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Updating to reflect most recent ruling by regulatory body, FDA, in 2014. Prior edit references rulings from the same regulatory body, but in 2012.
Removing redundancies and references to obsolete FDA rulings. 2014 ruling is most recent and reflective of current status of FDA's current stance on Cranial Electrotherapy Stimulation.
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'''Cranial electrotherapy stimulation''' ('''CES''') is a form of [[Invasiveness of surgical procedures|non-invasive]] brain stimulation that applies a small, pulsed electric current across a patient's head to treat [[anxiety]], [[clinical depression|depression]], [[insomnia]] and [[chronic pain]].<ref name=Medscape> {{cite web |url= http://www.medscape.com/viewarticle/758820 |title= Electrical Stimulators Need High-Risk Rating, Says FDA Panel |author= Shelley A |date= February 17, 2012 |accessdate= February 21, 2015 |publisher= Medscape Medical News}}</ref>
'''Cranial electrotherapy stimulation''' ('''CES''') is a form of [[Invasiveness of surgical procedures|non-invasive]] brain stimulation that applies a small, pulsed electric current across a patient's head to treat [[anxiety]], [[clinical depression|depression]], [[insomnia]] and [[chronic pain]].<ref name=Medscape> {{cite web |url= http://www.medscape.com/viewarticle/758820 |title= Electrical Stimulators Need High-Risk Rating, Says FDA Panel |author= Shelley A |date= February 17, 2012 |accessdate= February 21, 2015 |publisher= Medscape Medical News}}</ref>

CES technology has been regulated by the U.S. [[Food and Drug Administration]] (FDA) since 1977<ref name=FDA_Panel>[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM290787.pdf FDA Executive Summary for February 10, 2012 Neurologic Devices Panel], fda.gov</ref> and is classified as [[Medical device#Class III: General controls and premarket approval|Class III]] "for devices that have insufficient information or are life-supporting, life-sustaining, or present an unreasonable risk for illness or injury".<ref name=Medscape/>


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."<ref>[https://www.federalregister.gov/articles/2014/06/12/2014-13756/neurological-devices-withdrawal-of-proposed-effective-date-of-requirement-for-premarket-approval-for Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices], Federal Register</ref>
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."<ref>[https://www.federalregister.gov/articles/2014/06/12/2014-13756/neurological-devices-withdrawal-of-proposed-effective-date-of-requirement-for-premarket-approval-for Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices], Federal Register</ref>


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 [[Health care provider|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.<ref name=FDA_CFR>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5800 21CFR882.5800, Part 882 ("Neurological Devices")]</ref><ref>[http://www.psychiatrictimes.com/neuropsychiatry/fda-panel-votes-curtail-cranial-electrotherapy-stimulators FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators], Psychiatric Times</ref>
CES technology has been [[FDA]]-regulated since 1977<ref name=FDA_Panel>[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM290787.pdf FDA Executive Summary for February 10, 2012 Neurologic Devices Panel], fda.gov</ref> and is currently classified as [[Medical device#Class III: General controls and premarket approval|Class III]] by FDA.<ref name=FDA_CFR/> Hundreds of thousands of patients have been treated with CES since 1960-s.<ref name=Smith/> However, it's still being studied.<ref name=Klawansky/><ref name=Barrett/>



==Effectiveness==
==Effectiveness==
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==Regulation==
==Regulation==
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."<ref>[https://www.federalregister.gov/articles/2014/06/12/2014-13756/neurological-devices-withdrawal-of-proposed-effective-date-of-requirement-for-premarket-approval-for Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices], Federal Register</ref>

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 [[Health care provider|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.<ref name=FDA_CFR>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5800 21CFR882.5800, Part 882 ("Neurological Devices")]</ref><ref>[http://www.psychiatrictimes.com/neuropsychiatry/fda-panel-votes-curtail-cranial-electrotherapy-stimulators FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators], Psychiatric Times</ref>
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 [[Health care provider|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.<ref name=FDA_CFR>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5800 21CFR882.5800, Part 882 ("Neurological Devices")]</ref><ref>[http://www.psychiatrictimes.com/neuropsychiatry/fda-panel-votes-curtail-cranial-electrotherapy-stimulators FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators], Psychiatric Times</ref>

