Cranial electrotherapy stimulation (CES), (also known as “electrosleep”, “transcranial electrotherapy” and by many other names), involves a form of treatment that sends low intensity microcurrent (under 1 milliampere) to the brain. [1] CES devices function differently from other biomedical electronics, such as deep brain stimulating electrodes (which prevent seizures and hand tremors) [2] and heart pacemakers. While those instruments require surgical implantation, CES operates non-invasively. Designed for home use, the devices deliver current to the brain via a hand held machine to electrodes attached on or behind the ears. [3]

Uses for Brain Health

A wide body of research suggests that the technique effectively treats insomnia, depression and anxiety (the only FDA approved uses). Scientific data also shows promise for other conditions such as pain, tension/migraine headaches, fibromyalgia, and ADHD. CES might also provide benefits for chemical dependencies (such as street and prescription drugs, alcohol, and tobacco); that is, it might help the insomnia, anxiety and depression that often manifest during withdrawal. [4,5]

Patient Experience

The devices, sold by prescription in the U.S., require initial assessment and ongoing medical follow-up. [6] Treatment protocols vary based upon the health issue and the phase of treatment. Therefore, patients with anxiety typically use devices for 20-60 minutes daily for the first 2 to 3 weeks, with less frequent use thereafter. [7] Users may do other things during treatment (such as read, watch TV), but should not drive or operate machinery during or shortly after treatment. [8]

Individual responses may vary, but most users report reduced symptoms (such as anxiety) after their first or second treatment. Severe depression however, may require three weeks for therapeutic results. During use, patients often experience pleasant mental states with increased muscle relaxation yet enhanced mental clarity. They might also feel a pulsing or tingling, sensation in their earlobes, (considered normal), which setting adjustments can alleviate. Positive effects after a single treatment may last up to two days and effects usually become cumulative. [9]

Brain Effects

Researchers don’t fully understand mechanisms involved, but theorize that CES electrical current helps reestablish optimal brain chemistry and improves efficiency of neural connections. [10] One example of research supporting this theory involves electrical engineering simulations conducted by researchers at the University of Texas, Austin. Their brain mapping techniques suggested that minute amounts of current traveled to the brain’s thalamus, enough to enable release of neurotransmitters. [11] Other research conducted by North Dakota State University utilized EEG techniques to quantify changes during administration of CES versus sham treatment. The research showed frequency distribution shifts suggestive of beneficial changes. [12]

Based on current and ongoing research, neuroscientist Dr. James Giordano postulates that CES microcurrent travels to the base of the brain (the brainstem), activating clusters of nerve cells which make the brain chemicals serotonin and acetylcholine. Serotonin is linked to relaxation [13] while acetylcholine is linked to body processes not under conscious control while at rest. [14] Released by nerve cells at the synapse, these neurotransmitters influence pathways within the brain and spinal cord that inhibit arousal and agitation. The resulting “fine tuning” helps the nervous system to restore homeostatic balance and possibly creates brain patterns known as alpha rhythms. Measurable via brain wave recordings (called EEG); scientists often associate alpha states with enhanced mental focus and relaxation. Neurological processes linked to alpha states seem to reduce stress, stabilize mood, and exert control over certain types of pain.

Effectiveness

Scientists conducted much of the early work on CES in France. Starting work in the early 1900’s, they theorized that minute amounts of current (applied to the head) would calm the central nervous system, inducing a sleep-like state. [16] The technique took hold in the West in the late 1960’s, when Austria hosted International Symposia on the topic. The uneven quality of studies published up until that time however, generated skepticism as well as further research. Still in progress, the scientific community has accumulated years of research, which spans the past century. [17]

In his recently revised book, The Science Behind Cranial Electrotherapy Stimulation, Daniel L. Kirsch reviewed CES research from the last 40 years which includes 126 human and 29 animal studies, and 31 review articles. Over half came from peer-reviewed sources and most, coming from major US universities used double blind techniques. Of studies reviewed, 112 (89%), claimed positive results. Seventeen follow-up studies evaluating residual effects (lasting 1 week to 2 years) showed at least some continuing effect in all of the patients. [18]

