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http://www.york-services.com/simple-joy-6/
http://brmlab.cz/project/brain_hacking/tdcs
The story of Transcranial direct current
stimulation (tDCS)
Potential
cure
Cognitive
enhancement
Big Brother’s
diabolical mind
controlling
machine
The policy problem - Regulation
Medical device :: Drug
Cognitive enhancement device :: Vitamin
Policy Recommendation
● Regulate tDCS like medically approved forms of brain
stimulation (rTMS or CES) until we have longitudinal data
● “CEDs are similar to devices already covered by
legislation for medical devices. They intervene to
modify physiological processes, and present varying
degrees of physiological risks and potential sideeffects...no relevant distinction exists between devices
used for treatment and enhancement in terms of
mechanism” (Maslen et al., 2013)
Sources:
● http://www.slate.com/articles/technology/superman/2013/04/tdcs_and_rtms_is_brain_stimulation_safe_an
d_effective.html
● http://www.hopkinsmedicine.org/psychiatry/specialty_areas/brain_stimulation/tdcs.html
● http://theweek.com/article/index/226196/
● http://neuroethicscanada.wordpress.com/2012/03/06/tdcs-does-not-reduce-the-authenticityobjection/#more-2007
● http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61931-5/fulltext
● http://www.theguardian.com/science/head-quarters/2013/oct/07/neuroscience-psychology?CMP=twt_gu
● http://www.technologyreview.com/news/410389/want-to-enhance-your-brain-power/page/2/
● Fitz, N., Reiner, P.B. The challenge of crafting policy for do-it-yourself brain stimulation (June 3, 2013) J
Med Ethics dio: 10.1136/medethics-2013-101458
● U.S. Food and Drug Administration. ‘Petitions to request change in classification for cranial electrotherapy
stimulators’ (FDA executive summary, prepared for the February 10, 2012 meeting of the Neurologic
Devices Panel, 2012.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/Medical
DevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM290787.pdf
● Costello, A.H. Guidance for Industry and Food and Drug Administration: Class II Special Controls
Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems (2011)
● Pea, C., Kristen Bowsher, Ann Costello, Robert De Luca, Sara Doll, Khan Li, Marie Schroeder, and
Theodore Stevens. "An overview of FDA medical device regulation as it relates to deep brain stimulation
devices." Neural Systems and Rehabilitation Engineering, IEEE Transactions on 15, no. 3 (2007): 421424.