This instructional video demonstrates the correct way to measure and place electrodes. In a clinical setting, with a medical grade tDCS device (Soterix), a subject is measured for electrode placement on the primary motor cortex. The dorsolateral prefrontal cortex region is also shown. This is the first time I’ve seen the video on Youtube (making it easy to share). Previously it could only be found here, where an associated pdf which includes illustrations is also made available.
This is an incredibly well-researched paper. All the nuance of FDA regulation around tDCS and similar devices is made clear. I’ve been picking away at trying to understand this myself, but had become extremely frustrated by the complexity and opacity of FDA jargon and legalese. Anna has collected all the relevant facts and applied them very close to home citing specific devices and situations the DIY tDCS crowd will be familiar with. Anna Wexler is the author as well of The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals (gated) . She spoke to myself and at least a handful of other reddit.com/r/tDCS contributors for that paper. In both papers she lays out a very sensible approach to regulating tDCS, or rather, not regulating it. Stating that there is already a body of relevant law stemming from various government agencies (in the U.S.) that could be called upon to regulate tDCS device use as needed.
This paper contributes to the literature on the regulation of consumer brain stimulation devices in the USA by providing a fact-based analysis of the consumer tDCS market and relevant laws and regulations. In the first section, I present a short history of the DIY tDCS movement and the subsequent emergence of DTC devices. In the second and third sections, I outline the basics of FDA medical device regulation and discuss how the definition of a medical device—which focuses on the intended use of the device rather than its mechanism of action—is of paramount importance for discussions of consumer tDCS device regulation. I then discuss how both the FDA and the courts have understood the FDA’s jurisdiction over medical devices in cases where the meaning of ‘intended use’ has been challenged. In the fourth section, I analyse the only instance of tDCS regulatory action to date, in which the California Department of Public Health (CDPH) forced a firm to recall several hundred consumer tDCS devices. Although there exists a common perception that the FDA has not been involved with the regulation of consumer tDCS devices, the California case demonstrates that the CDPH’s actions were instigated by an FDA engineer. Finally, I discuss the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices.
| CONSUMER TDCS DEVICE | MARKETING LANGUAGE |
|---|---|
| Brain Stimulator* https://thebrainstimulator.net/what-is-tdcs/ | ‘tDCS allows you to unlock your brain’s true potential’ |
| Cognitive Kit* http://www.cognitivekit.com/ | ‘Charge your mind’ |
| tdcs-kit http://www.tdcs-kit.com/ | ‘Power your mind’ |
| ApeX Type A* http://www.apexdevice.net/ | ‘Be happier. Be focused. Be smarter’ |
| Foc.us* http://www.foc.us/ | ‘make your synapses fire faster’, ‘overclock your brain’, ‘take charge’ |
| Thync* http://www.thync.com | ‘quiet your mind’, ‘boost your workout’ |
| PriorMind http://www.priormind.com | ‘increase your attention span’ ‘tDCS has been widely used to treat depression…’ |
| TCT* http://www.trans-cranial.com | ‘when only the best in tDCS therapy will do’ |
| Super Specific Devices* http://www.superspecificdevices.com | ‘personal tDCS device’ |
*Website contains some form of a medical or health-related disclaimer.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm458018.htm
The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function.
Oxley said a paper published in Nature last year, which showed lucid dreams could be induced through stimulating gamma waves in a sleeping person, inspired a lot of customers to try to use foc.us in the same way. So the foc.us team wrote a new program specifically designed to try to ellicit lucid dreams.
“A positive charge will excite a part of the brain and a negative current will sort of turn off that part of the brain,” Oxley said. “The higher function areas at the front of the brain are active during lucid dreams, so the idea is that if we excite that while people are dreaming, they’ll have a greater chance of having a lucid dream.”
Oxley said he uses the device nearly every night, and while it doesn’t always work, when it does it’s very exciting. Unfortunately, my experience was not quite so thrilling. Though the lucid dream program on the foc.us delivers a relatively low electrical current of 1.5 milliamps, it was too high for me. The electrodes immediately started to sting my skin and I had to take them off after about three seconds. So, I enlisted my less-sensitive coworkers to test it out, but the results were just as disappointing.
Source: We Wore Electrodes to Bed to Induce Lucid Dreaming | Motherboard
An overwhelming amount of tDCS-related information is about to descend upon us.
Neuroscience 2015 will take place October 17-21 at McCormick Place in Chicago. Join more than 30,000 colleagues from more than 80 countries at the world’s largest marketplace of ideas and tools for global neuroscience.
