![CES-Ultra-device-black](https://upload.wikimedia.org/wikipedia/commons/e/e4/CES-Ultra-device-black.jpg)
Cranial electrotherapy stimulation (CES) is a form of
neurostimulation
Neurostimulation is the purposeful modulation of the nervous system's activity using invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcr ...
that delivers a small, pulsed,
alternating current
Alternating current (AC) is an electric current which periodically reverses direction and changes its magnitude continuously with time in contrast to direct current (DC) which flows only in one direction. Alternating current is the form in whic ...
via electrodes on the head.
CES is used with the intention of treating a variety of conditions such as
anxiety
Anxiety is an emotion which is characterized by an unpleasant state of inner turmoil and includes feelings of dread over anticipated events. Anxiety is different than fear in that the former is defined as the anticipation of a future threat wh ...
,
depression and
insomnia
Insomnia, also known as sleeplessness, is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia is typically followed by daytime sleepiness, low energy, ...
.
[ CES has been suggested as a possible treatment for ]headache
Headache is the symptom of pain in the face, head, or neck. It can occur as a migraine, tension-type headache, or cluster headache. There is an increased risk of depression in those with severe headaches.
Headaches can occur as a result ...
s, fibromyalgia
Fibromyalgia (FM) is a medical condition defined by the presence of chronic widespread pain, fatigue, waking unrefreshed, cognitive symptoms, lower abdominal pain or cramps, and depression. Other symptoms include insomnia and a general hyp ...
, smoking cessation
Smoking cessation, usually called quitting smoking or stopping smoking, is the process of discontinuing tobacco smoking. Tobacco smoke contains nicotine, which is addictive and can cause dependence. As a result, nicotine withdrawal often make ...
, and opiate withdrawal,[ but there is little evidence of effectiveness for many of these conditions and the evidence for use in acute depression is not sufficient to justify it.][
]
Medical uses
A 2014 Cochrane review found insufficient evidence to determine whether or not CES with alternating current is safe and effective for treating depression. FDA came to the same conclusion in December 2019.
A 2018 systematic review found that evidence is insufficient that CES has clinically important effects on fibromyalgia
Fibromyalgia (FM) is a medical condition defined by the presence of chronic widespread pain, fatigue, waking unrefreshed, cognitive symptoms, lower abdominal pain or cramps, and depression. Other symptoms include insomnia and a general hyp ...
, headache, neuromusculoskeletal pain, degenerative joint pain, depression, or insomnia; low-strength evidence suggests modest benefit in patients with anxiety and depression.
Description
Electrodes are placed on the earlobes, maxilla-occipital junction, mastoid processes or temples.
Despite the long history of CES, its underlying principles and mechanisms are still not clear.[
CES stimulation of 1 mA (milliampere) has shown to reach the thalamic area at a radius of 13.30 mm. CES has shown to induce changes in the electroencephalogram, increasing alpha relative power and decreasing relative power in delta and beta frequencies.][
CES has also shown to reach cortical and subcortical areas of the brain, in electromagnetic tomography and ]functional MRI
Functional magnetic resonance imaging or functional MRI (fMRI) measures brain activity by detecting changes associated with blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area o ...
studies.[ CES treatments have been found to induce changes in neurohormones and neurotransmitters that have been implicated in psychiatric disorders: substantial increases in beta endorphins, adrenocorticotrophic hormone, and serotonin; moderate increases in melatonin and norepinephrine, modest or unquantified increases in cholinesterase, gamma-aminobutyric acid, and dehydroepiandrosterone, and moderate reductions in cortisol.][
]
History
Low intensity electrical stimulation is believed to have originated in the studies of galvanic currents in humans and animals as conducted by Giovanni Aldini
Giovanni Aldini (10 April 1762 – 17 January 1834) was an Italian physician and physicist born in Bologna. He was a brother of the statesman Count Antonio Aldini (1756–1826). He graduated in Physic at University of Bologna in 1782.
He became ...
