- Aldini^1 had experimented with galvanic head current as early as 1794 (upon himself) and
reported the successful treatment of patients suffering from melancholia using direct low-
intensity currents in 1804. - FDA approval of Transcranial Magnetic Stimulation in 2008 (see below) led to interest in
other forms of non-invasive brain stimulation. This includes, in particular, contrasting the
demonstrated polarizing effect of DC stimulation on brain tissue, which has long-term, site-
specific effects on the activity of the cortical nervous system, with the mechanism of AC
stimulation, which, while it can be shown to induce changes in central nervous system
activation, indexed by changes in EEG, neurotransmitter release, and cortical excitability,
cannot be explained by polarization. - At least eleven competing CES devices are on the market, of which four are pictured above.
The fifth picture is of a Transcranial Magnetic Stimulation device, which will be compared to
CES. According to Brown and Gerbarg, the most extensively studied CES devices are the
Alpha-Stim and the LISS Cranial Stimulator (now marketed by Fisher Wallace as the Fisher
Wallace Stimulator). The photo gallery depicts the two listed brands, plus the Oasis Pro and
CESta, from internet sources. MHA makes no representation about brand quality. - Of the consulted sources, only Brown et al. and Brown et al. II (the latter through Kirsch, D.L.
and Nichols, F., who are both associated with the manufacturer of the Alpha-Stim device)
discuss the use of Cranial Electrotherapy Stimulation (“CES”), a.k.a. Cranial Electrical
Stimulation or Cranial Electrostimulation, the alternating current version of this over fifty-
year-old therapy, grandfathered by the FDA as a Class III device for treatment of depression,
anxiety and sleep disorders.^2 An FDA proceeding is pending for Class II status, focused on its
use in people recovering from substance use conditions. At least six competing devices are
on the market, of which five are pictured above. - In January of 2016, the FDA proposed reclassifying CES devices as Class II devices for
insomnia and/or anxiety^3 , but with restrictive special conditions:
sharon
(sharon)
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