Regulating consumer use of transcranial direct current stimulation devices

Anne-Maree Farrell, Adrian Carter, Nigel C Rogasch and Paul B Fitzgerald
Med J Aust 2018; 209 (1): . || doi: 10.5694/mja17.00778
Published online: 2 July 2018

Uncertainty about the safety of unsupervised use of technologies to enhance cognition, mood and behaviour warrants regulatory oversight

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation device that uses a small electrical current (∼ 1–2 mA) between two or more electrodes placed on a person’s scalp to manipulate neural activity. The current is not enough to cause brain cells to fire, but can change their readiness to fire, potentially influencing learning and cognition. There is considerable evidence that tDCS can modulate cortical excitability for brief periods (∼ 30 min) after a single 20-minute application.1

  • 1 Centre for Health Law and Society, La Trobe University, Melbourne, VIC
  • 2 Monash Institute of Cognitive and Clinical Neurosciences, Monash University, Melbourne, VIC
  • 3 Monash Alfred Psychiatry Research Centre, Alfred Health, Melbourne, VIC
  • 4 Epworth HealthCare, Melbourne, VIC



Anne-Maree Farrell is supported by an Australian Research Council Future Fellowship (FT130101768). Adrian Carter is supported by a National Health and Medical Research Council (NHMRC) Career Development Fellowship (identification no. APP1123311). Nigel Rogasch is supported by an NHMRC Early Career Fellowship (no. 1072057).

Competing interests:

No relevant disclosures.

  • 1. Hill AT, Rogasch NC, Fitzgerald PB, Hoy KE. Effects of prefrontal bipolar and high-definition transcranial direct current stimulation on cortical reactivity and working memory in healthy adults. Neuroimage 2017; 152: 142-157.
  • 2. Brunoni AR, Moffa AH, Sampaio-Junior B, et al. Trial of electrical direct-current therapy versus escitalopram for depression. N Engl J Med 2017; 376: 2523-2533.
  • 3. Hill AT, Fitzgerald PB, Hoy KE. Effects of anodal transcranial direct current stimulation on working memory: a systematic review and meta-analysis of findings from healthy and neuropsychiatric populations. Brain Stimul 2016; 9: 197-208.
  • 4. Wexler A. The social context of “do-it-yourself” brain stimulation: neurohackers, biohackers, and lifehackers. Front Hum Neurosci 2017; 11: 224.
  • 5. Wexler A. Who uses direct-to-consumer brain stimulation products, and why? A study of home users of tDCS devices. J Cogn Enhanc 2018; 2: 1-21.
  • 6. Jwa A. Early adopters of the magical thinking cap: a study on do-it-yourself (DIY) transcranial direct current stimulation (tDCS) user community. J Law Biosci 2015; 2: 292-335.
  • 7. Maslen H, Douglas T, Cohen Kadosh R, et al. The regulation of cognitive enhancement devices: extending the medical model. J Law Biosci 2014; 1: 68-93.
  • 8. Bikson M, Grossman P, Thomas C, et al. Safety of transcranial direct current stimulation: evidence based update 2016. Brain Stimul 2016; 9: 641-661.
  • 9. Brunoni AR, Amadera J, Berbel B, et al. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol 2011; 14: 1133-1145.
  • 10. Rikkers W, Lawrence D, Hafekost J, Zubrick SR. Internet use and electronic gaming by children and adolescents with emotional and behavioural problems in Australia — results from the second Child and Adolescent Survey of Mental Health and Wellbeing. BMC Public Health 2016; 16: 399.
  • 11. Davis NJ. Transcranial stimulation of the developing brain: a plea for extreme caution. Front Hum Neurosci 2014; 8: 600.
  • 12. Riggall K, Forlini C, Carter A, et al. Researchers’ perspectives on scientific and ethical issues with transcranial direct current stimulation: an international survey. Sci Rep 2015; 5: 10618.
  • 13. Therapeutic Goods Administration. Australian regulatory guidelines for medical devices (ARGMD) (under review): part 1 — introduction. Commonwealth of Australia; 2011. (viewed July 2017).
  • 14. US Food and Drug Administration. Public workshop: neurodiagnostics and non-invasive brain stimulation medical devices workshop. Silver Spring, MD (USA); 19-20 Nov 2015. (viewed July 2017).
  • 15. US Food and Drug Administration. General wellness: policy for low risk devices. Guidance for industry and Food and Drug Administration staff. Rockville, MD: FDA; 2016. (viewed July 2017).
  • 16. European Commission. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Art 2(1), OJ L 117/1. Official Journal European Union 2017; 60: 1-175. (viewed Apr 2018).


remove_circle_outline Delete Author
add_circle_outline Add Author

Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Online responses are no longer available. Please refer to our instructions for authors page for more information.