, Alessandro Volta
Alessandro Giuseppe Antonio Anastasio Volta (, ; 18 February 1745 – 5 March 1827) was an Italian physicist, chemist and lay Catholic who was a pioneer of electricity and power who is credited as the inventor of the electric battery and the ...
and others in the 18th century. Aldini had experimented with galvanic head current as early as 1794 (upon himself) and reported the successful treatment of patients with melancholia
Melancholia or melancholy (from el, µέλαινα χολή ',Burton, Bk. I, p. 147 meaning black bile) is a concept found throughout ancient, medieval and premodern medicine in Europe that describes a condition characterized by markedly d ...
using direct
Direct may refer to:
Mathematics
* Directed set, in order theory
* Direct limit of (pre), sheaves
* Direct sum of modules, a construction in abstract algebra which combines several vector spaces
Computing
* Direct access (disambiguation), a ...
low-intensity currents in 1804.[Soroush Zaghi, Mariana Acar, Brittney Hultgren, Paulo S. Boggio, and Felipe Fregni. "Noninvasive Brain Stimulation with Low-Intensity Electrical Currents: Putative Mechanisms of Action for Direct and Alternating Current Stimulation." Neuroscientist. 2010 Jun;16(3):285–307 ]
CES was initially studied for insomnia and called electrosleep therapy; it is also known as cranial-electro stimulation and transcranial electrotherapy.[Gibson TH, Donald E. O'Hair. Cranial application of low level transcranial electrotherapy vs. relaxation instruction in anxious patients. American Journal of Electromedicine. 1987;4(1):18–21]
Due to the rise of pharmaceutical treatments for depression, anxiety and insomnia, such as Prozac
Fluoxetine, sold under the brand names Prozac and Sarafem, among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorde ...
in the 1980s and Ambien
Zolpidem, sold under the brand name Ambien, among others, is a medication primarily used for the short-term treatment of sleeping problems. Guidelines recommend that it be used only after cognitive behavioral therapy for insomnia and behavioral ...
in the 1990s, CES was not a well-known treatment for doctors and patients. During the mid-2000s, the combination of pharmaceutical brands becoming generic and Internet advertising caused CES devices to gain popularity. In 2011, the devices received media attention from the ''Wall Street Journal''.
Regulation
In the United States, CES technology is classified by the Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) as a Class III medical device and must be dispensed by or on the order of a licensed healthcare practitioner, i.e., a physician, psychiatrist, nurse practitioner, psychologist, physician assistant, or occupational therapist who has an appropriate electrotherapy license, dependent upon state regulations. The United States requires a prescription for CES devices from a licensed healthcare practitioner. The FDA says that there are 11 CES devices cleared for marketing in the United States.FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators
Psychiatric Times
In June 2014, the FDA announced that it "has determined that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices. In this action, FDA is withdrawing the proposed rule and proposed order to call for PMAs remarket approvalsfor CES devices. FDA plans to issue a proposed order in the future for the reclassification of the CES device into class II."[Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices]
Federal Register
In December 2019, the FDA announced that there is no valid evidence for CES as a treatment for depression, and request new trials to be made. "FDA concluded that the four studies published after January 1, 2016, through November 1, 2019, did not contribute sufficient information in the form of valid scientific evidence to demonstrate that the subjects met the criteria for any recognized depressive disorder, as defined in DSM-5" [Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression]
Federal Register
See also
* Transcranial direct-current stimulation
Transcranial direct current stimulation (tDCS) is a form of neuromodulation that uses constant, low direct current delivered via electrodes on the head. It was originally developed to help patients with brain injuries or neuropsychiatric conditio ...
* Transcranial magnetic stimulation
Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to induce an electric current at a specific area of the brain through electromagnetic induction. An electric pulse gener ...
* Electroconvulsive therapy
Electroconvulsive therapy (ECT) is a psychiatry, psychiatric treatment where a generalized seizure (without muscular convulsions) is electrically induced to manage refractory mental disorders.Rudorfer, MV, Henry, ME, Sackeim, HA (2003)"Electroco ...
References
{{DEFAULTSORT:Cranial Electrotherapy Stimulation
Medical treatments
Neurotechnology
Neuroscience
Electrotherapy
Medical devices