Asks for Opinion of the Alpha Stim 100
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Q:  Asks for Opinion of the Alpha Stim 100


Dr. Phelps,

Your website is excellent and your information is always thorough and up-to-date.
We value your opinion highly so here's our question:

What do you think of the Alpha Stim 100 (a cranial electroconvulsive stimulation
device approved by the FDA in 2006)?  I have a bipolar 23-year child who has been
struggling since high school and is still unstable despite being on Lithium and
Lamictal and antianxiety medication (a "Benzo" which he dislikes).  I am hoping that
the Alpha Stim may be the wave of future treatment for depression/anxiety, etc.
What do you think?


Dear Mr. M' --

Well, that's interesting. I was not aware it had an FDA approval for any indication. So I went and looked.  I found an
interesting explanation dated 2005 about how the device had been "grandfathered" based on a device that was in use before the 1976 enactment of medical device oversight by the FDA. Consistent with that explanation,  if you Google alpha stim FDA indication , at the top of the list you will find a document on the FDA website, a PDF of a letter from the FDA to Mr. Lewis Ward,  entered into the FDA record October 13, 2006. Consistent with the explanation above, it appears that in 2006 the manufacturer received this letter from the FDA stating that officially the device is similar to a device marketed before 1976.  On that basis, it can be allowed into use without further testing.    Quoting from the letter: "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market." 

Mind you, I am not against anything that works, particularly if it is safe and relatively inexpensive. On the other hand, if we really don't know much about safety; and if the device is not only expensive but has become part of some sort of marketing scheme in which practitioners who use the device can sell it to other practitioners -- as I have personally experienced -- then I think we would all be wise to hold the device to a moderately high standard of evidence for effectiveness. I don't generally rely on "FDA indications" to any degree, because the process of getting an indication in the usual way -- as opposed to the way that the Alpha Stim got one -- requires a whole lot of money invested in research, putting FDA indications out of reach for almost anyone except big pharmaceutical houses. That's a very unfortunate by-product of the process. On the other hand, it is at least slightly misrepresenting the Alpha Stim to trumpet an FDA indication given the way that indication was obtained, as it implies that the device went through the same process that medications with FDA indications went through, right? And that definitely is not the case. 

Of course, if the Alpha Stim meets at least a moderate standard of evidence, we should then let everyone else use the device for a few years and wait to see if some sort of negative effect begins to appear -- just as I do when a new medication shows up. That is the stage at which I think this device sits now. There is preliminary evidence from studies treating pain that the device does really do something, more than a placebo. 

On the other hand, I recently read an interesting article by a fellow named Irving Kirsch -- one of a group of researchers, in this case; his name becomes important in a moment -- comparing an elaborate placebo versus a simple pill placebo. In this case, they used "sham acupuncture" and compared it to a standard sugar pill in patients with persistent arm pain. Sham acupuncture is a well studied procedure in which a needle is applied to the skin but does not puncture it. This has been studied as a "control" condition versus real acupuncture since at least
1998.  Kirsch and  colleagues found that the "medical ritual" (their term) around the acupuncture process was the probable basis for its clear superiority, as a pain treatment, versus a pill placebo.  In other words, the patients who believed that they were getting real acupuncture experienced greater pain reduction than those who received a placebo pill that they thought might be a real painkiller. You can imagine how this might work: the relatively elaborate procedure, compared to swallowing a pill, seems to have more influence on a person's ability to believe that they are receiving a helpful treatment.

Irving Kirsch, Ph.D., who is with the Department of Psychology at the University of Hull, UK has been prominent in the media lately as the lead author of a research study suggesting that antidepressants are no more effective than a placebo for most patients with depression.  This paper was presented on CNN and Forbes the day it was released (I learned about it from people who had seen those programs before I found it listed on Pub Med, the main repository for such papers in the United States.  In other words, someone did a good job at getting this paper in front of the big media.)  This is an important piece of research, mind you.  The implications are profound. This paper will be a touchstone for years, I think, as we try to figure out how best to help people with mood problems.

Interestingly, the founder and chairman of the board of the company that makes the Alpha Stim device is Daniel Kirsch.  Though not related by blood, these two Kirsch's are related in their interests: one Kirsch studies the impact of placebo, particularly "medical ritual" types of placebo, and has aggressively published on this subject over the last decade ( e.g. here is his 2005 editorial on this issue). The other Kirsch makes a "medical ritual" device which because of a grandfather clause has not been subjected to the routine tests the FDA usually requires for approving a treatment -- tests that require comparison with a placebo. 

To his credit, Daniel Kirsch appears to have performed a very careful "placebo control" in his 1981 study of the Alpha Stim device for the treatment of pain.  he gave careful attention to "blinding", such that both the subject and the researchers were kept unaware of whether the device in use was actually transmitting current or not. Unfortunately, in the subsequent years, I still cannot find a similar "blinded", "controlled" trial of this device for the treatment of depression -- including by reviewing the articles the company lists on its website under "research".  Several of the articles they list, when examined directly, are an embarrassment in terms of standards of evidence: most of them are expressions of opinion, not research studies.  One of them is a collection of feedback from people who had purchased the device, 85% of whom report benefit.  If you spent several hundred dollars for a device, might that influence whether or not you thought that it worked, particularly if you took the time and energy to send in the warranty card? This is not reliable evidence.

Your question prompted me to search again for cranial electrostimulation depression on Pub Med.  There is an article from 1991 suggesting some benefit in people who were withdrawing from sleep medications. But otherwise I can find nothing on this technique.  I could be missing something with my search. 

I sent this little polemic to both Kirschs to make sure I have not mis-stated their work. Dr. Irving Kirsch wrote back;  Dr. Daniel Kirsch did not.

For now, I am still awaiting clearer evidence of efficacy for this device -- as its safety is not clear (though it has been in use over 20 years of use, almost all of that use was on other parts of the body, not the brain) and someone is making a lot of money with it. 

Dr. Phelps



Published April, 2008
 

 

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