1
Giovanni Aldini (1762–1834), Italian physicist, was a nephew of Luigi Galvani, whose treaties on muscular
electricity he edited with notes in 1791. His scientific work was chiefly concerned with galvanism, anatomy and its
medical applications.
(^2) The NuTone 101 was on the market before the FDA acquired authority over devices in 1976.
(^3) https://www.federalregister.gov/articles/2016/01/22/2016-01173/neurological-devices-reclassification-of-cranial-
electrotherapy-stimulator-intended-to-treat#h- 19
(^4) Brown et al. at 329.
(^5) Mischoulon, D., De Jong, M.F., Vitolo, O.V., Cusin,C., Dording, C.M., Yeung, A.S., Durham, K., Parkin, S.R., Fava, M.
& Dougherty, D.D., “Efficacy and Safety of a Form of Cranial Electrical Stimulation (CES) as an Add-on Intervention
for Treatment-resistant Major Depressive Disorder: A Three Week Double Blind Pilot Study,” Journal of Psychiatric
Research 2015 Nov;70:98-105. doi: 10.1016/j.jpsychires.2015.08.016. Epub 2015 Aug 29 (2015). For a thorough
description of CES and a comparison with other forms of brain stimulation, see Kavirajan, H.C., Lueck, K. & Chuang,
K., “Alternating Current Cranial Electrotherapy Stimulation (CES) for Depression (Review),” The Cochrane Library
2014, Issue 7.]
(^6) Shiozawa, P., Fregni, F., Benseñor, I.M., Lotufo, P.A., Berlim, M.T., Jeff Z. Daskalakis, J.Z., Quirino Cordeiro, Q. &
Brunoni, A.R., “Transcranial Direct Current Stimulation for Major Depression: An Updated Systematic Review and
Meta-Analysis,” International Journal of Neuropsychopharmacology 17:1443–1452 (2014).
doi:10.1017/S1461145714000418
(^7) Id. at 198, citing Hutchinson, D.O., Frith, R.W., Shaw, N.A., Judson, J.A.& Cant, B.R., “A Comparison Between
Electroencephalography and Somatosensory Evoked Potentials for Outcome Predictions Following Severe Head
Injury’” Electroencephalography and Clinical Neurophysiology 78(3):228-233(1991) and Southworth, S., “A Study of
the Effects of Cranial Electrical Stimulation on Attention and Concentration,” Integrative Physiological and
Behavioral Science 34(1):43-53 (1999). In the Southworth study, 21 subjects received the placebo treatment. 31
subjects received 20 minutes/day of cranial electrical stimulation. 31% of the experimental group improved versus
4% of the control group.
(^8) Id. at 199.
(^9) Edelmuth, R.C., Nitsche, M.A., Battistella, L. & Fregni, F., “Why Do Some Promising Brain-Stimulation Devices Fail
the Next Steps of Clinical Development?” Expert Rev Med Devices 7(1):67-97 (2010). doi: 10.1586/erd.09.64.
(^10) Smith, R.B., “A Summary Look at Studies of Cranial Electrotherapy Stimulation: Its First Fifty Years, Plus Three”
(monograph), published by Tate Publishing & Enterprises, Mustang, Oklahoma (2006). Available on line at
http://www.fisherwallace.com/published-research-on-cranial-electrotherapy-stimulation
(^11) Just seven of 18 studies were double-blind. Id. at 7.
(^12) Mischoulon, D., Summary and Critique of CES Monograph “Cranial Electrical Stimulation: Its First Fifty Years, Plus
Three” by Ray B Smith, PhD, monograph supplied by the author.
(^13) http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevic
esadvisorycommittee/neurologicaldevicespanel/ucm290787.pdf
(^14) The FDA's Neurological Devices Panel transcript and other meeting materials are available on FDA's Web site at
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevices
advisorycommittee/neurologicaldevicespanel/ucm291805.pdf and