Why isn't Fisher Wallace Cranial Simulator and similar devices prescribed/discussed more?

[AlfonsTheGuru]

Forgive me if I am posting in an inappropriate forum for this topic; I presume my question would be most relevant here.

I receive psychiatric care myself and I've observed others receive the same treament. Not once have I ever heard of a mental health care professional prescribing a device such as Fisher Wallace Cranial Simulator/similar devices nor discussed this with his/her patients. It is used to treat anxiety, depression, insomnia, and chronic pain such as arthritis by promoting the amount of serotonin (and other neurotransmitters) in the brain through electrical impulses.

According to this article, www.prnewswire.com/news-releases/harvard-medical-school-researcher-publishes-favorable-study-on-fisher-wallace-cranial-stimulator-90606474.html, some "top psychiatrists" (according to the article) indicate an 80 percent success rate. www.fisherwallace.com indicates 2,000+ prescribing doctors and 20,000+ satisfied patients which doesn't seem like a lot.

Here is the a study done by Harvard on Fisher Wallace Cranial Simulator (I did not read this since it is personally very technical for me): https://cdn.shopify.com/s/files/1/0315/7737/files/Harvard_Medical_School_Research.pdf?2806

Why isn't this approach to treating such psychopathies more popular? Could it perhaps be the $600+ cost which Medicare/Medicaid only covers $100 for? Am I missing something?

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[nitemagi]

TCDCS is an interesting emerging intervention, actually with a good heft of research to back it up. Not discussed much yet.

There's uses for refractory depression, refractory psychosis, and even ADHD/improved learning (DARPA has a whole protocol on this).

I don't think Fisher Wallace CS is better than any other.

 

[shan564]

Before I go much further, I want to preface this by saying that the Fisher-Wallace Stimulator uses tACS (transcranial alternating current stimulation), also known as CES (cranial electrical stimulation). This is distinct from tDCS (transcranial direct current stimulation). Fisher-Wallace would like you to believe that they're basically the same thing, since tDCS is much more well-established in the literature on the topic, but they're different.

I co-wrote a review article on tDCS for the Am J Psych residents' journal which just came out a couple of days ago:
http://ajp.psychiatryonline.org/pb/...esidents-journal/2015/October_2015.pdf#page=2
In retrospect, maybe I should have said more about tACS/CES in that article, but I didn't think to mention it because I was trying to focus on stuff that is actually shown to work.

Forgive me if I am posting in an inappropriate forum for this topic; I presume my question would be most relevant here.

We're very careful on this forum to avoid giving medical advice to patients, since we can't give you accurate advice without personally examining you. I'll give some general answers here because neuromodulation is a strong interest of mine.

I receive psychiatric care myself and I've observed others receive the same treament. Not once have I ever heard of a mental health care professional prescribing a device such as Fisher Wallace Cranial Simulator/similar devices nor discussed this with his/her patients. It is used to treat anxiety, depression, insomnia, and chronic pain such as arthritis by promoting the amount of serotonin (and other neurotransmitters) in the brain through electrical impulses.

The reason why it's not commonly prescribed is because it's not FDA approved for anything. The Fisher Wallace people try to trick you by saying it's "FDA cleared," but what that actually means is that the FDA said that they do not need to "approve" or "reject" it because they don't consider it to be a medical device.

According to this article, www.prnewswire.com/news-releases/harvard-medical-school-researcher-publishes-favorable-study-on-fisher-wallace-cranial-stimulator-90606474.html, some "top psychiatrists" (according to the article) indicate an 80 percent success rate. www.fisherwallace.com indicates 2,000+ prescribing doctors and 20,000+ satisfied patients which doesn't seem like a lot.

That press release you cited was written by Fisher Wallace. It has several misleading things in it. They quoted those "top psychiatrists," but when I tried to search for the source of those quotes, I didn't find any such references aside from "quotes" listed on Fisher Wallace's own website. Also, one of those two "psychiatrists" (Richard Brown) isn't actually a psychiatrist, he's a psychologist who is known for touting questionable alternative treatments. The other one (San Martin) doesn't do any research on electrical stimulation of the brain, and doesn't say anything about it in any of the information on his own website or his own publications.

