He is more alert, vocal, communicative, and is cracking jokes once again.

    I don't know how it will work on depression, but I can tell you from personal observation that it seems to work for epilepsy !
  • by scottv67 ( 731709 ) on Thursday July 21, 2005 @06:45PM (#13130122)
    It's so effective that patients often want to undergo the same treatment if their depression returns.

    Unless you have first-hand experience or can provide links to reputable medical sources, I call bullshit.

    Never use "ECT" and "effective" in the same sentence.

    Anyone who would "agree" to ECT twice probably doesn't have enough brain left to decide what is best for themselves.

    I hope I live long enough to see ECT made illegal. It's this generation's "eugenics". That practice was legal at one time. But once the Nazis adopted it, it quickly became taboo. I hope something similar happens with ECT. It would be a very good thing if the only way our grandchildren found out about ECT was in their medical history books.
  • by texas neuron ( 710330 ) on Thursday July 21, 2005 @07:13PM (#13130321) Homepage
    Just to provide some background for readers. The vagus nerve stimulator is implanted in the chest and has wires that leads to the left vagus nerve at the neck. The left vagus nerve was chosen because it was felt to be less likely to affect the heart rate. The device is programmed to deliver impulses on a fixed timing system (30 seconds on, 5 minutes off is one common setting). When used in epilepsy, a second program can be activated by a magnet to stop the seizure when it has already started either by the patient or by a family member. How the device prevents seizures is not clear. During a seizure it probably works by helping to desyncronize the cells of the brain. It is groups of cells firing improperly together that creates the seizure. More on the VNS can be read on my web site here [loftusmd.com]. Physicians treating epilepsy patients noticed mood improvements and the studies to look at depressed patients were started.

    Because of the high cost of the device (cost of device, implantation, and programming) the studies in depression have been limited to those patients who have been resistant to multiple depression treatments. That is why when it was approved by the FDA, the patients it was approved for was also limited to this group. This group of patients, are, however, often hospitalized and therefore this treatment could prove to be cost effective. Since psychiatry is not my specialty, neurology is, I have not kept up as much with its use in this area.

    The deep brain stimulator is located in the chest and it wire connect to a lead that is placed in different places within the brain depending on the condition being treated. The most common diseases treated with this device is Parkinson's disease and severe essential tremor. Most patients require 2 of these devices (one for the left brain and the other for the right brain) The device is quite effective and greatly improves the quality of life of these patients. In the case of Parkinson's disease, the disease unfortunately continues to progress.

  • by cluckshot ( 658931 ) on Thursday July 21, 2005 @07:14PM (#13130333)

    First as an RN who has been present (not treated but watching and post TX caregiver) for ECT. It is a horrid failure. However some vagal nerve stimulation might be of some value. It could hardly be less effective than most of the so called treatments of today. SO MOD this parent up those of you who are mods! If you don't like this post get a life mods!

    The FDA studies on this reveal the treatment is of very little if any value. So that makes it light years ahead of the various MAO non-MAO etc Tri-... etc treatments which in a matter of months or years leave the person with a whole complex of debilitating neurologic damage which is perminant or Prozac types which make the person likely to become homicidal and suicidal in too many cases etc. With this all said... I have a strange suggestion for this device. It probably if placed correctly would be an effective treatment for Sleep Apnea.

    Heads up you research types. Sleep Apnea represents a suppressor signal in the brain which normally applies to suppressing voluntary activities that has become misdirected to the suppression of the muscle tension in the upper airway and to varous respiratory control centers. This is a candidate begging for this type of treatment.

    I have sleep apnea. I know. I have no trouble sustaining my breathing pattern or airway conditions until I fall asleep. CPAP may hold the area open but it would be much nicer to have a little nerve stimulator implanted and have it detect the lack of a signal and to supply it locally.

    The good news here is that the FDA when it allows such a device allows it out and it can be applied "off Label" so this can get going now. I am sure that other good uses of such devices exist. Depression however is probably the least likely to apply.

  • by ylikone ( 589264 ) on Thursday July 21, 2005 @09:23PM (#13131122) Homepage
    you are only talking about situational depression, which everybody gets sometimes in their life. clinical depression is an imbalance of chemicals in your brain, making you be depressed even when everything is great in your life. you obviously do not know any clinically depressed people and you haven't read any medical books on the subject. don't try and tell people you have an answer... you will only make things worse.
  • by maxpublic ( 450413 ) on Thursday July 21, 2005 @09:49PM (#13131312) Homepage
    there is no PET scan or any kind of thing that would tell you definately, 'this person has depression'.

    I don't see your point. It's possible with imaging technology to see chemical changes in the brain associated with certain behaviors. Severe depressives have a markedly altered brain chemistry that sets them apart from people who're just plain ol' depressed. They're even more distinguished in that the radical imbalance lasts for inordinate periods of time.

    You can correlate these two things, just as you can use a PET scan to identify classical schizophrenia.

    Severe depression IS a biologically-based disorder, just as schizophrenia and severe OCD are. All of these things stem from a malfunction, genetic defect, or outright brain damage. You CANNOT 'cure' severe depressives with therapy any more than you can cure appendicitis by chatting about it with your doctor.

    The brain is an organ like any other. And it can be damaged like any other. To think that you can 'talk' someone out of a physical dysfunction is ludicrous.

    Max
  • by maxpublic ( 450413 ) on Thursday July 21, 2005 @11:34PM (#13131916) Homepage
    Try "pet scan mood disorder" on Google. Go ahead, knock yourself out.

    Max

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