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.[1] Electrodes are placed on the ear lobes, maxilla-occipital junction, mastoid processes or temples.[2]

Effectiveness

A 2014 Cochrane review found insufficient evidence to determine whether or not CES with alternating current is safe and effective for treating depression.[3]

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.[4]

Despite the long history of CES, its underlying principles and mechanisms are still not clear.[5]

Proposed mechanism of action

CES stimulation of 1 mA (miliampere) 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.[2]

CES has also shown to also reach cortical and subcortical areas of the brain, in electromagnetic tomography and functional mri studies.[2] 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.[2]

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, 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.[6]

CES was initially studied for insomnia and called electrosleep therapy;[7] it is also known as cranial-electro stimulation[8] and transcranial electrotherapy.[9]

In 1972, a specific form of CES was developed by Dr. Margaret Patterson. The treatment used small pulses of electric current across the head for acute and chronic withdrawal from addictive substances. It was named "NeuroElectric Therapy (NET)." CES is a prescription device, which became available in the United States in 1963 as Electrosleep. The device was grandfathered into modern FDA regulation in 1976 as a Class III device under the Medical Device Amendments Act of 1976, when the name was changed to Cranial Electrotherapy Stimulation.[10]

Due to the rise of pharmaceutical treatments for depression, anxiety and insomnia, such as Prozac in the 1980's and Ambien in the 1990's, CES was not a well-known treatment for doctors and patients. During the mid-2000's, 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.[11]

Regulation

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. The United States requires a prescription for CES devices from a licensed healthcare practitioner. The FDA indicates that there are 11 CES devices cleared for marketing in the United States.[12][13]

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."[4]

CES is approved by Health Canada for over-the-counter treatment of insomnia and chronic pain.[14] CES is also approved by the European Union for over-the-counter treatment of depression, anxiety and insomnia.[15]

See also

References

  1. ↑ Shelley A (February 17, 2012). "Electrical Stimulators Need High-Risk Rating, Says FDA Panel". Medscape Medical News. Retrieved February 21, 2015.
  2. 1 2 3 4 "Cranial Electrotherapy Stimulation for Treatment of Anxiety, Depression, and Insomnia" (PDF). Psychiatric Clinics of North America. Retrieved 17 January 2016.
  3. ↑ 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
  4. 1 2 Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices, Federal Register
  5. ↑ Rosa MA, Lisanby SH (2012). "Somatic treatments for mood disorders". Neuropsychopharmacology 37 (1): 102–16. doi:10.1038/npp.2011.225. PMC 3238088. PMID 21976043.
  6. ↑ 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 doi:10.1177/1073858409336227
  7. ↑ Appel, C. P. (1972). Effect of electrosleep: Review of research. Goteborg Psychology Report, 2, 1-24
  8. ↑ Iwanovsky, A., & Dodge, C. H. (1968). Electrosleep and electroanesthesia–theory and clinical experience. Foreign Science Bulletin, 4 (2), 1-64
  9. ↑ 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
  10. ↑ Daniel L. Kirsch (2002). "The Science Behind Cranial Electrotherapy Stimulation" (PDF). Medical Scope Publishing Corporation. Retrieved February 23, 2016.
  11. ↑ Melinda Beck (January 11, 2011). "Using Electricity, Magnets for Mental Illness". The Wall Street Journal. Retrieved February 23, 2016.
  12. ↑ 21CFR882.5800, Part 882 ("Neurological Devices")
  13. ↑ FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators, Psychiatric Times
  14. ↑ Tom Blackwell (June 12, 2013). "Do-it-yourself brain stimulation has scientists worried as healthy people try to make their minds work better". National Post.
  15. ↑ Gilula, Marshall F. and Barach, Paul R. (2014). "Cranial Electrotherapy Stimulation: a Safe Neuromedical Treatment for Anxiety, Depression or Insomnia". Southern Medical Journal.

Further reading

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