Cranial electrotherapy stimulation
|Claims||Electrical stimulation of the scalp can relieve various psychological disorders.|
Cranial Electrotherapy Stimulation (CES) is a form of non-invasive brain stimulation that applies a small, pulsed electric current across a patient's head to treat anxiety, depression, insomnia and chronic pain.
CES technology has been regulated by the U.S. Food and Drug Administration (FDA) since 1977 and is classified as Class III by FDA. Hundreds of thousands of patients have been treated with CES since 1960-s. However, it is still being studied.
"Electrotherapy" has been in use for at least 2000 years, as shown by the clinical literature of the early Roman physician, Scribonius Largus, who wrote in the Compositiones Medicae of 46 AD that his patients should stand on a live black torpedo fish for the relief of a variety of medical conditions, including gout and headaches. Claudius Galen (131 - 201 AD) also recommended using the shocks from the electrical fish for medical therapies.
Low intensity electrical stimulation is believed to have originated in the studies of galvanic currents in humans and animals as conducted by Giovanni Aldini, Alessandro Volta 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 suffering from melancholia using direct low-intensity currents in 1804.
Modern research into low intensity electrical stimulation of the brain was begun by Leduc and Rouxeau in France (1902). In 1949, the Soviet Union expanded research of CES to include the treatment of anxiety as well as sleeping disorders.
In the 1960s and 1970s, it was common for physicians and researchers to place electrodes on the eyes, thinking that any other electrode site would not be able to penetrate the cranium. It was later found that placing electrodes on the earlobes was far more convenient, and quite effective.
In 1972, a specific form of CES was developed by Dr. Margaret Patterson, providing small pulses of electric current across the head to ameliorate the effects of acute and chronic withdrawal from addictive substances. She named her treatment "NeuroElectric Therapy (NET)".
In its announcement made on June 12, 2014, FDA "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 for CES devices. FDA plans to issue a proposed order in the future for the reclassification of the CES device into class II."
In preparation to the 2012 Neurologic Devices Panel, FDA conducted its own CES literature review of the selected 39 papers, of which "some reported a beneficial effect of CES treatment on depression, anxiety and insomnia while others demonstrated no effect." FDA noted that "among studies that reported a clinical benefit of CES, few can be considered rigorous, high quality clinical studies."
Soroush Zaghi et al. published an article in the journal The Neuroscientist finding that CES increases the production of serotonin, GABA, and endorphins. These neurochemical changes explain any positive effects that might be experienced from CES.
A 1995 meta-analysis of anxiety by Klawansky et al. published in Journal of Nervous & Mental Disease "showed CES to be significantly more effective than sham treatment (p < .05)", but noted that 86% of the studies included in the review were inadequately blinded and the experimenter "knew which patients were receiving CES or sham treatment." Most studies cited as evidence for the effectiveness of CES failed to report all data necessary for meta-analysis.
In 2006, Ray B. Smith published his meta-analysis on CES with a total of 67 studies and 2,910 patients analyzed. His CES research showed the following average improvement in particular disorders: 62% in insomnia, 47% in depression, 58% in anxiety, 60% in drug abstinence, 44% in cognitive dysfunction. Mean improvement showed to be very similar in all of the study designs.
Computer modelling predictions using a highly detailed anatomical model show that CES induces significant currents in cortical, sub-cortical structures like thalamus, insula, and hypothalamus, and brain-stem structures.
A bibliography by Kirsch (2002) listed 126 scientific studies of CES involving human subjects and 29 animal studies. 89% of the studies (112) had positive outcomes and 11% (14) were seen as having negative or indeterminate outcomes.
A study published in Journal of Cognitive Rehabilitation found that 86% of the subjects tested showed improvements in their depression, 86% in state anxiety, and 90% in trait anxiety. An 18-month follow up found 18 of the original 23 subjects available to return for testing. Overall, they performed as well or better than in the original study.
A pilot study showed that CES reduced the symptom burden of generalized anxiety disorder, with a decrease in Hamilton Anxiety Rating Scale (HAM-A) across a 6 week study, but the study had a small sample of participants and no control group.
A systematic review which assessed 34 controlled trials involving a total of 767 CES patients and 867 control patients reported that in 77% of studies (26 of 34), CES was found to significantly reduce anxiety.
A 3-week randomized controlled study which looked at insomnia in fibromyalgia patients found significant improvement in sleeping patterns. In a longitudinal insomnia study, subjects showed improvement of symptoms during a two-year follow-up (p<0.0008).
Several studies published in peer reviewed medical journals have found statistically significant results using CES in the treatment of depression, and anxiety. However, some of the early studies demonstrated a limited value of CES treatment for psychiatric inpatients.
In the United States, CES technology is classified by the Food and Drug Administration as a Class III medical device and must be dispensed by or on the order of a licensed healthcare practitioners, i.e., a physician, psychiatrist or nurse practitioner; psychologist, physician assistant, or occupational therapist who has an appropriate electrotherapy license, dependent upon state regulations.
As a result of the 1976 Medical Device Amendments, manufacturers who prove both safety and efficacy may enter the market, with FDA clearance, utilizing the 510(k) process instead of the premarket approval process, at this time.
Some CES devices are also approved by Health Canada and have CE/ISO marks.There are three major manufacturers of cranial electrotherapy stimulation (CES) in the United States and one in Canada.
Proposed mechanism of action
The exact mechanism of action of CES remains unclear but it is proposed that CES reduces the stress that underpins many emotional disorders. It is thought to act as an adaptogen, balancing physiological systems. This characteristic makes CES not addictive nor habit forming.
The proposed mechanism of action for CES is that the pulses of electric current increase the ability of neural cells to produce serotonin, dopamine, DHEA, endorphins and other neurotransmitters, thereby stabilizing the neurohormonal system.
It has been proposed that during CES, an electric current is focused upon the hypothalamic region; during this process, CES electrodes are placed on the ear at the mastoid, near to the face. Computer modeling suggests that current of similar magnitudes maybe induced in both cortical and sub-cortical regions. The prediction that CES induced current intensities in the sub-cortical structures are not sufficiently decreased from the cortical structures is potentially clinically meaningful.
It has been suggested that the current results in an increase of the brain's levels of serotonin, norepinephrine, and dopamine, and a decrease in levels of cortisol. After a CES treatment, users are in an "alert, yet relaxed" state, characterized by increased alpha and decreased delta brain waves as seen on EEG.
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