Here is the a study done by Harvard on Fisher Wallace Cranial Simulator (I did not read this since it is personally very technical for me): https://cdn.shopify.com/s/files/1/0315/7737/files/Harvard_Medical_School_Research.pdf?2806

The study is by Felipe Fregni's group. He is a leading expert on electrical/magnetic brain stimulation, and I'd believe anything that he says. But unlike what this press release would like you to believe, it is not a study on the Fisher Wallace stimulator. They would like you to believe that it is, but that statement is misleading the way they write it. They say that the study "involves" their stimulator and discusses "the brain stimulation technology used by the Fisher Wallace Cranial Stimulator," but the study doesn't specifically say much about the stimulator itself. It's mostly talking about tDCS, and doesn't say much about tACS/CES.

The press release also says that Fregni said that "The Fisher Wallace Cranial Stimulator decreases the level of neuronal activity in the motor cortex, a strong indication of why the device may be effective in some conditions with high cortical activity levels such as anxiety." But there is no such statement in the study. The only time they directly mention the Fisher Wallace stimulator, they say the following:
"Since the 1960s, a series of studies with low-intensity AC stimulation have been published (Kirsch and Smith 2004; Smith 2007), and cranial AC stimulation devices have become commercially available for personal use (e.g., Alpha-Stim, Fisher Wallace Cranial Stimulator, Transair Stimulator, etc.). However, research in this area has been inconsistent and there remains a lack of solid evidence showing the effects of weak transcranial stimulation with AC."

The world's leading expert on transcranial electrical/magnetic stimulation is probably Sarah Lisanby, who is the chair of psychiatry at Duke and previously founded the brain stimulation division at Columbia (I'm mentioning this because the press release specifically cited Columbia). Here's what she said in a recent article about the topic:
"Little consistency exists in the literature surrounding the specific parameters and electrode placements used, and there are no controlled trials on its use, making it difficult to draw conclusions about its potential value. In their meta-analysis, Klawansky et al (1995) concluded insufficient controlled evidence existed and that available evidence was probably not adequately blinded."
And here's the source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3238088/

Why isn't this approach to treating such psychopathies more popular? Could it perhaps be the $600+ cost which Medicare/Medicaid only covers $100 for? Am I missing something?

Yes, you're missing something. I'd be much more inclined to believe Fisher Wallace if they didn't show a consistent pattern of misleading claims/statements. I am a big fan of brain stimulation, but because of companies like Fisher Wallace, doctors generally are skeptical of the types of brain stimulation that actually work.

As for tDCS - I do think that this is a useful thing. Still inexpensive, but it has a lot more science behind it than the Fisher Wallace stuff. Fisher Wallace likes to cite the tDCS research as if it supports the use of their stimulator, but there's no science to say that this is accurate.

As for FDA approval - the tDCS literature has grown quite rapidly, and the FDA is having an open meeting in about a month to discuss this in more detail with researchers/psychiatrists.

TCDCS is an interesting emerging intervention, actually with a good heft of research to back it up. Not discussed much yet.

There's uses for refractory depression, refractory psychosis, and even ADHD/improved learning (DARPA has a whole protocol on this).

I don't think Fisher Wallace CS is better than any other.

Let me reiterate that the Fisher Wallace stimulator is NOT tDCS. It is probably inferior to tDCS.

 

[birchswing]

I don't by any means live in a happening area (as in we don't have "top psychiatrists"), and I've seen TMS (transcranial magnetic stimulation) offered at university hospitals a couple hours away from me and at a couple of private outpatient clinics closer by. I'm not sure how it compares to the technique tDCS in effectiveness, but it was quite heavily advertised on the practitioners' web-sites who offer it. I never looked into it further as it was only described as being helpful for depression. I also get suspicious of doctors who invest in something and then seem to want to get as much money out of it as they can (as in TMS is the prominent thing being advertised on a practitioner's web-site, like it's their specialty). That's probably not a fair assessment as they're probably just excited about it.

