#brain stimulator

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I’ve been intrigued by the Thync device ever since I heard one of its scientific leaders (William Tyler) speak at a conference on brain stimulation, but between its rather expensive price point and a lack of Android compatibility I’d had a lot of trouble getting my hands on one--until John Humphrey at DIY tDCS sent me a unit to try out! Over the last few weeks I’ve been putting the thing through its paces and found some interesting things about how (and how effectively) it works.

How does it work?

The Thync device actually consists of two parts--the Thync module and an adhesive ‘strip” that both passes current through your head and physically holds the module on. The device is attached at two points--the module sits over your left forehead, while the other end of the strip attaches to either the back of your neck (for the “calm” mode) or behind your ear (for the “energy” mode). These two connections complete a circuit that allows the device to send its “vibes” through your head.

Thync headset in the “energy” configuration

An interesting consequence of this design is that Thync is very spatially non-focal. Although the company claims to target specific nerves, there is probably quite a lot of “off target” current interacting with various other systems, including current passing through the brain directly. All this means that, it’s wise to take Thync’s claims about how their device works by stimulating specific nerves with a grain of salt. The actual current that the device is sending through the head is a current-regulated set of rapid pulses. It’s a high frequency alternating current signal that is in many ways similar to the one generated by a TENS device used to treat pain (although the pulse frequency of the Thync device is much higher, typically somewhere between 1 and 10 kilohertz depending on the “vibe” being used.)

The other difference between the Thync and other nerve stimulators is that the “vibe” signals are extremely complex. While most nerve stimulators use a single, repeating pattern the Thync vibes are not only all different from each other but also vary continuously throughout each session.

One way to deal with this complexity and figure out how the vibes actually work is to figure out what’s different between vibes with supposedly opposite effects--the “awake” and “sleep” vibes, for instance. One difference here is anatomical--the vibes that are supposed to make you calm, like the sleep vibe, use an electrode placed over the back of the neck, while the “energy” vibes place the electrode behind the ear. There’s also an interesting difference in the signals the device uses though:  the calm vibes seem to be significantly “burstier” (their power varies more at high frequencies) than the energy vibes. This property is interesting in light of Thync’s (largely hypotheticall) interpretation of how how input to sensory nerves might affect arousal level, which focuses on how these inputs might cause norepinephrine-containing neurons in the locus ceruleus to switch between constantly-firing states (associated with high arousal and energy) and intermittent firing (associated with lower arousal). It’s therefore possible that the “bursty” input from the Calm vibes is designed to encourage intermittent firing, while the more constant input from Energy vibes is intended to increase constant firing. (Keep in mind that while I think this is plausible, it’s just my interpretation and not necessarily correct)

Bursty signal (top) vs continuous signal (bottom)

Vibes also have a number of other interesting parameters however. The power and rate of nerve-stimulating pulses delivered by the vibe fluctuates throughout the session (these changes are slow enough that I suspect that they’re related mostly to comfort and reducing habituation rather than having a direct functional role) and different vibes use differently shaped waveforms, something that might be useful in tuning stimulation to affect specific subpopulations of nerve fibers (you could even, theoretically, use this property to make the Thync only activate the nerve fibers under one of the electrodes and leave the ones under the other electrode alone).

These vibes also have another property--they  sometimes include what is essentially tDCS, or more specifically an AC waveform superimposed on a constant DC current. Unlike most nerve stimulators (where the flow of current one direction through the circuit is balanced by flow the other way), the Thync device uses unbalanced waveforms where the total current flowing one way is higher than the total current flowing the other--creating a DC current which can be quite strong (up to 5 milliamps at the device’s maximum power!)

An example Thync waveform with a DC offset. The positive current (arbitary units) is greater than the negative component, creating a net flow of charge.

Oddly, the tDCS doesn’t seem to have a clear functional role. In all cases, the forehead-mounted part of the device acts as the anode of the circuit--something that would make sense if, for instance, Thync was trying to replicate this protocol which showed caffeine-like effects from frontal stimulation . But the device delivers the same kind of tDCS when you turn on the “sleep” vibe, a somewhat strange design decision if the tDCS was what was supposed to keep you awake. Instead, I suspect that the use of tDCS is sort of incidental--the device uses a waveform that is optimized for something else, and just happens to have a net flow of charge.

