Cranial electrotherapy stimulation (CES), also referred to as cranial electrical stimulation, transcranial electrical stimulation, or electrical stimulation therapy, is a noninvasive procedure being evaluated as a treatment for a variety of conditions, including pain, insomnia, depression, anxiety, mood disorders and weight loss. Low levels of direct electrical current are applied via electrodes clipped to the ear lobes, mastoid processes or scalp (e.g. Elexoma™ Medic, CES Ultra™, Alpha-Stim®).
The mechanism of action is thought to be the modulation of activity in brain networks by direct action in the hypothalamus, limbic system, and/or the reticular activating system. This device can be used in the home setting. Treatments may last several hours and can be administered once or twice daily for a period of several days to several weeks.
Cranial electrotherapy stimulation is considered investigational.
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Randomized controlled trials have not consistently demonstrated an improvement in health outcomes. The largest body of evidence is for depression and anxiety. For this indication, in two of three sham-controlled trials, no differences were reported in outcomes between groups. The evidence is insufficient to determine the effects of the technology on health outcomes.
Barclay, T. & Barclay, R. (2014). A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. Journal of Affective Disorders, 164, 171-177. Abstract retrieved October 20, 2017 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2018). Cranial electrotherapy stimulation and auricular electrostimulation (8.01.58). Retrieved August 28, 2018 from BlueWeb. (18 articles and/or guidelines reviewed)
Gong, B., Ma, H., Zang, X., Wang, S., Zhang, Y., Jiang, N., et al. (2016). Efficacy of cranial electrotherapy stimulation combined with biofeedback therapy in patients with functional constipation. Journal of Neurogastroenterology and Motility, 22 (3), 497-508. (Level 2 evidence)
U.S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database, K062284. Retrieved October 20, 2017 from https://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, December) Transcranial Direct Current Stimulation for Depression. Retrieved August 28, 2018 from www.hayesinc.com.
ORIGINAL EFFECTIVE DATE: 8/13/2005
MOST RECENT REVIEW DATE: 11/8/2018
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