CES technology has been [[FDA]]-regulated since 1977<ref name=FDA_Panel>[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM290787.pdf FDA Executive Summary for February 10, 2012 Neurologic Devices Panel], fda.gov</ref> and is currently classified as [[Medical device#Class III: General controls and premarket approval|Class III]] by FDA.<ref name=FDA_CFR/> Hundreds of thousands of patients have been treated with CES since 1960-s.<ref name=Smith/> However, it's still being studied.<ref name=Klawansky/><ref name=Barrett/>



Some CES devices are also approved by [[Health Canada]] and have [[CE marking|CE]]/[[ISO]] marks.<ref>[http://finance.yahoo.com/news/health-canada-approves-drug-free-143000015.html Health Canada Approves Drug-Free Treatment Fisher Wallace Stimulator® for Insomnia and Chronic Pain], Yahoo Finance</ref>
Some CES devices are also approved by [[Health Canada]] and have [[CE marking|CE]]/[[ISO]] marks.<ref>[http://finance.yahoo.com/news/health-canada-approves-drug-free-143000015.html Health Canada Approves Drug-Free Treatment Fisher Wallace Stimulator® for Insomnia and Chronic Pain], Yahoo Finance</ref>

Revision as of 19:59, 18 July 2015

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.[1]

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."[2]

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.[3][4]


Effectiveness

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."[5] A 1995 meta-analysis of CES for the treatment of anxiety found it better than "sham", 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.[6]

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.[3][7]

Some CES devices are also approved by Health Canada and have CE/ISO marks.[8]

Proposed mechanism of action

The exact mechanism of action of CES is unclear.[9]

History

"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.[10]

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.[11]

Modern research into low intensity electrical stimulation of the brain was begun by Leduc and Rouxeau in France (1902).[12][13][14] In 1949, the Soviet Union expanded research of CES to include the treatment of anxiety as well as sleeping disorders.[15]

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.

CES was initially studied for insomnia and called electrosleep therapy;[16] it is also known as cranial-electro stimulation[17] and transcranial electrotherapy.[18]

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. ^ Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices, Federal Register
  3. ^ a b 21CFR882.5800, Part 882 ("Neurological Devices")
  4. ^ FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators, Psychiatric Times
  5. ^ Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices, Federal Register
  6. ^ Sidney Klawansky (July 1995). "Meta-Analysis of Randomized Controlled Trials of Cranial Electrostimulation: Efficacy in Treating Selected Psychological and Physiological Conditions". Journal of Nervous & Mental Disease. 183 (7): 478–484. doi:10.1097/00005053-199507000-00010.
  7. ^ FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators, Psychiatric Times
  8. ^ Health Canada Approves Drug-Free Treatment Fisher Wallace Stimulator® for Insomnia and Chronic Pain, Yahoo Finance
  9. ^ Cite error: The named reference Rosa was invoked but never defined (see the help page).
  10. ^ Stillings D. A Survey Of The History Of Electrical Stimulation For Pain To 1900 Med.Instrum 9: 255-259 1975
  11. ^ 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
  12. ^ Leduc S. La narcose electrique. Ztschr. fur Electrother., 1903, XI, 1: 374-381, 403-410.
  13. ^ Leduc S., Rouxeau A. Influence du rythme et de la period sur la production de l'inhibition par les courants intermittents de basse tension. C.R. Seances Soc.Biol., 1903,55, VII-X : 899-901
  14. ^ L.A. Geddes (1965). Electronarcosis. Med.Electron.biol.Engng. Vol.3, pp. 11–26. Pergamon Press
  15. ^ Гиляровский В.А., Ливенцев Н.М., Сегаль Ю.Е., Кириллова З.А. Электросон (клинико-физиологическое исследование). М., "Медгиз", 2 изд. М., "Медгиз", 1958, 166 с.
  16. ^ Appel, C. P. (1972). Effect of electrosleep: Review of research. Goteborg Psychology Report, 2, 1-24
  17. ^ Iwanovsky, A., & Dodge, C. H. (1968). Electrosleep and electroanesthesia–theory and clinical experience. Foreign Science Bulletin, 4 (2), 1-64
  18. ^ 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

Further reading

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