The story of Transcranial direct current stimulation (tDCS) Big Brother’s diabolical mind controlling machine Cognitive enhancement Potential cure
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 side-effects...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_and_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-authenticity-objection/#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/MedicalDevicesAdvisoryCommittee/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): 421-424.