The Safety of TDCS

About 15 years ago, when I was deep in my studies to become a Doctor of Naturopathic Medicine (I have a medical background, but now I am an EE, and hope to be a successful businessman in a few years time…) my daily experience was immersed in my studies and my colleagues. The subculture would deceive where we truly were: common health problems were low cholesterol and fatigue, there was little obesity, pharmaceuticals as intervention were only the very last resort. This is the perception I have to be aware of when thinking of the safety of TDCS.

I have been an active participant in DIY TDCS for about two years, initially just practicing, then becoming a little more vocal. And in that community the safety of TDCS is so wholeheartedly believed, known, that there is definitely a risk of accusation if speaking otherwise. But then I step out into the “real world”, with scary descriptions and still the “don’t do this at home” mentality. It is important for someone to have this perspective, it is a new technology and there are still questions, but using scare tactics to disregard the technology, or to mock it, or to attempt to slow its dissemination into the general public is foolish, and maybe immoral.

 

In the research community, the message is similar to the DIY (and much more complicated to read) but definitely more tempered. The work is there: a systematic review on the adverse effects of TDCS found pretty much the same as all the others (39% itching, 22% tingling, 15% headache, 9% burning) (Brunoni 2009). Other papers have similar adverse effects, I have also seen fatigue, the percentages are different, but the adverse effects are similar (a list of some papers below). To be straight, the research is on commercial devices (but not those designed for TDCS), with experienced research personnel running the studies. Not just putting a 9V battery on the head.

But that is the crazy thing about TDCS. People, most likely in the thousands, are putting 9V batteries on their head (hopefully at least through a couple resistors and good electrodes), as well as designing and building simple current regulating circuits to produce real, effective TDCS devices. And the consequences? I have certainly read examples of people saying it is greatly helping with their medical condition, helping them pass exams, learn languages. Is this scientifically proving TDCS, hell no, it is more exciting. It is the beginning of TDCS as it is disseminated through the greater population; psychonauts performing the long term experiments of TDCS that is lacking in the research. These are people experimenting with poor equipment, perhaps making mistakes in their designs or builds, with varied medical conditions, varied personalities (and maybe personality disorders) and the disasters have not occurred (fingers crossed). But despite the scare tactics they are taking the chance and striving nonetheless to better themselves. This is the exciting part.

Arul-Anandam AP, Loo C, Sachdev. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? Medicine Reports 2009, 1:58

 Bikson M, Datta A, lwassif M. Establishing safety limits for transcranial direct current stimulation. Clin Neurophysiol 2009;120(6):1161

 Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A Systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsypharm 2011;14:1133-1145

 Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wasserman EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology 2005;64:872-875.

 Nitsche MA, Liebetanz K, Lang N, Antal A, Tergan F, Paulus W. Safety criteria for transcranial direct current stimulation in humans. Clin Neurophysiol 2003; 114(11):2220-2. 

 Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of tDCS concerning healthy subjects and patients. Brain Res Bull 2007;72:208-214.

The Plato PTSD TDCS Study

Human Bioelectric is excited to announce that we have been developing a hand-held, cognitive enhancement device based on the TDCS technology. TDCS is slowly moving out of its early research stage, and brave early adopter stage where the psychonauts of today do a little research, build a device and become DIY TDCS experimenters. There is a sophisticated, complicated commercial device (somehow legally available) but we thought that it is important to make the TDCS device simpler, easier-to-use, have the important safety features, yet supply flexible TDCS requirements. Meet Plato (ok, this is just the PCB but the cover is cool too). 

Plato provides three levels of regulated current (Low (1.0mA), Med (1.5mA), and High (2.0mA) through 2” x 2” sponge electrodes to minimize tingling and the slight burning that can occur with TDCS. Plato also has an over-current protection and a timeout that turns the current off 20min after you start a treatment.

But TDCS devices are not regulated in the US for commercial or even clinical use. Brain centers, researchers, and some DIY enthusiasts are using iontophoresis devices in an “off label” circumstance. But these devices are not made for TDCS use, the allowable levels of current and voltage are higher than a TDCS device, hence development of a simple TDCS device is important.

To develop a medical device, the first step is often a feasibility study. Hence we are very excited to announce that we will be undertaking a study:

The Safety of Anodal DLPFC direct current stimulation on the PTSD population, a feasibility study for the Plato TDCS device.

Surprisingly there has been little research into using TDCS for the clinical condition of Post Traumatic Stress Disorder. In the research you can find TDCS benefitting depression, chronic pain, improving concentration, and even the down regulation of negative emotional conditions, all of these crucial symptoms in the battle of PTSD. For these conditions, many of the studies use Anodal Dorsolateral Prefrontal Cortex (DLPFC). Hence we will be performing a small study, about 20 people, in the Portland ME area, receiving Anodal DLPFC over a four week period using Plato to provide the TDCS. The study outcomes will be questioning the safety and side effects of the TDCS treatments showing similar results to other TDCS safety studies. But any benefit to the study participants will occur. More details of the study to follow.

And lastly to fund the study we will be starting an Indiegogo campaign in April. More information about Plato and the Plato PTSD Safety study can be found at the website:

www.humanbioelectric.com

And you can stay in touch by following our Facebook or Google+ page.

https://www.facebook.com/pages/Human-Bioelectric/179428562206417

https://plus.google.com/u/0/108728310407483708982/posts

Everybody’s help will allow us to open an important new tool in the treatment of PTSD and inch forward the regulation of TDCS through an inexpensive easy-to-use device.