While a body of published research does exist, some have reservations. Research design and quality varies widely and very few peer reviewed journals are publishing recent studies. Complicating matters, makers of the device often lack proper funding to support high quality research. [19] Others think the technique needs more study in terms of practicality and cost effectiveness. [20]

As a way to clarify CES efficacy, medical researchers from the Harvard School of Public Health published a thorough scientific review of CES devices. Their report identified 18 of the most rigorous studies of CES versus sham treatment. They then applied meta-analysis to 14 of those studies, using combined results to further discern effects after treating four different conditions. [21] Reconfirming previous meta-analysis by University of Tulsa researchers, [22] pooling techniques showed CES to be significantly more effective for treating anxiety; but they did not affect results for insomnia, headache, and brain dysfunction. The review team made comment that most studies under scrutiny needed to publish more complete data and blind treatment providers from knowing which patients were getting CES. [23]

Safety/Precautions

CES has an excellent safety record, few side-effects, and works well for all age groups. CES users sometimes have temporary headaches, lightheadedness, skin irritation from electrodes and rare paradoxical reactions (such as excitement, anxiety, sleep problems, or increases in pre-existing depression). Pregnant or lactating women, people with implanted bioelectrical devices, or those taking supplements or medications affecting the brain or vascular system should first consult with a physician. [24] Of 17 follow-up studies conducted up to two years after treatment, none showed negative effects. [25] Very few major short or long-term problems have therefore been found, and several of the devices carry FDA approval. [26]

Implications for Use

CES has been around for many years, yet its use in the U.S. remains little known. First of all, new therapies must prove efficacy to gain recognition. [27] Additionally, medical school training is non-existent, postgraduate continuing education offerings are scarce, and device makers lack marketing resources. [28] Given that mainstream providers and the public seem mostly unaware of the treatment, alternative providers may be prescribing it most. Among the few who do know about CES, opinions vary.

According to Dr. Daniel Kirsch, an authority on electromedicine and Chairman of Electromedical Products International, research shows CES to be safe, having good results for a range of brain based disorders. He believes the evidence supports use as a first line treatment for issues it effectively treats. [29]

Upon their review, insurer Aetna however, found that CES remains “experimental and investigational” for major depression, other psychiatric disorders, and for “neuropsychological indications (alcoholism, chemical dependency, dementia, depression, headache)…” They say that the evidence is encouraging, yet the issue needs more study. [30]

According to distributor Elixa Peak Performance, CES works best as a treatment (not a cure) for the anxiety, insomnia and depression that comes as a byproduct of stress. But the web site also suggests that it can treat a number of other stress related disorders as well as boost IQ and peak performance. [31]

In contrast, physician Dr. Stephen Barret of Quackwatch takes issue with those who claim benefits beyond approved uses or distributors who sell devices with commercial nutritional programs. He does concede that CES has shown effectiveness for anxiety and possible other uses. But he then points out that physicians, naturopaths or chiropractors (who prescribe CES most) might not be qualified to diagnose and treat neuropsychological problems. He further states that it’s better to get to the root of a problem than only treat symptoms. [32]

Writing on behalf of the Houston VA Pain Management Program, psychologists Dr. Gabriel Tan and Dr. Julie Alvarez argue for integrating CES and self hypnosis into multidisciplinary pain treatment programs. Clinic patients usually have intense chronic pain, not helped by analgesics; additionally, they often travel long distances for treatment, having limited means, and social problems. Seeing pain mainly as a physical problem and lacking resources for long treatments, patients often want tangible, fast results. CES and self hypnosis combined therefore meet the need, as they take little time and provide quick results. After getting some measure of relief, patients are often more willing to accept additional psychological help as a part of their treatment plan. [33]

Physician advocates Dr. Marshall F. Gilula and Dr. Paul Barach (in an editorial published by Southern Medical Journal) assert that the device can be a valuable treatment for the approved uses of anxiety, depression, and insomnia. While physicians usually treat those problems with psychoactive drugs, they point out that the medications often pose safety concerns; that is, they have potential for side-effects or dependency. [34] (FDA warnings for selective serotonin reuptake inhibitors used for depression, serve as a prime example.) [35] Like psychoactive drugs, CES does require ongoing medical supervision, but it doesn’t have the same potential for problems. Ultimately, they maintain that CES is of great value as a safe, non-drug alternative which can reduce or sometimes even replace medication use. They say that while CES is not a miracle cure, it is at least worthy of consideration. [36]