Here’s a small sample of some of the tDCS-related presentations/abstracts that caught my eye. (Unfortunately I can’t link to my search results so I also scraped the page so you can see for yourself here.)
Indirectly related to tDCS but a fascinating new paper attempts to understand how the frontal cortex is responsible for cognitive control.
“Surprisingly,” Bassett said, “our results suggest that the human brain resembles a flock of birds. The flock comes to a consensus about which way to fly based on how close the birds are to one another and in what formation. Birds that fly at specific places in the flock can drive changes in the flock’s direction, being leaders in a so-called multi-agent system.
—–
“We’re very interested in controlling brain networks with techniques like optogenetics, transcranial magnetic or direct-current stimulation, deep brain stimulation or even neurofeedback,” Bassett said, “but the problem has been that there is little theoretical basis to determine how these stimulations affect the dynamics of the whole brain. In most cases, stimulation is applied via trial and error. This research helps to build up an understanding of the impact of stimulation in one region on cognition as a whole.”Future research will test whether “wiring” differences between people predict their performance on cognitive tasks. It will also underpin work on therapeutic and adaptive technologies that capitalize on brain networks’ unique advantages over their computerized counterparts.
Article: Penn, University of California and Army Research Lab Show How Brain’s Wiring Leads to Cognitive Control
Paper: Controllability of structural brain networks
Huge Flock of Starlings Caught on Film (Hereford, UK 2014)
At 20:40 Katie Witkiewitz begins discussing the use of tDCS as a tool for enhancing mindfulness training. Her work is mostly focused around addiction and recovery. She compares her own experience of using tDCS-assisted meditation to day 4 of a multi-day meditation retreat. They are using the anode F10 / cathode left shoulder (“Where’s Waldo” DARPA research) montage. There’s a shot of what she calls the ‘octa box’ which seems to be distributing current from a single ActivaDose device to 8 sets of electrodes for ‘group mindfulness training’ (but I could be wrong). Could tDCS enhance your meditation? Provide that extra bit of calming the chatter? She goes on to say that (including her own personal experience) the montage ‘inhibits verbal ability’ and that trying to lead a guided meditation while stimulating F-10 gave her ‘the worst headache’.
We met Ana Maiques, the co-founder of Neuroelectrics, maker of StarStim, in our first podcast. It should be pointed out that StarStim is a research-grade tDCS/EEG device that includes a powerful suite of software. In fact it’s not available to the general public.
Spanish research student, Azahara De La Vega Fernandez (pictured with Brian) is investigating under psychology lecturer Nick Davies how brain stimulation can be used to improve sporting ability Photo: Alistair Heap
She invited me to throw ten darts before being brain-hacked, and ten darts after.
And, while the current was gently sizzling through me, she played me a tape in which a man calmly talked me into picturing how brilliantly I was going to throw those arrows.
There is no point undergoing tDCS if you’re not already mentally focused.
Davis compares it with a weightlifter taking steroids. ‘If he takes them without pumping iron, they won’t give him bigger muscles,’ he says.
He also summons the example of Andy Murray going back to his chair between games, and replaying in his mind the shots he has just played, as well as imagining himself walking up to the net as the eventual winner.
It’s called visualisation, and all modern sportsmen and women are encouraged to do it.
Davis thinks that tDCS could help them do it better, sharpening that mental imagery. That’s why he’s experimenting on people like me.
First I needed to put my thinking cap on. This is the StarStim, a rubber hat with electrodes dangling from it.
Made in Barcelona, it costs £7,000.
Read more: http://www.dailymail.co.uk/sciencetech/article-3251517/Can-electric-helmet-boost-brain-power.html
Thync works by pulsing small electrical currents, no more than about 20 milliamps, through nerves on the head. A sticky strip of electrodes attaches to places where nerves run close to the skin above the right eyebrow, behind the ear, and on the back of the neck. A small triangular device connects above the eyebrow, and sends electrical pulses out through the electrode strip. According to Jamie Tyler, Thync’s CSO and other co-founder, the effect of pulsing currents along these nerves is to modulate norepinephrine production in the brainstem at the back of the head. The device has two main modes—called “vibes” in Thync-speak—calm and energy. The difference between these two is that energy increases the release of norepinephrine, increasing alertness, whereas calm decreases it.
