Cranial electrotherapy stimulation
Cranial electrotherapy stimulation (CES) is a form of non-invasive brain stimulation that applies a small, pulsed electric current across a person's head to treat anxiety, depression, insomnia and chronic pain.
A 2014 Cochrane review found insufficient evidence to determine whether or not CES with alternating current is safe and effective for treating depression. On June 2014, the Food and Drug Administration concluded that there is sufficient information to provide a reasonable assurance of safety and effectiveness for CES devices.
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.
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 for CES devices. FDA plans to issue a proposed order in the future for the reclassification of the CES device into class II."
Mechanism of action
Despite the long history of CES, its underlying principles and mechanisms are still not clear.
"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.
- Shelley A (February 17, 2012). "Electrical Stimulators Need High-Risk Rating, Says FDA Panel". Medscape Medical News. Retrieved February 21, 2015.
- Kavirajan HC, Lueck K, Chuang K (2014). "Alternating current cranial electrotherapy stimulation (CES) for depression". Cochrane Database Syst Rev 7: CD010521. doi:10.1002/14651858.CD010521.pub2. PMID 25000907.
Rigorous clinical trial evidence is lacking on the use of cranial electrotherapy stimulation (CES) in acute depression. Thus, at present, there is insufficient evidence on which to base decisions for using CES in treatment of acute depression
- Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices, Federal Register
- 21CFR882.5800, Part 882 ("Neurological Devices")
- FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators, Psychiatric Times
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