Cranial electrotherapy stimulation

Cranial electrotherapy stimulation
Cranial electrotherapy stimulation
Alternative medicine / fringe therapies
Claims Electrical stimulation of the scalp can relieve various psychological disorders.

Cranial Electrotherapy Stimulation (CES) is an experimental[1] psychiatric treatment that applies a small, pulsed electric current across a patient's head. It has been claimed to have beneficial effects in conditions such as anxiety, depression, insomnia and stress.[2] However, its effectiveness is still being studied.[3][4]

Contents

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.[5]

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.[6] 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]

Modern research into low intensity electrical stimulation of the brain was begun by Leduc and Rouxeau in France (1902).[7][8][9] In 1949, the Soviet Union expanded research of CES to include the treatment of anxiety as well as sleeping disorders.[10]

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.[11]

CES was initially studied for insomnia [12] and called electrosleep therapy[13]; it is also known as Cranial-Electro Stimulation [14] and Transcranial Electrotherapy[15].

In 1972, a specific form of CES was developed by Dr. Margaret Patterson, [16][17] 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)".

Effectiveness

A meta-analysis by Harvard University School of Public Health found significant improvement in one measure (anxiety) after CES, but noted that 90% of the studies included in the review were inadequately blinded and the experimenter "knew which patients were receiving CES or sham treatment."[3] Most studies cited as evidence for the effectiveness of CES failed to report all data necessary for meta-analysis.[3][4]

A bibliography by Kirsch (2002) [18]listed 126 scientific studies of CES involving human subjects and 29 animal studies [19]. An estimated 145 human studies have been completed, encompassing over 8800 people receiving active CES.[20]

A pilot study showed that CES reduced the symptom burden of generalized anxiety disorder, with a decrease in Hamilton Anxiety Rating Scale (HARS) across a 6 week study, but the study had a small sample of participants and no control group.[21]

CES research has been conducted in pain management [22] [23] and the reduction of anxiety in patients undergoing dental procedures.[24].

A 3-week randomized controlled study which looked at insomnia in fibromyalgia patients found significant improvement in sleeping patterns.[25] In a longitudinal insomnia study, subjects showed improvement of symptoms during a two-year follow-up (p<0.0008).[26]

Studies have found statistically significant results in the treatment of depression with CES.[27][28][29]

Regulation

In the United States, CES technology is classified by the Food and Drug Administration as Class III medical devices and must be dispensed by or on the order of a licensed healthcare practitioners, i.e. a physician, psychiatrist or nurse practitioner; psychologists, physician assistants, and occupational therapists who have an appropriate electrotherapy license may prescribe CES, dependent upon state regulations.[1][30]

As a result of the 1976 Medical Device Amendments, CES was placed in Class III by the FDA. 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.

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.[2] 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 stabilizing the neurohormonal system.[31]

It has been proposed [32] 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. All modern analysis using computer simulation to predict current flow through the brain, however, suggest that CES has no spatial focality and may result in current passing through most of the brain [33].

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 its level 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.[34]