How cool is that? Adnan Kurt’s device. You may be able to track him down here, if you read Turkish that is. http://www3.istanbul.edu.tr/itf/fizyoloji/makelab/index.php
I use my own, hand made. @DIYtDCS pic.twitter.com/NDQuUwJQt1
— Adnan Kurt (@AdnannKurt) September 29, 2015
Despite thousands of studies, there remain many mysteries. Most studies involve extremely short experiments with few participants, and they often assess results after just a single session, using very specific tasks. That means results are not generally applicable to real-life situations or to all people. And nobody knows what the consequences might be of frequent use for long periods of time, which is how many people would like to use tDCS.
There is plenty of optimism that tDCS will eventually have real, even transformative applications. But that time does has not come. “At the moment, I don’t know about any protocol or device for which we could really say you could use for gaming or everyday tasks and it would improve performance and there would be no risks with it,” Nitsche says. “My advice would be to be cautious.”
Would you let someone zap your brain? Why ‘electronic brain stimulation’ is trending
Revisiting this post from a few months ago because as I slowly wade through these state-of-the-art brain stimulation presentations from the leading scientists in the field, I’m discovering a lot of new information that is not generally known or being discussed. For example, in this talk ‘BrainSTIM2015 – Physiology and functional effects of tDCS and related techniques’, Michael Nitsche explores why 1mA may be a better dosage choice and also how a second session of tDCS 30 minutes after the first may lead to increased plasticity effects.
Vince Clark has just published video presentations from the recent BrainSTIM conference.
This is a real treasure trove of state-of-the-art tDCS and brain stimulation information.
Presenters: Vince Clark, Giulio Ruffini, Marom Bikson, Peter Bandettini, Michael Nitsche, Katie Witkiewitz, Peter Fox, Luke Torre-Healy, Erika Ross, Mayank Jog, Abbas Babajani-Feremi, Alexander Opitz, Mark Lowe, Hiroyuki Oya, Felipe Salinas, Shalini Narayana, Branislava Curcic-Blake, Franca Tecchio, Yuranny Cabral-Calderin.
https://www.youtube.com/channel/UCJXWh-KAWQdAYXZAMeH4SCg
We previously showed that application of transcranial directcurrent stimulation (tDCS), specifically unipolarcathodal stimulation over the left parietal cortex,results in suppression of the vestibular system.Herein, we assessed whether such suppression of ves-tibular activity using tDCS in normal controls mayalleviate motion sickness.
Press: Highly effective seasickness treatment on the horizon
Paper (Open): Electrocortical therapy for motion sickness
Effect of tDCS Current on Single-Pulse MEP (motor evoked potentials) Amplitudes This figure taken from Batsikadze et al. (2013)) shows that the “classic” inhibitory profile of 1 mA of cathodal DC stimulation is reversed when intensity is increased to 2 mA.
The Effects of tDCS Polarity. One of the features of the literature in tDCS cognitive studies is the implicit assumption that anodal stimulation is always excitatory and cathodal stimulation is always inhibitory (see Horvath et al., 2015a). Bestmann et al. (2015)) have given a detailed account of why this cannot be the case. It is broadly true that polarity-dependent tDCS changes are directional; however, the effects are not uniform under the electrodes (Batsikadze et al., 2013) and interactions with different cell morphologies and cortical surface shapes create inhomogeneities that in turn change the net effects of stimulation (Bestmann et al., 2015). This is one reason to approach the link between assumed physiology and behavioral effects with caution. It is an important message of this Primer that the field needs to stop making naive one-to-one links between polarity and behavior.
Source: Non-invasive Human Brain Stimulation in Cognitive Neuroscience: A Primer: Neuron
[Update 9/3] Because the tweets just keep on tweeting!
Study author Laura Steenbergen:
We performed this study in August/September 2014, which was before the V2 headset or software were available or even announced.
The study states:
In this study, we tested whether the commercial transcranial direct current stimulation (tDCS) headset foc.us improves cognitive performance, as advertised in the media.
In fact, at the time the study took place, using the Focus v1 device, the (June 25, 2014) website stated:
Stronger, faster, quicker
Excite your prefrontal cortex and get the edge in online gaming
A supposedly memory-enhancing commercial brain-stimulation device actually impairs memory: http://t.co/hufIWdksRq pic.twitter.com/UJK1qutOl7
— BPS Research Digest (@ResearchDigest) September 2, 2015
[Update 8/30 Getting a little bit into the weeds here, but having put some time/thought into this r/tDCS thread reply I thought to post it here too to further clarify my issues with the study.]
