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Transcranial Direct Current Stimulation (tDCS) is a non-invasive procedure in which a device sends a small Direct Current (DC) across the scalp to modulate brain function. Conventional tDCS devices will consist of a positive anode and negative cathode. When the low level current enters through the anode, the stimulation causes an excitation in neuronal activity. Conversely, when the current exits through the cathode, the stimulation causes a reduction in neuronal activity. Knowing this, anodal and cathodal stimulation, can be used in various applications to alter the neural activity of the brain. Since anodal stimulation causes an excitation in neuronal activity, it can be used to potentially enhance the area of the brain being targeted. Alternatively, as cathodal stimulation causes an inhibition of neuronal activity, it can be used to potentially decrease activity in the brain resulting from the hyper-activity associated with certain psychological disorders.
Most people who want to use tDCS for research, treatment or performance enhancement want to reproduce a tDCS protocol that has been studied and published in a scientific paper. These include several popular approaches such as bi-frontal stimulation (for mood and attention), motor stimulation (for motor learning and pain control) and the so-called DARPA montage (for learning and vigilance). Though there are many variations in “dosage” used (how much current, time, number of sessions), the idea is always reproducibility; reproducing what was done before not only from the perspective of efficacy (outcomes) but also tolerability (safety, how things feel). The right device, along with the correct electrodes and headgear, , are critical for reproducibility. It is a mistake to assume that any device that provides stimulation is acceptable. With this in mind, Caputron has created the table below help guide you through the important features on the select devices we carry to provide you the best options for reproducibility and value. Caputron kits are designed to make sure you get a complete system designed to work together. You can also see our electrode guide for what is important regarding electrodes.
Choosing the best tDCS device can be tricky. As tDCS continues to grow in popularity, more and more devices are being made available to consumers. One of the most frequently asked questions we get at Caputron is what tDCS device do we recommend. View our blog post on the best selling tDCS devices of 2018.
All research grade systems have timers, automatic ramp up/down, continuous impedenance monitoring, low battery indicator and are IEC 60601 safety and EMC compliant.
Disclaimer: The information provided here is not medical or legal advice. It is not an endorsement of any device, application or use. It is based entirely on information in the listed publications and information from manufacturer websites.
What is consumer tDCS? Consumer tDCS devices are marketed directly towards users. They can be marketed simply as “tDCS” or for cognitive enhancement or for performance enhancement. They cannot be marketed for medical use, such as the treatment of a disease, since then they would be classified as medical devices. Once a consumer obtains a tDCS device, they can use their device for for any application. Consumer devices are cheaper then medical / research grade devices. The FDA has provided letters to companies like Thync and Halo; allowing them to market tDCS for consumer purposes without making claims on medical therapy.
What are the standards for Consumer tDCS? The quality of consumer tDCS devices varies. At the high end, devices such as Halo, Thync and ActivaDose are produced to the same standards as medical devices, they are just not cleared by the government for medical use and are not marketed by the companies for medical use. These products likely meet the “LOTES” guidelines. On the other extreme, there may be products that are not carefully designed or built. Poor design can mean things like not producing the correct output. Poor build simply means that products may be sent out with defects.
What is research grade tDCS? Research tDCS devices are those marketed for use in clinical trials. Research devices used in clinical trials must see the same design and manufacturing standards as clinical tDCS devices. This means, according to regulations in the US, Europe and other countries, devices tested on people need to be built to medical devices standards, even when they are not yet approved for use. For this reason, clinical and research grade tDCS devices are the same thing as far the devices themselves. The difference is simply how they are marketed. For example, the Soterix Medical 1x1 tDCS is marketed in the US for research but is approved and marketed in Europe for the treatment of depression, pain (migraine, fibromyalgia) and stroke rehabilitation.
What are the standards for Research and Medical grade tDCS? The standards that govern research and medical grade tDCS in the US are called FDA Quality Systems which rely on the rules by the IEEE organization. The comparable standards in Europe are part of the CE mark and relies on rules set by the IEC organization. But since the IEEE and IEC are almost identical, medical / research grade tDCS products usually meet standards across the US, Europe and other countries.
What is the difference in cost? Consumer devices range from about $80 to $500. Medical and research devices range from $300 to about $5,000 for top brand to over $10,000 for the more advanced High-Definition systems.
What about iontophoresis devices? An iontophoresis devices is cleared by the FDA or another country for the use of direct current stimulation to deliver ions or drugs to the body. When used without drugs, the delivery of ions is for all practical purposes the same thing as tDCS. The use of an iontophoresis device for tDCS treatment would be “off-label”.
What is HD-tDCS? HD-tDCS stands for High Definition transcranial Direct Current Stimulation. Regular tDCS uses relatively large electrodes (about 5x5 cm) while HD-tDCS uses relatively small electrodes (about 1x1 cm) which are gel filled. HD-tDCS is found only on Research / Clinical grade devices. HD-tDCS can be used with EEG to record brain activity.
Can the same device be a consumer and medical / research grade tDCS device? This can be complicated, but yes. The Thync device and the Fisher Wallace devices, neither of which are basic tDCS, have separate websites for consumer and medical use, but it's the identical device. Medical and research tDCS devices cannot be sold to consumers, though they can be provided via a medical care-giver. Bottom line, the devices listed below as Consumer can be bought by anyone, whereas the ones listed under Medical / Research, can only be bought by medical care-givers or researchers.
Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. Bikson M, Paneri B, Mourdoukoutas A, Esmaeilpour Z, Badran BW, Azzam R, Adair D, Datta A, Fang XH, Wingeier B, Chao D, Alonso-Alonso M, Lee K, Knotkova H, Woods AJ, Hagedorn D, Jeffery D, Giordano J, Tyler WJ. Brain Stimul. 2018 Jan - Feb;11(1):134-157. doi: 10.1016/j.brs.2017.10.012. Epub 2017 Oct 17.
A pragmatic analysis of the regulation of consumer transcranial direct current stimulation(TDCS) devices in the United States. Wexler A. J Law Biosci. 2015 Oct 12;2(3):669-696. eCollection 2015 Nov. PMID: 27774217
The off-label use, utility and potential value of tDCS in the clinical care of particular neuropsychiatric conditions. Bikson M, Paneri B, Giordano J. J Law Biosci. 2016 Sep 10;3(3):642-646. doi: 10.1093/jlb/lsw044. eCollection 2016 Dec. No abstract available. PMID: 28852542
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal A, Alekseichuk I, Bikson M, Brockmöller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Flöel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19. Review. PMID: 28709880
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Brain Stimul. 2016 Sep-Oct;9(5):641-61. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15. Review. PMID: 27372845
Outstanding questions concerning the regulation of cognitive enhancement devices. De Ridder D, Vanneste S, Focquaert F. J Law Biosci. 2014 Sep 19;1(3):316-321. eCollection 2014 Sep. PMID: 27774170
Early adopters of the magical thinking cap: a study on do-it-yourself (DIY) transcranial direct current stimulation (tDCS) user community. Jwa A. J Law Biosci. 2015 Jun 2;2(2):292-335. eCollection 2015 Jul. PMID: 2777419
A technical guide to tDCS, and related non-invasive brain stimulation tools. Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22. Review. PMID: 26652115
Noninvasive techniques for probing neurocircuitry and treating illness: vagus nerve stimulation(VNS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation(tDCS). George MS, Aston-Jones G. Neuropsychopharmacology. 2010 Jan;35(1):301-16. doi: 10.1038/npp.2009.87. Review. PMID: 19693003
Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. PMID: 25983531
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