 

[MacDonaldTriad]

The FDA keeps all of us in check about our inappropriate enthusiasm for this stuff. The only group more frustrated than the physician providers who promote innovations are the recipients of this care. Even with the best intentions, it is true that the FDA is over all more of a blessing than a curse. 99% of these things come and go, but most of us will be guilty of not supporting the few break through exceptions as quickly as the foresighted supporters of successful innovations. Of course 99% of those too fast to support the latest fad will be guilty of having false hope, but no one writes about them.

 

[shan564]

I don't by any means live in a happening area (as in we don't have "top psychiatrists"), and I've seen TMS (transcranial magnetic stimulation) offered at university hospitals a couple hours away from me and at a couple of private outpatient clinics closer by. I'm not sure how it compares to the technique tDCS in effectiveness, but it was quite heavily advertised on the practitioners' web-sites who offer it. I never looked into it further as it was only described as being helpful for depression. I also get suspicious of doctors who invest in something and then seem to want to get as much money out of it as they can (as in TMS is the prominent thing being advertised on a practitioner's web-site, like it's their specialty). That's probably not a fair assessment as they're probably just excited about it.

TMS is more well-established than tDCS. It is actually an FDA-approved treatment for major depression, unlike the other things that have been mentioned in this thread. It is about as effective as SSRIs, but the people who respond to TMS are not the same as the people who respond to SSRIs, so SSRI failure does not necessarily predict TMS failure.

 

[ADDaptogen]

Just want to correct what I believe to be an error. Shan 564 writes that Richard Brown is not a psychiatrist but is actually a psychologist. My understanding and my Google search shows that he is a medical doctor. "He completed Psychiatry Residency and a fellowship in Psychobiology and Psychopharmacology at New York Hospital...." He does practice on the cutting edge and is very highly respected in some circles.
My personal experience with Alpha Stim, tDCS, and Fisher Wallace (tACS) is inconclusive.

 

[whopper]

I've prescribed Alpha Stim to perhaps about 15 patients.

For the most part it's worked well. I've tried it on myself cause I decided to buy a machine so the patients could try it in my office. After a 1 time use I slept much better for the next 2 weeks. I fell asleep faster, but mind you I didn't have a sleeping problem to begin with, but sleeping within 5 minutes vs 15 minutes, well that was nice. Also waking up and feeling more rested than usual was nice too.

It doesn't work on everyone. I haven't exactly counted about about 1/4 of the patient told me they didn't find it helpful while the rest got at least some benefit.

I also noticed that it's the patient with anxiety that want to give it a try more likely because when I have patients try it in my office the anxiety benefit can be immediate while the depression benefit, like an SSRI, can take weeks.

A typical scenario is I'll have a patient with bad anxiety, I tell them to try the device and within minutes they often times do feel much more calm. There are of course a few where it doesn't work at all, but the ones where they feel an immediate effect usually want me to prescribe it despite it's hefty price tag.

The Alpha Stim device is more expensive than the Fisher Wallace device, but I've only had 1 pt try that one and he wasn't pleased with it. It might've been his own fault but he told me getting it wet and setting it up was too much of a pain in the butt while none of the Alpha Stim patients complained of their device.

 

[WisNeuro]

I've prescribed Alpha Stim to perhaps about 15 patients.

Do you have any reviews on this? Last time I looked at this stuff, there was really nothing out there of any quality that convinced me of its merits. Most of it was 0 control group designs with populations (e.g., fibro, VA) who respond particularly strongly to placebo/Hawthorne effects. Although, last I looked was about 5 years ago, so maybe there's some new data out there?>

 

[whopper]

There are studies on it. I don't disagree that you weren't impressed with what you've seen but I don't know what you read.

Again I have tried it on myself and did feel a sleep benefit. I also tried it on a few patients and had the results mentioned above.

I am already convinced it works for some people. I've seen people have panic attacks put on the device and their anxiety goes down to the point where they stop having somatic symptoms in front of my eyes.

 

[WisNeuro]

Well yes, the power of belief can be strong, I don't deny that. There are many sham interventions that "work" nearly instantly. I'd just like to see more quality research on the matter. I'm willing to change my mind if the evidence is there, but the early evidence was poor, at best.

