Cranial electrotherapy stimulation

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

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][2]

CES technology has been regulated by the U.S. Food and Drug Administration (FDA) since 1977[3] and is classified as Class III by FDA.[4] Hundreds of thousands of patients have been treated with CES since 1960-s.[1] However, it is still being studied.[5][6]

History[edit]

"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.[7]

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.[8]

Modern research into low intensity electrical stimulation of the brain was begun by Leduc and Rouxeau in France (1902).[9][10][11] In 1949, the Soviet Union expanded research of CES to include the treatment of anxiety as well as sleeping disorders.[12]

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.[13]

CES was initially studied for insomnia and called electrosleep therapy;[14] it is also known as Cranial-Electro Stimulation[15] and Transcranial Electrotherapy.[16]

In 1972, a specific form of CES was developed by Dr. Margaret Patterson,[17][18] 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[edit]

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."[19]

In preparation to the 2012 Neurologic Devices Panel, FDA conducted its own CES literature review of the selected 39 papers, of which "some reported a beneficial effect of CES treatment on depression, anxiety and insomnia while others demonstrated no effect." FDA noted that "among studies that reported a clinical benefit of CES, few can be considered rigorous, high quality clinical studies."[3][20]

Soroush Zaghi et al. published an article in the journal The Neuroscientist finding that CES increases the production of serotonin, GABA, and endorphins.[8] These neurochemical changes explain any positive effects that might be experienced from CES.

A 1995 meta-analysis of anxiety by Klawansky et al. published in Journal of Nervous & Mental Disease "showed CES to be significantly more effective than sham treatment (p < .05)", 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.[5][6]

In 2006, Ray B. Smith published his meta-analysis on CES with a total of 67 studies and 2,910 patients analyzed. His CES research showed the following average improvement in particular disorders: 62% in insomnia, 47% in depression, 58% in anxiety, 60% in drug abstinence, 44% in cognitive dysfunction. Mean improvement showed to be very similar in all of the study designs.[1]

Computer modelling predictions using a highly detailed anatomical model show that CES induces significant currents in cortical, sub-cortical structures like thalamus, insula, and hypothalamus, and brain-stem structures.[21]

A bibliography by Kirsch (2002) listed 126 scientific studies of CES involving human subjects and 29 animal studies. 89% of the studies (112) had positive outcomes and 11% (14) were seen as having negative or indeterminate outcomes.[22]

A study published in Journal of Cognitive Rehabilitation found that 86% of the subjects tested showed improvements in their depression, 86% in state anxiety, and 90% in trait anxiety. An 18-month follow up found 18 of the original 23 subjects available to return for testing. Overall, they performed as well or better than in the original study.[23]

A pilot study showed that CES reduced the symptom burden of generalized anxiety disorder, with a decrease in Hamilton Anxiety Rating Scale (HAM-A) across a 6 week study, but the study had a small sample of participants and no control group.[24]

A systematic review which assessed 34 controlled trials involving a total of 767 CES patients and 867 control patients reported that in 77% of studies (26 of 34), CES was found to significantly reduce anxiety.[25]

CES research has been conducted in pain management[2][26] and the reduction of anxiety in patients undergoing dental procedures.[27]

A 3-week randomized controlled study which looked at insomnia in fibromyalgia patients found significant improvement in sleeping patterns.[28] In a longitudinal insomnia study, subjects showed improvement of symptoms during a two-year follow-up (p<0.0008).[29]

Several studies published in peer reviewed medical journals have found statistically significant results using CES in the treatment of depression,[30][31][32] and anxiety.[33][34][35][16][36] However, some of the early studies demonstrated a limited value of CES treatment for psychiatric inpatients.[37][38]

Regulation[edit]

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.[4][39]

As a result of the 1976 Medical Device Amendments, 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.

Some CES devices are also approved by Health Canada and have CE/ISO marks.[40][41]There are three major manufacturers of cranial electrotherapy stimulation (CES) in the United States and one in Canada.[citation needed]

Proposed mechanism of action[edit]

The exact mechanism of action of CES remains unclear but it is proposed that CES reduces the stress that underpins many emotional disorders. It is thought to act as an adaptogen, balancing physiological systems. This characteristic makes CES not addictive nor habit forming.[1]

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, thereby stabilizing the neurohormonal system.[42]

It has been proposed[42] 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. Computer modeling suggests that current of similar magnitudes maybe induced in both cortical and sub-cortical regions.[21] The prediction that CES induced current intensities in the sub-cortical structures are not sufficiently decreased from the cortical structures is potentially clinically meaningful.