References

1. Kirsch DL, Smith RB. Cranial electrotherapy stimulation for anxiety, depression, insomnia, cognitive dysfunction, and pain: a review and meta-analysis. In: Rosch, PJ, Markov, MS, eds. Bioelectric Medicine. Mineral Wells, TX: Marcel Dekker, Inc.; 2004: 3-27. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

2. Smith RB. Scientific electromedicine. Positive Health. September 2003: 8.

3. Kirsch DL. A practical protocol for electromedical treatment of pain: cranial electrotherapy stimulation. In: Kirsch, DL, ed. 6th ed. Pain Management: A Practical
Guide for Clinicians. Boca Raton, FL: Greenwood Press; 2002: 1-6. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

4. Smith RB. Scientific electromedicine. Positive Health. September 2003: 8.

5. Kirsch DL. A practical protocol for electromedical treatment of pain: cranial electrotherapy stimulation. In: Kirsch, DL, ed. 6th ed. Pain Management: A Practical
Guide for Clinicians. Boca Raton, FL: Greenwood Press; 2002: 1-6. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

6. Gilula M, Barach P. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. Southern Medical Journal. 2004; 12:1269-1270.

7. Kirsch DL, Giordano, J. Cranialelectrotherapy. Natural Medicine. 2006; 23:118-120. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME. Accessed December 6, 2006.

8. Kirsch, DL. A practical protocol for electromedical treatment of pain: cranial electrotherapy stimulation. In: Kirsch, DL, ed. 6th ed. Pain Management: A Practical
Guide for Clinicians. Boca Raton, FL: Greenwood Press; 2002: 1-6. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

9. Kirsch, DL. A practical protocol for electromedical treatment of pain: cranial electrotherapy stimulation. In: Kirsch, DL, ed. 6th ed. Pain Management: A Practical
Guide for Clinicians. Boca Raton, FL: Greenwood Press; 2002: 1-6. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

10. Klawansky S, Yeung A, Berkey C, Shah N, Phan H, Chalmers, TC. Meta-analysis of Randomized controlled trial of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. Journal of Nervous and Mental Diseases. 1995; 7:478-484.

11. Ferjallah MB, Francis X, Barr RE. Potential and current density distributions of cranial electrotherapy stimulation (CES) in a four-concentric spheres model. IEEE Transactions on Biomedical Engineering. 1996; 939-943.

12. Schroeder M, Barr R. Quantitative analysis of the electroencephalogram during cranial electrotherapy stimulation. Clinical Neurophysiology: Official Journal of the International Federation of Clinical Neurophysiology. 2001; 11:2075-2083.

13. Giordano, J. How alpha-stim cranial electrothrerapy stimulation (CES) works.
Alpha – Stim Technology Web site. Available at: http://alphastim.com/Information/Technology/Giordano/how_ces_ works.html.
Accessed December 18, 2006.

14. Neuroscience for Kids. The autonomic nervous system. Neuroscience for Kids Web site. Available at: http://faculty.washington.edu.chudler/auto.html. Accessed December 17, 2006.

15. Giordano, J. How alpha-stim cranial electrothrerapy stimulation (CES) works.
Alpha – Stim Technology Web site. Available at: http://alphastim.com/Information/Technology/Giordano/how_ces_ works.html.
Accessed December 18, 2006.

16. Kirsch DL, Smith RB. Cranial electrotherapy stimulation for anxiety, depression, insomnia, cognitive dysfunction, and pain: a review and meta-analysis. In: Rosch, PJ, Markov, MS, eds. Bioelectric Medicine. Mineral Wells, TX: Marcel Dekker, Inc.; 2004: 3-27. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

17. Klawansky S, Yeung A, Berkey C, Shah N, Phan H, Chalmers TC. Meta-analysis of Randomized controlled trial of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. Journal of Nervous and Mental Diseases. 1995; 7:478-484.