The takeaway

One of the big takeaways here should be that the Thync’s mechanism of action is very broad. In addition to acting on the targeted cranial nerves, the fact that current is allowed to diffuse through the head means that it is potentially acting on a number of other mechanism, such as direct current stimulating and high frequency alternating current stimulation/random noise stimulation acting directly on the brain. That is not bad per se--lots of interventions,particularly those targeted at the brain, have complex and poorly understood mechanisms of action. But the complexity of Thync’s mechanism of action also leaves a lot of unanswered questions--could it produce subtle cognitive deficits, as some forms of tDCS seem to do? Does it affect inflammatory processes in the brain?  Can it alter brain plasticity? Answers to these questions seem to be critical for informed use of the device.

But does it work?

All these potential mechanisms of action are, of course, contingent on the assertion that the Thync device actually does what it says it does--makes you calmer or more energetic, depending on which vibe you’re using. So for that, it’s worth taking a look at the evidence behind the device. The idea that pulsed electric current can influence energy and mood is actually not a new concept--its modern form, which bears some interesting similarities with the techniques used by the Thync device, was first developed by European and Soviet scientists as a way to reduce the need for chemical anesthesia during medical procedures. This technology was later adapted to forms known as “electrosleep” and “cranial electrotherapy stimulation”, which found some success in treating arousal disorders like anxiety and insomnia. More recently, sedative effects have been reported from the Cefaly nerve stimulator,  an experiment that is interesting in that it is one of the only cases where the sedation could be attributed to stimulation of a particular nerve (in this case the trigeminal).

Early "electrotherapy” protocol, somewhat reminiscent of what the Thync does.

Source:https://www.alleviahealth.com/wp-content/uploads/2014/06/Zaghi-et-al.-2009.pdf This means that the claim that the Thync device can induce calmness or help sleep is quite plausible. However, because of the variations in protocols used by these devices, it’s important to look at efficacy of the Thync device specifically, something that Thync did in two blinded studies.

The first of these studies , looking at the immediate subjective and physiological effect of Thync’s calm vibes,  found a number of changes indicating that it decreased physiological arousal. Most importantly for users, the researchers reported that the Thync reduced reported anxiety on the Profile of Mood States. The second study found that using Calm vibes before bed resulted in a significant increase in sleep quality, as well as an improvement of several other aspects of mental health likely due to the better sleep.

While these results suggest that the Thync calm vibes can reduce physiological arousal, for a consumer device it’s important to take into account the practical significance of an effect, not just the statistical significance.  The reduction in stress seen on the POMS, while statistically better than the placebo, is still quite modest--a reduction of 0.37 points on a 36 point scale. In practical terms that’s a very small effect--for instance it’s slightly smaller than the baseline difference between relaxed men and relaxed women. 

While the effects on sleep quality are more dramatic (including an increase of about 20 minutes in the nightly  time asleep that likely drove several other improvements in mental health )  I’m not convinced that using the Calm vibes for an immediate effect (the way they’re advertised) would produce any real noticeable effect. As for the Energy or Fitness vibes, Thync has produced no research no them whatsoever.

Impressions

There are a lot of things about Thync that made me go “wow”--the technology, the vision of affective and cognitive enhancement through electrical signalling, and the prospects for what technology like this could tell us about how the brain works.

What didn’t particularly wow me was Thync as a consumer product.  While it definitely has a sci-fi coolness to it, there’s a question here that’s important to address: Is the Thync more effective in any way than breathing exercises, listening to music, taking a walk, meditation, or any of the dozens of other methods for modulating arousal that don’t require sticking a $200 machine to your face? Given the modest effects of the calm vibes and the unknown effectiveness of the energy vibes, I’m not sure it is.

Another aspect of the “is it worth it” calculation is risk, and I think this is one of the biggest ways that Thync’s entry as a consumer device is premature. There is of yet no universally-accepted standard for showing that a device like this is safe--for instance,should there be screening just for obvious problems like skin burns, or also for more subtle ones like depressive symptoms?--and our incomplete understanding of how the Thync actually affects the brain makes it even harder to tell what adverse effects we should look for. That’s not to say that the Thync device is dangerous (so far there have been no reports of serious adverse effects), but the lack of good safety standards and a solid mechanism of action means that adverse effects we simply haven’t detected yet are a very real possibility.