 

[thoffen]

The placebo effect of devices is greater, that's for sure. But I don't think that placebos are necessarily bad medicine. Personally it's something that I was exposed to as an afterthought in residency in a couple lectures without much detail and, of course, the quality of study design is never going to produce the kind of data we all want to look at before signing off on something. But these devices are FDA approved for personal use and not all too expensive. I doubt there is going to be enough incentive for that kind of data to ever be sought. So, despite this post sounding like a marketing pitch, it's something I think worthy of considering. For some of my patients, I just want them to be better, and I'm no purist about the placebo action. From a different perspective, one might see the placebo effect actually resting with the provider and not the treatment. The sugar pill or device or whatever could simply be a transitional object. And such a transitional object may be required.

 

[WisNeuro]

I can think of less expensive placebos, and free lifestyle interventions that will actually lead to lasting change. I'd rather spend my energy and MI skill son those rather than shill something for which I have no idea if it works or not.

 

[whopper]

True. Could've been placebo effect.

BUt I can tell you this. If it's a placebo effect it's one where some patients were able to get off of some their meds and some of them even said they're doing fine on it all by itself and didn't have to see me anymore cause they don't need any more meds.

That still could be placebo effect.

For that reason and because the thing's darned expensive I don't encourage anyone to buy it. I tell them to give it a trial run (they offer a 1 month trial). I also don't offer it first line, unless the patient is in the middle of some horrendous anxiety so I offer them to try it in the office at that moment and if they feel a tremendous benefit and ask about it I'll answer questions about it.

 

[WisNeuro]

I get the sentiment behind it with patient care, if it's a pure placebo, it's not the only placebo we readily recommend in mental health care and otherwise. I am just genuinely curious as to the outcome literature. Sometimes things that seem like snake oil, are just that, and sometimes they actually pan out. On the flip side, some things that have a great theoretical or working animal model basis, flame out spectacularly in clinical trials. But, as doctoral level professionals, I think we owe it to ourselves and our patients to actually know the literature on things we recommend/prescribe.

 

[birchswing]

I was just reading more about these CES devices, trying to find out how they work and if they're safe.

I came across this in which the FDA had plans to make CES devices Class II rather than Class III:

Federal Register :: Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices

Not sure if that came to pass, as I looked up the Alpha Stim and it requires prescription.

What I find a bit confounding is that it seems like no one knows how it works. There are changes to the electrical waves in the brain and they think there are some neurotransmitter changes, but they don't know which ones. So how can it then be so safe that it could possibly not require a prescription (and already doesn't outside the US)? Are there any long-term studies on its safety over time?

I guess I'm used to seeing much more rigor and caution when it comes to medical claims and safety. The web-site for Alpha Stim practically comes out and says "This works really well for a lot of problems, and it's safe!" That's the opposite of a prescription drug ad you see on TV. What accounts for them being allowed to be more cavalier with this product?

EDIT: I was just wondering: Would the proposed mechanism of action of CES be similar to ECT? Like "ECT-lite"? As far as I can find online, the mechanism of both seems to not be known, but what do you all think?

 

[Amygdarya]

I was just wondering: Would the proposed mechanism of action of CES be similar to ECT? Like "ECT-lite"? As far as I can find online, the mechanism of both seems to not be known, but what do you all think?

I can’t quote any literature on this offthe top of my head (and, like you said,the mechanisms of both are largely unknown), but it doesn’t seem like CES is an “ECT-lite”. For one, for ECT to be effective it requires a generalized seizure of at least some minimal duration, which doesn’t happen in CES. Also, on a more conjectural note, while (reversible) recent memory loss is a fairly common (short-term) side effect of ECT, CES presumably improves memory (at least there are reports that claim that).
I may well be mistaken, but to the best of my understanding the mechanism of CES May be more like those of fDCS and TMS, which are essentially modulation (activation or inhibition) of a limited number of brain circuits (vs. the whole brain being “flooded” with synchronized electrical activity as in ECT).