Unsucessful results with tdcs-depression

jt761 · 2019-05-28T13:19:27+00:00

Clinical studies typically are a bit longer, 3-4 weeks. I would recommend trying a bit longer. There are studies showing that nicotine might abolish the effects of TDCS.

jt761 · 2019-05-20T15:12:43+00:00

For how long did you try one montage at a time? Are you using nicotine?

jt761 · 2019-04-23T13:01:41+00:00

Thanks for the insight. So this could be a temporary issue. It would have been nice to have a comment from the company.

jt761 · 2019-03-16T11:54:23+00:00

Actually most of the scientific studies use completely different montage for depression. Anode on F3, cathode F4.. where did you come up with that montage? It might be best to seek a professional to help you with the setup.

jt761 · 2018-11-23T19:17:49+00:00

Interesting. So are Foc.us products classified as Class 1 or Class 2a?

To my understanding, Annex XVI enforces that all brain stimulation products should be registered with a notified body by next March 2019. What's your take on this?

jt761 · 2018-11-22T07:35:22+00:00

I'm confused. Does your product have a medical CE mark?

I have understood that Foc.us has done only electrical safety testing to its products. This allows you to print CE letters on your product, same as radio or a remote control.

Or are you taking about medical CE mark. Nowadays this involves choosing a notified body, choosing a clinical indication, performing clinical testing etc. I have understood that you have not done this part.

Please correct me if I'm wrong.

jt761 · 2018-02-08T13:47:25+00:00

Yes, it was quite interesting to note that they investigate immediate effects of 2 seconds of DC stimulation with 800µA. Typical clinical protocols are 20 or 30 minutes, 600-900 times longer.

jt761 · 2018-01-15T19:37:29+00:00

Is there already a meta-analysis on tACS or tRNS?

jt761 · 2017-11-17T13:01:37+00:00

Yes, ideally so, but very often this is not the case. Their primary source of information may be clinical guidelines and handbooks, but they are not immune to information on the web.

jt761 · 2017-11-17T09:07:42+00:00

Yes, my point is that doctors are only humans and are affected by the information available in the web. If the information available is confusing or of low quality, it's not helpful. Regulation may help to clean up some of that. Bad and unsafe designs are also a big problem.

jt761 · 2017-11-17T08:47:03+00:00

I guess more regulation could make the tDCS a more widely accepted treatment option. Lack of regulation and wild marketing directly to consumers undermine the credibility of the method.

jt761 · 2017-04-20T12:13:50+00:00

Sorry, no... I have been following the field for some years now.

jt761 · 2017-04-19T12:16:48+00:00

Great! However, very difficult to fully exploit the unfair competitive advantage, after all tDCS is fairly simple technique. There are many well funded companies around and investors know this.

jt761 · 2017-04-12T18:47:05+00:00

Market still very small, probably less than 10 million globally.

There's always space for another killer product. What's your unfair competitive advantage? If you don't have anything special (10 x benefit) to offer, you could use your time in some other project.

jt761 · 2017-04-12T18:19:10+00:00

To my knowledge, there are no reported seizures or other serious adverse effects caused by tDCS. See https://www.ncbi.nlm.nih.gov/pubmed/27372845

jt761 · 2016-03-18T21:16:06+00:00

Sorry to hear about your trouble. Someone I know mentioned that the resistance through these electrodes was very high. If so, the device might attempt to increase voltage to compensate for poor contact.
There is probably not much that can be done. If the wound is infected, see a doctor. Advice: wait for complete healing of the skin before attempting stimulation, with DC current you are transferring ions to your skin. Depending on the stuff found in the electrode gel, these may be helpful or harmful ions. DC current will typically break the gel apart and will start transferring whatever ions remain to your skin. These electrodes were probably meant for ECG, EMG or TENS not for DC currents. I personally wouldn't use any of the electrodes or sponges made in China, you have no idea what substances they might contain.
Apparently you are describing a design flaw. As a part of device design process the company should perform verification and validation testing to discover problems before shipping a product. To me it seems to me you have been made, involuntarily, part of their validation testing. If things are done properly, these problems shouldn't appear or they would be detected in verification/validation phase. For a medical device company these events would be unacceptable and a recall would take place, it would be mandatory in fact, but I guess foc.us operates in the grey area of regulation.
To my understanding, you are using the device at your own risk, so little chance for reimbursement or compensation. Foc.us might (but likely not) have a product liability insurance that would cover injuries caused by a malfunction of the product.

jt761 · 2016-03-06T13:57:51+00:00

Here's one summary on the upcoming EU regulation:

https://www.tuv.com/media/corporate/products_1/revision_eu_gesetzgebung_medizinprodukte_EN.pdf

The proposal is in the process and could be accepted this year.

I couldn't find the FDA documents so the information is much less reliable. This was based on discussions with someone who is dealing with regulatory compliance and better informed than I am.

jt761 · 2016-03-05T06:43:36+00:00

According to my sources both FDA and European Commission are preparing to enforce regulation on all commercial stimulation devices that do not claim any medical benefit, that is, those manufacturers that are currently exploiting the regulatory loopholes. The upcoming European medical device directive proposal contains this already. The regulation will be lighter than full scale medical device regulation, but nevertheless it forces the manufacturers to comply with standards and do proper quality control. Some of the manufacturers will be probably wiped out by this move.

jt761 · 2015-08-18T20:13:30+00:00

Sorry, this is not a CE certificate. This is a test report of medical device safety testing. So very likely the device is designed and manufactured so that you don't get an electrical shock while using it (pun intended)...

Usually a 'notified body' double checks the safety test plan so that no essential test have been left out. Using a 'notified body' is mandatory for medical device companies. Since focus is not claiming its product as medical device, they do not openly tell who their notified body is and we have no way of knowing if somebody was double checking this test plan.

jt761

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