None of these are intractable problems of course. Thync could always do more research, or publish research that they’ve already done, and they have an opportunity to play a major role in the project of figuring out how we should think about the safety and effectiveness requirements for these devices. But for now, the Thync device reminds me a lot of what Dr. Tyler said about neurostimulation technology at NYC neuromodulation--that much of it was a “neat lab trick looking for a way out”. So far, I don’t think they’ve found it.

Other observations

In addition to its nerve-stimulating effects, the Thync app makes heavy use of psychological suggestion. Notice the number of times that the voiceover says something like “when I use this vibe, I feel <x>”--this is a classic technique that’s used (by hypnotists, for example) to actually induce specific sensations. That’s not to say that the Thync relies entirely on this kind of suggestion ( the placebo-controlled studies show that there is some effect directly attributable to stimulation), but the suggestion might be just as powerful (or even more so) than the effects of the stimulation.

Thync has two “generations” of Calm vibes: the first uses higher frequency stimulation, while the newer generation uses a lower frequency. This is likely due to research showing that the low frequency stimulation was more effective.

Unlike, say, tDCS, you’re supposed to be able to feel a sensation from Thync--in the target range it feels like tingling, and if the power is turned up too high you get a dull burning sensation. One implication of this is that placebo stimulation can feel different from real stimulation and studies need to be very careful to make sure their blinding is actually effective.

It’s entirely possible to use the Thync with custom or third-party electrodes so long as they can snap into the two snap connectors on the bottom of the Thync module. The Thync won’t detect it as a calm or energy strip, but you can use any vibe with the custom electrodes.

The actual effect of the Thync vibes on POMS scores is surprisingly small compared to the glowing anecdotal reviews that people give of them. This is mostly likely because people are reporting placebo effects, but it could also be related to flaws in the experimental design. One interesting thing is that  the subjects who got a placebo were also quite relaxed, suggesting that they might have been at their individual “floor” of anxiety before the treatment or that the placebo might have actually had some active effect.

Recordings

To download recordings of the Thync vibes,click here

I’ve made recordings of the complete Thync vibes for anyone who’s interested in taking a look at them. Because of the frequencies that the Thync device operates at, audio recording and analysis software is well suited to recording and analyzing the vibes; in this case I used an external USB microphone input to capture the voltage drop across a resistor. The values in this file represent the current output by the Thync device at 2% power. Due to the limitations of the audio card, high-amplitude vibes had to be recorded with a different resistor than low-amplitude vibes--this means that for files prefaced with “100” the scale is -4.35 mA to 4.35 mA, while for files prefaced with “33” it is -13.18 ma to 13.18 mA. For files prefaced with “473” the scale is -0.92 mA to 0.92 mA.  In all these recordings, the Thync output closest to its USB port is connected to the “terminal” input of the microphone TRS connector, the other output is connected to the sleeve.

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About a month ago I got an offer from John (who runs DIYtDCS and Michael Oxley (who runs foc.us)  to review foc.us's new device (the V2). Since I was curious about how exactly this thing works, I accepted, and promptly received a new V2 which sat on my table for about a month while I wrote a paper. Which is submitted now! So anyway...

The foc.us V2 “controller” module

Overall

The box I received contained the foc.us controller/current source, a dock for connecting it to a computer, the “Gamer” headset, a bunch of sponges, and an incredibly ugly shirt.

Shirt aside, the first thing you notice about the foc.us is that it's slick. When you work around laboratory and DIY versions of this technology for years, there's something about picking this thing up that makes it feel like it's from the future.

The V2 is a modular system, which means that the actual device that generates the current is a small black rectangle, about the size of a particularly chubby flash drive. It has a connector on one end, which is where you plug in electrodes, and an internal Bluetooth chip for communicating with a smartphone or computer.. You control it using and integrated screen and a directional knob, which is surprisingly intuitive. The screen also shows you real-time information during a stimulation session.

Speaking of Bluetooth, it's also important to point out that if you buy a foc.us now, you’re buying the “developer edition”, which means it’s actually not done. While the hardware and basic stimulation functions are all functional, some features in the software are not quite implemented yet. While these are generally not huge issues; some of the features that are advertised don’t yet exist in the device; for instance the device supposedly has a “double-blind mode” which lets you use sham stimulation on yourself; it applies the sham but there’s no way to look back at which sessions were sham and which were real stimulation.