I’m not sure why you call it ‘the standard foc.us montage’. The v1 montage was a bad choice, they recognized that and moved on. What would you say about the foc.us product as presented on their website now? Fregni’s study isn’t what I’d hope for in a study either. Maybe this ‘Unfocus’ study should have confirmed Fregni’s results using their testing protocol with a ‘medical tDCS apparatus’ before finding that the foc.us v1 device ‘impairs working memory’. In the study, they state:
In this study, we tested whether the commercial transcranial direct current stimulation (tDCS) headset foc.us improves cognitive performance, as advertised in the media.
But in another interview (translated) she states:
Reuning: The company that sells this device, thus claiming that it improves working memory. Is that correct? Steenbergen: Well, at least for the new version of the device they advertise on their website. The version we tested is intended to improve performance in computer games, according to the manufacturer.
Did foc.us ever state that the v1 ‘improved working memory’? I don’t think so. Here’s what I think this whole study is really about (again, translated from the same article):
…Of the medical equipment we know that they are safe. We know which regulations need to be followed if one wants to use them. But for the non-prescription devices there are no such provisions.
And yes, totally agree that all sorts of claims are being made. It’s a challenge to parse out good science, especially now that VC and DARPA money are coming into brain stimulation. Not to mention claims made by manufacturers of devices. But all that keeps it interesting and fun actually.
I would have been completely okay with this just being another bad tDCS study if it wasn’t so blatant a hatchet job on foc.us and the diy community in general.
[Update 8/28]
“Unfocus” on foc.us study – Our Response
For the record – the original foc.us gamer was tested and CE certified by an independent UK based Notified Body to standards EN60601-1:2006 and EN60601-2-10:2000.
It was the first CE certified consumer tDCS device. As far as we are aware, foc.us remains the only CE certified consumer tDCS device available today.We welcome researchers who want to test our claims, especially independent 3rd parties who do it without telling us. But we find ourselves disagreeing with the facts presented and thus conclusions of this report.
Michael Oxley
foc.us co-founder
Source: “Unfocus” on foc.us study – Our Response
[Update 8/19] Noticed that Thync’s Jamie Tyler had this to say…
https://twitter.com/jamiethync/status/633650859767910400
https://twitter.com/jamiethync/status/633654698650808321
[Update 8/20] Have been in touch with study author Laura Steenbergen who cleared up my question about which version of the Foc.us device/software was used in the study:
We performed this study in August/September 2014, which was before the V2 headset or software were available or even announced. Hence, we used the software that belonged with the V1 apparatus (which by then was not even available for android yet ;)). Publication of scientific data is a long process, which is one of the reasons we repeatedly state that these findings only apply to V1 (we have no knowledge about V2). Confusingly, some media websites post a picture of the V2 foc.us with our findings… But that is beyond my control… I hope this clarifies the situation.. Best, Laura Steenbergen
Of course in the context of there only being one Focus device at the time, their use of the term ‘device’ would imply the entire contents of the box they received. There were no v2 headsets at the time they conducted the research. It’s my awareness of subsequent product developments that confused my initial impression. That plus the fact that the media are denigrating Focus for a product that doesn’t exist based on research that happened over a year ago.
Confused about this study… They tested the Foc.us v1 headset with the Foc.us v2 software. Then declare the device “…cannot be regarded as an alternative to CE-certified tDCS devices, the use of which has been demonstrated to be successful in promoting WM.” But the v1 headset has been controversial since Foc.us first released it! And having v2 of the app/software would imply that they made the choice not to use the newer headset (which follows a more common montage protocol). Anyway… it got published, and we’re talking about it and the buzz gremlins put their spin on it and spread it hither and yon.
In the current study, psychologists from the Netherlands worked with 24 healthy participants, attaching tDCS electrodes to their foreheads as recommended for stimulating the cortex. They used a commercial tDCS headset called “foc. us” that offers gamified and non-gamified stimulation and claims it can increase athletic endurance in addition to cognition. Participants visited the laboratory two times and were each given — unbeknownst to them — both a real stimulation session and a placebo-like service.
Source: Widely available brain training device could impair memory: study – Yahoo News
Reddit discussion: https://www.reddit.com/r/tDCS/comments/3hbe3s/impaired_memory_with_focus/
Paper: “Unfocus” on foc.us : commercial tDCS headset impairs working memory
Any other type of sensory stimulation (incl different sham) could have produced same weak effects on WM #junk #tDCS http://nws.mx/1gU30dI
@sciencelaer thx read it yesterday – lights, tones, etc really could have produced same minimal WM differences – so much junk tDCS research