See also

References

  1. ^ a b 21CFR882.5800, Part 882 ("Neurological Devices")
  2. ^ a b Smith RB, Cranial Electrotherapy Stimulation: Its First Fifty Years
  3. ^ a b c 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. http://www.jonmd.com/pt/re/jnmd/abstract.00005053-199507000-00010.htm. 
  4. ^ a b Stephen Barrett, M.D. (January 28, 2008). "Dubious Claims Made for NutriPax and Cranial Electrotherapy Stimulation". QuackWatch. http://www.quackwatch.com/01QuackeryRelatedTopics/ces.html. 
  5. ^ Stillings D. A Survey Of The History Of Electrical Stimulation For Pain To 1900 Med.Instrum 9: 255-259 1975
  6. ^ a b Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. (2009). Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. The Neuroscientist
  7. ^ Leduc S. La narcose electrique. Ztschr. fur Electrother., 1903, XI, 1: 374-381, 403-410.
  8. ^ 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
  9. ^ L.A. Geddes (1965). Electronarcosis. Med.Electron.biol.Engng. Vol.3, pp. 11–26. Pergamon Press
  10. ^ 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.
  11. ^ Bystritsky, A, Kerwin, L and Feusner, J (2008). "A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder". Journal of Clinical Psychiatry 69 (3): 412–417. doi:10.4088/JCP.v69n0311. PMID 18348596. 
  12. ^ Appel, C. P. (1972). Effect of electrosleep: Review of research. Goteborg Psychology Report, 2, 1-24
  13. ^ doi:10.1300/J184v09n02_02
  14. ^ Iwanovsky, A., & Dodge, C. H. (1968). Electrosleep and electroanesthesia–theory and clinical experience. Foreign Science Bulletin, 4 (2), 1-64
  15. ^ DOI: 10.1007/s11940-008-0040-y
  16. ^ Dr. Margaret A. Patterson. Effects of Neuro-Electric Therapy (N.E.T.) In Drug Addiction: Interim Report. Bull Narc. 1976 Oct-Dec;28(4):55-62. PubMed PMID: 1087892.
  17. ^ Patterson MA. Electrotherapy: addictions and neuroelectric therapy. Nurs Times. 1979 Nov 29;75(48):2080-3. PubMed PMID: 316129.
  18. ^ Kirsch, D. L. (2002). The science behind cranial electrotherapy stimulation. Edmonton, Alberta: Medical Scope Publishing
  19. ^ doi:10.1300/J184v09n02_02
  20. ^ Kirsch, Daniel L., "Science Behind Cranial Electrotherapy Stimulation", 2nd edition, 2002
  21. ^ Bystritsky, Alexander, Kerwin, Lauren and Feusner, Jamie. (2008 url=http://www.ncbi.nlm.nih.gov/pubmed/18348596).&#32;"A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder.". Journal of Clinical Psychiatry 69: 412–417. doi:10.4088/JCP.v69n0311. PMID 18348596. 
  22. ^ Kirsch, D. & , Smith, R.B. (2000). The use of cranial electrotherapy stimulation in the management of chronic pain: A review. NeuroRehabilitation, 14, 85-94
  23. ^ P. Cevei, M. Cevei and I. Jivet. (2011) Experiments in Electrotherapy for Pain Relief Using a Novel Modality Concept. IFMBE, Volume 36, Part 2, 164-167. DOI: 10.1007/978-3-642-22586-4_35
  24. ^ Winick, Reid L. Cranial electrotherapy stimulation (CES): a safe and effective low cost means of anxiety control in a dental practice. General Dentistry. 47(1):50-55, 1999.
  25. ^ Lichtbroun, A.S., Raicer, M.M.C. and Smith, R.B. The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology. 7(2):72-78, 2001.
  26. ^ Weiss, Marc F. The treatment of insomnia through use of electrosleep: an EEG study. Journal of Nervous and Mental Disease. 157(2):108 120, 1973
  27. ^ Matteson M et al. An exploratory investigation of CES as an employee stress management technique. Journal of Health and Human Resource Administration. 9:93 109, 1986
  28. ^ Smith R et al. Electrosleep in the management of alcoholism. Biological Psychiatry. 10(6):675 680, 1975
  29. ^ Smith R et al. The use of transcranial electrical stimulation in the treatment of cocaine and/or polysubstance abuse, 2002
  30. ^ FDA medical device classifications
  31. ^ Gilula MF, Kirsch DL. (2005). Cranial electrotherapy stimulation review: a safer alternative to psychopharmaceuticals in the treatment of depression. Journal of Neurotherapy, 9(2), 63-77.
  32. ^ Gilula, M.F. & Kirsch, D.L. Cranial Electrotherapy Stimulation Review: A Safer Alternative to Psychopharmaceuticals in the Treatment of Depression. Journal of Neurotherapy, Vol. 9(2) 2005. doi:10.1300/J184v09n02_02
  33. ^ Zaghi, S. et. al. (2009) Noninvasive Brain Stimulation with Low-Intensity Electrical Currents: Putative Mechanisms of Action for Direct and Alternating Current Stimulation. The Neuroscientist.December 29, 2009 as doi:10.1177/1073858409336227
  34. ^ Kennerly, Richard. QEEG analysis of cranial electrotherapy: a pilot study. Journal of Neurotherapy (8)2, 2004.

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