Overall, the build quality of the device is…variable. While the stimulator unit seemed solidly put together, the Gamer headset broke a couple minutes after I took it out of the box. The issue here is that the Gamer headset electrodes are attached to an aluminum frame by a fairly flimsy plastic connector which breaks if it’s twisted (something that’s likely to happen when adjusting the electrodes).

 Safety

This was perhaps the biggest question I had about new new foc.us device, given the company’s history of safety issues in the past. Luckily, this seems to be one of the areas where they’ve dramatically improved; none of the previous safety issues persisted and at all times the device’s output never exceeded its specifications or a safe envelope.(see footnote)

The most visible change here is the electrodes. Both the Gamer headset and the new Edge headset now use white sponge electrodes which measure 9 and 12.25 square centimeters in area depending on the type. While the current density delivered by these electrodes operating at the maximum 2 mA output is within the range often used in research, it’s also rather high compared to many other tDCS devices. Therefore, it’s prudent to carefully monitor for skin damage when using this device, particularly at higher current intensities.

The foc.us also includes some new safety features designed to reduce the risk of high-current-density induced injuries. The most interesting is a soft voltage limit; while the device can technically output voltages out to 60V, users can specify a lower limit to not exceed. This provides protection if the connection between electrodes and the head starts to fail (due to electrode drying or drift, for instance); rather than increase voltage to the absolute maximum in an attempt to drive the target current over the failing connection (which can result in very high current density through a small patch of skin), the device can be configured to simply allow the current to drop using this limit. Unfortunately, there’s no actual alert that the connection is failing (although this can be deduced from looking at the current monitor during operation) but this still provides a good way to avoid many of the safety issues that the high maximum operating voltage would otherwise entail.

Another important area of safety is the ability of the current regulator to maintain its specified current and voltage outputs under varying conditions.  Here I tested the device under two conditions: with relatively stable impedance at varying levels (simulating a typical use case in a person sitting still) and in an “impulse” condition, where impedance changes instantly from very high to very low or vice versa. The purpose of this testing method is to measure the device’s response to temporary very sharp changes in impedance caused by disconnection and reconnection of the electrodes as might occur in the Edge device when used during athletic performance.

Here the foc.us performed perfectly; neither current nor voltage ever significantly exceeded their specified maximums under varying conditions. The response to impulses was particularly impressive, with no significant “overshoot” even at the maximum voltage output.

Current trace for from testing. When subjected to a sharp drop in impedance, current returns immediatley to the design level, with no evidence of a “spike” or overshoot.

Stimulation

One of the most interesting things about the new foc.us is the stimulation modes that it provides; in addition to tDCS, it includes options for tRNS (random noise stimulation),  tACS (alternating current stimulation), and tPCS (pulsed current stimulation)

tDCS is your standard anode/cathode tDCS stimulation. On the Gamer headset, this translates to the anode on the left side of the forehead and the cathode on the right. I’m not sure which side is the anode and cathode on the Edge headset (since I didn’t receive one), but the arm electrode is likely to be set as the cathode.

The remaining modes are pretty faithful replications of how these techniques have been used in research. One neat thing is the degree of control the device gives you; you can specify things like whether the oscillation should be bipolar or unipolar (whether the anode and cathode switch) and set DC offsets. I was pleasantly surprised by the degree of control that was offered for the random noise and pulsed current modes; in addition to the previously mentioned controls (offset, max voltage, etc. the device provided really fine-grained control over details like the frequency limits for random noise stimulation and the pulse width for pulsed current stimulation.)

(“What is pulsed current stimulation anywyay?” you might ask? It turns out it’s basically a square wave applied with a specified frequency and duty cycle. There’s not much research into its effects on the brain (although the research there is suggests it’s similar to tDCS), but I suspect foc.us decided to include it just because they could).

From top to bottom: tACS, tPCS, and tRNS current waveforms.

Another interesting feature that can be applied to all the stimulation modes is a sham condition. Here, the current gets ramped down after a configurable delay. There are, in theory, two blinding modes: a “single-blind” mode, where the sham is manually selected and real operating status is displayed on the screen, and a “double=blind mode”, where the device will automatically select whether the a session will be a sham or real session. In this mode, simulated data is displayed on the screen during sham sessions, making it suitable for blinding yourself, although the limitations of the developer edition mean that this mode still lacks logging to tell you whether the session was real or sham.