18. Gilula M, Barach P. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. Southern Medical Journal. 2004; 12:1269-1270.

19. Gilula M, Barach P. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. Southern Medical Journal. 2004; 12:1269-1270.

20. Barret R. “Be wary of nutripax and the nutripax network”. Quackwatch Web site. Available at: http://www.quackwatch.org/01QuackeryRelatedTopics/ces.html.
Accessed November 21, 2006.

21. Klawansky S, Yeung A, Berkey C, Shah N, Phan H, Chalmers, TC. Meta-analysis of Randomized controlled trial of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. Journal of Nervous and Mental Diseases. 1995; 7:478-484.

22. Kirsch DL. A Practical protocol for electromedical treatment of pain: cranial electrotherapy stimulation. In: Kirsch, DL, ed. 6th ed. Pain Management: A Practical Guide for Clinicians. Boca Raton, FL: Greenwood Press; 2002: 1-6. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

23. Klawansky S, Yeung A, Berkey C, Shah N, Phan H, Chalmers, TC. Meta-analysis of Randomized controlled trial of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. Journal of Nervous and Mental Diseases. 1995; 7:478-484.

24. Elixa Peak Being. Cranial electrical stimulation (CES) for neurotransmitter balancing, mood control, IQ gains, sleep, exploration of altered states, peak performance, and much more. Elixa Peak Being Web site. Available at: http://www.elixa.com/estim/CES.htm
Accessed November 21, 2006.

25. Kirsch DL. A Practical protocol for electromedical treatment of pain: cranial electrotherapy stimulation. In: Kirsch, DL, ed. 6th ed. Pain Management: A Practical Guide for Clinicians. Boca Raton, FL: Greenwood Press; 2002: 1-6. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

26. Kirsch DL, Giordano, J. Cranialelectrotherapy. Natural Medicine. 2006; 23:118-120. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME. Accessed December 6, 2006.

27. Collins WG. Book review: the science behind cranial electrotherapy stimulation. NeuroRehabilitation. 2000; 2:123.

28. Kirsch DL, Giordano J. Cranialelectrotherapy. Natural Medicine. 2006; 23:118-120. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME. Accessed December 6, 2006.

29. Kirsch DL, Smith RB. Cranial electrotherapy stimulation for anxiety, depression, insomnia, cognitive dysfunction, and pain: a review and meta-analysis. In: Rosch, PJ, Markov, MS, eds. Bioelectric Medicine. Mineral Wells, TX: Marcel Dekker, Inc.; 2004: 3-27. Available at: http://alphastim.com/Information/Technology/Protocol/Introduction_A/MET/Survey/ME.
Accessed December 6, 2006.

30. Aetna clinical policy bulletin. Transcranial magnetic stimulation and cranial electrical stimulation. August 29, 2006. Aetna Web site. Available at: http://www.aetna.com/cpb/data/CPBA0469.html. Accessed December 16, 2006.

31. Elixa Peak Being. Cranial electrical stimulation (CES) for neurotransmitter balancing, mood control, IQ gains, sleep, exploration of altered states, peak performance, and much more. Elixa Peak Being Web site. Available at: http://www.elixa.com/estim/CES.htm
Accessed November 21, 2006.

32. Barret S. “Be wary of nutripax and the nutripax network”. Quackwatch Web site. Available at: http://www.quackwatch.org/01QuackeryRelatedTopics/ces.html.
Accessed November 21, 2006.

33. Tan G, Alvaraz JA, Jensen M. Complementary and alternative medicine approaches to pain management. Journal of Clinical Psychology. 2006; 11:1419-1431.

34. Gilula M, Barach P. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. Southern Medical Journal. 2004; 12:1269-1270.

35. FDA: U.S. index to drug specific information. U.S. Food and Drug Administration – Center for Drug Evaluation and Research Web site. November 20, 2006. Available at: http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm. Accessed November 22, 2006.

36. Gilula M, Barach P. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. Southern Medical Journal. 2004; 12:1269-1270.

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