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 levels 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.[43]

See also[edit]

References[edit]

  1. ^ a b c d Smith RB, Cranial Electrotherapy Stimulation: Its First Fifty Years
  2. ^ a b Kirsch, D. & , Smith, R.B. (2000). The use of cranial electrotherapy stimulation in the management of chronic pain: A review. PMID 11455071
  3. ^ a b FDA Executive Summary for February 10, 2012 Neurologic Devices Panel, fda.gov
  4. ^ a b 21CFR882.5800, Part 882 ("Neurological Devices")
  5. ^ a b 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. 
  6. ^ a b Stephen Barrett, M.D. (January 28, 2008). "Dubious Claims Made for NutriPax and Cranial Electrotherapy Stimulation". QuackWatch. 
  7. ^ Stillings D. A Survey Of The History Of Electrical Stimulation For Pain To 1900 Med.Instrum 9: 255-259 1975
  8. ^ a b 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
  9. ^ Leduc S. La narcose electrique. Ztschr. fur Electrother., 1903, XI, 1: 374-381, 403-410.
  10. ^ 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
  11. ^ L.A. Geddes (1965). Electronarcosis. Med.Electron.biol.Engng. Vol.3, pp. 11–26. Pergamon Press
  12. ^ 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.
  13. ^ 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. 
  14. ^ Appel, C. P. (1972). Effect of electrosleep: Review of research. Goteborg Psychology Report, 2, 1-24
  15. ^ Iwanovsky, A., & Dodge, C. H. (1968). Electrosleep and electroanesthesia–theory and clinical experience. Foreign Science Bulletin, 4 (2), 1-64
  16. ^ a b 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
  17. ^ 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.
  18. ^ Patterson MA. Electrotherapy: addictions and neuroelectric therapy. Nurs Times. 1979 Nov 29;75(48):2080-3. PubMed PMID 316129.
  19. ^ Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices, Federal Register
  20. ^ Comments to the FDA on possible reclassification of CES, Public Citizen
  21. ^ a b Datta, A., Dmochowski, J.P.,Guleyupoglu, B.,Bikson, M., Fregni, F.(2012) Cranial electrotherapy stimulation and transcranial pulsed current stimulation:A computer based high-resolution modeling study.Neuroimage. doi:10.1016/j.neuroimage.2012.09.062
  22. ^ Kirsch, Daniel L., "The Science Behind Cranial Electrotherapy Stimulation", 2nd edition, 2002
  23. ^ Smith, Ray B, "Cranial electrotherapy stimulation in the treatment of stress related cognitive dysfunction, with an eighteen month follow up." Journal of Cognitive Rehabilitation, 17(6):14-18, 1999.
  24. ^ Bystritsky, Alexander, Kerwin, Lauren and Feusner, Jamie. (2008). "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. 
  25. ^ De Felice EA. Cranial electrotherapy stimulation (CES) in the treatment of anxiety and other stress-related disorders: A review of controlled clinical trials. Stress Medicine. 1997;13(1):31-42.
  26. ^ 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
  27. ^ 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.
  28. ^ 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.
  29. ^ 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
  30. ^ 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
  31. ^ Smith R et al. Electrosleep in the management of alcoholism. Biological Psychiatry. 10(6):675 680, 1975
  32. ^ Smith R et al. The use of transcranial electrical stimulation in the treatment of cocaine and/or polysubstance abuse, 2002
  33. ^ Rosenthal SH. Electrosleep: A double-blind clinical study. Biological Psychiatry. 1972;4(2):179-185.
  34. ^ Philip P, Demotes-Mainard J, Bourgeois M, Vincent JD. Efficiency of transcranial electrostimulation on anxiety and insomnia symptoms during a washout period in depressed patients. A double-blind study. Biol Psychiatry. Mar 1 1991;29(5):451-456 doi:10.1016/0006-3223(91)90267-P PMID 2018818
  35. ^ Sousa AD, P.C. Choudhury. A psychometric evaluation of electrosleep. Indian Journal of Psychiatry. 1975;17:133-137
  36. ^ Ryan JJ SG. Effects of transcerebral electrotherapy (electrosleep) on state anxiety according to suggestibility levels. Biological Psychiatry. 1976;11(2):233-237
  37. ^ Levitt EA, James NM, Flavell P (December 1975). "A clinical trial of electrosleep therapy with a psychiatric inpatient sample". Aust N Z J Psychiatry 9 (4):287–90. doi:10.3109/00048677509159864 PMID 769773.
  38. ^ Feighner JP, Brown SL, Olivier JE (1973). "Electrosleep therapy. A controlled double blind study". J. Nerv. Ment. Dis. 157 (2): 121–8. doi:10.1097/00005053-197308000-00004 PMID 4724809
  39. ^ FDA Panel Votes to Curtail Cranial Electrotherapy Stimulators, Psychiatric Times
  40. ^ Health Canada Approves Drug-Free Treatment Fisher Wallace Stimulator® for Insomnia and Chronic Pain, Yahoo Finance
  41. ^ Jeff Marksberry The Management of Anxiety, Insomnia and Depression with Cranial Electrotherapy Stimulation (CES):Theory and Practice
  42. ^ a b Gilula MF, Kirsch DL. (2005). Cranial electrotherapy stimulation review: a safer alternative to psychopharmaceuticals in the treatment of depression. Journal of Neurotherapy, 9(2), 2005. doi:10.1300/J184v09n02_02
  43. ^ Kennerly, Richard. QEEG analysis of cranial electrotherapy: a pilot study. Journal of Neurotherapy (8)2, 2004.

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