Strangely, one thing that's missing is the ability to control which electrode is set as the anode and which as the cathode. When using one of the headsets, both electrodes are hardwired to a single connector, and there's no way to change this setting from the software—a strange limitation for a device that otherwise allows a great deal of control over stimulation.

This configurability, incidentally, seems both good and bad. On one hand, the device is insanely capable compared to other commercial devices marketed to DIY users. On the other hand, there's very little instruction provided in the manual or packing about how these modes should be used, and one thing that seems to get lost in foc.us's manual is that the effect of, say, 10-Hz tACS on the brain is quite different from that of tDCS, and that some of the stimulation methods (like tPCS) are quite new and don't have the “track record” of regular tDCS in their safety and efficacy. These methods are nice to have, in other words, but make sure you do your homework before using them.

The science or...not Of course, there's one major issue with an otherwise nicely-designed device, which is that no one knows what it does to your brain.

That's not to say that the company doesn't claim to though.  The webpage for the Gamer headset says that it will “increase your working memory and focus”, which is presumably based on some of the studies showing that stimulation of the dorsolateral prefrontal cortex improves aspects of working memory. There are two issues here, however: first, more recent studies have challenged the idea that stimulating the left prefrontal cortex has any reliable effect on working memory to begin with (In fact, the majority of studies on stimulation of this area have shown no effect), and second, the Gamer headset does not match any of the protocols used to study working memory (its electrodes are located too low on the head).

Electrodes to stimulate the DLPFC (and increase working memory) are generally placed over F3, while the foc.us electrodes naturally sit much lower on the forehead. They can be pushed up slightly, but don’t remain in reliable contact with the head.

So what does stimulating this region do? Unfortunately, very few studies have been conducted on the effects of the gamer headset's “double supraorbital” placement (although the evidence there is suggests it might make you better at lying) due to a historical trend of considering the supraorbital area to be a sort of “neutral site” where electrodes have little effect on the brain. While this assumption is probably not true, the effects of stimulating this area remain poorly defined.

What about the Edge headset? While I didn't receive one to test, there are a few things about it that make me go “hmm”. It's marketed “for exercise” and appears to use an electrode placed vaguely near the left motor/premotor/temporal areas, which is actually not a bad idea if you want to increase endurance. 

What is a bad idea is where the second electrode is placed—on the same side as the first one! While there's no doubt many practical advantages to avoiding the awkward wire-across-the-body design that would be required to place the reference electrode contralateral to the active one, the cost is the loss of any relationship to the studies that showed this type of stimulation was effective in the first place. The effects of brain stimulation are crucially dependent on not only where the active electrode is placed but the path current takes between the active and return electrode. This observation is particularly problematic in the case of the Edge headset, where one potential current path, where current flows through the skull, into the brain, and back to the return electrode, likely has much higher resistance than an alternate current path where electricity flows directly through the subcutaneous tissue between the electrodes, avoiding the brain entirely. The ability of the headset to even deliver a physiologically relevant amount of current to the brain is therefore quite questionable (while the amount of current that gets though could theoretically be quantified by FEM modeling, using this type of modeling with extracephalic placements is beyond the capabilities of any modeling software I know of)

Conclusions

Perhaps the biggest thing that really stood out to me about the new foc.us device is the degree of innovation that it represents for the DIY tDCS community.  It's hard not to come to the conclusion that the V2 is the best commercially available tDCS regulator right now, and that the capabilities it provides (such as double-blinding) will probably open up all sorts of opportunities in the DIY tDCS space), as well as push other device manufacturers to innovate. It's also encouraging to see that the safety and quality control issues that plagued the previous version have been fixed.

At the same time, between the hardware issues and sketchy science, I was underwhelmed by both of the headsets foc.us currently offers. It's clear what the goal here is – to be really successful, consumer brain stimulation devices will need to branch out from their current niche as low-cost versions of the devices used in research and start to offer specific, pre-programmed modes that accomplish specific goals. But there are good ways and bad ways to do this.  The startup Thync, for example, has been conducting extensive in house research on the safety and effectiveness of their device before it's released. Should foc.us do the same, or alternately pivot to making “research type” devices without specific claims  (something they may be interested in, given that they have recently released an adapter for Amrex electrodes), they will have a really great, end-to-end solution for brain stimulation. At present the device is a cable and potentially game-changing DIY brain stimulator—but only if it's not used how it's marketed.

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Brain Stimulator Review VIDEO