Cranial Electrotherapy Stimulation (CES) is a neurotherapy that applies extremely small levels of pulsed electrical stimulation across the head for therapeutic treatment of anxiety, depression, insomnia and chronic pain.
CES is approved in the United States by the Federal Drug Administration (FDA) within a category for medical devices (Class 11A. Type BF) using microcurrent levels of electrical stimulation (typically less than 1 milliampere) across the head via transcutaneous electrodes for the treatment of anxiety, depression, and insomnia.
CES differs from transcutaneous electrical nerve stimulation (TENS), commonly used in physical therapy, which is a low frequency, high-current (hundreds of millamperes) modality used to reduce nerve pain by closing the spinal "pain gate".
CES was originally developed in the Soviet Union in 1949, its primary focus being the treatment of sleep disorders— hence, its original designation as “electrosleep”— which became quite popular in Europe in the 1960’s. However, the treatment of insomnia was soon overshadowed by psychiatric applications for anxiety and depression.
The treatment of anxiety and depression with CES began in the United States in the early 1960s and it is currently rountinely prescribed by a few thousand physicians and mental health practitioners in the US and Canada for a variety of brain-related psychiatric conditions, although it has yet to achieve full acceptance as a mainstream treatment. This is possibly because sufficient information has not been made available to the majority of medical practitioners regarding the safety and efficacy of CES.
While there are over 160 published scientific research studies generally supporting the safety and efficacy of CES in the treatment of psychological disorders— particularly anxiety, depression and insomnia— the majority of physicians in general medical practice are simply unaware of them. Unlike pharmaceuticals, there is no large industry promoting CES to physicians.
In general, commercially-available CES devices are sold to the public as a means to enhance relaxation and relieve stress, and the majority of these devices are geared toward increasing brain electrical activity in the alpha band (8-12 Hz) of the EEG but some devices may be adjustable to entrain any desired frequency band, including Delta (1-4 Hz) for deep sleep and Beta (15-20 Hz) for increased mental energy and focus.
It is estimated that nearly 100,000 CES devices are currently in use world-wide.
Mind Alive Inc. in Edmonton manufactures and sells a number of different CES devices. GOTO: www.mindalive.com
How does CES work?
CES is a relatively simple treatment employing a small, battery-powered device that is similar in size and appearance to the transcutaneous electrical nerve stimulators (TENS) devices commonly used in physical therapy for pain relief, but CES devices produce very different waveforms at a much lower current level. The CES device sends pulses of very low amperage (i.e., less than 1.0 milliampere) electricity through thin wires attached to electrodes clipped to the ear lobes or stuck to the skin over the mastoid (i.e., the bony prominences just behind each ear). The frequency of the electrical pulses can be adjusted— usually from 0.5 Hz to 100 Hz— depending on the treatment effect desired.
EEG monitoring during CES has shown that stimulating the brain at 0.5 Hz reduces the median frequency of the Alpha band and results in a relaxed but alert state. Stimulation at 100 Hz also reduces the Alpha band median frequency as well as reducing higher frequency Beta band power.
As with most medications for psychological problems, the actual mechanism by which CES works is not yet fully understood. Research to date suggests a number of possible mechanisms of action, including direct action on the brain at the level of the limbic system, the reticular activating system and the hypothalamus, increased release of various neurotransmitters and endorphins in the brain, increased parasympathetic nervous system dominance, and changes in blood flow and the electrical rhythms (EEG) of the brain. Some researchers have reported rapid increases in serotonin, a brain neurotransmitter associated with relaxation and calmness, and decreases in cortisol, one of the primary stress-related hormones in patients treated with CES. As well, CES is known to increase levels of the brain neurotransmitters norepinephrine and dopamine, both associated with alertness and feelings of pleasure. Interestingly, serotonin, norepinephrine and dopamine are the same neurotransmitters that most antidepressant medications attempt to effect.
What does CES feel like?
Applied to the ear lobes or to the mastoid process, just behind the ear, CES causes the patient to experience nothing more than a faint tingling sensation. As the treatment continues, most patients begin to feel less anxious, less distressed, and relaxed and, yet, more mentally alert and focused. Patients with positive outcomes generally sleep better and report improved focua and concentration, increased learning abilities, enhanced recall and a heightened state of well-being after only a few CES treatments. Most people can resume normal activities immediately after treatment. Some people may experience a euphoric feeling, or a state of deep relaxation that may temporarily and minimally impair their mental and/or physical abilities for the performance of potentially hazardous tasks, such as motor vehicle operation. In some cases, this may last up to several hours after treatment.
CAUTIONARY NOTE: Until you have experienced CES for yourself and are certain of how you will react to treatment, it is best that you arrange for someone else to drive you to and from your clinic appointment and not plan on returning immediately to work.
Most patients are left feeling relaxed and alert after a CES session— in what psychologists call an “alpha state”. This state differs from pharmaceutical treatments in that people report feeling that their bodies are lighter and more relaxed and their minds more alert and clear. The results tend to be cumulative and lasting.
Who Should Use CES?
CES should be considered as a first-line treatment for mild to moderate depression, anxiety, sleep onset insomnia, as well as headache and other types of pain conditions by individuals who are seeking an effective non-pharmacologic alternative. It should also be considered as an adjunctive and complementary treatment to more conventional pharmaceutical treatments for more severe depression and anxiety disorders. CES can be an important and efficacious complementary treatment for stress-related illnesses or problems where stress constitutes a prime symptom. CES has shown efficacy in normalizing central hemodynamics (systolic and diastolic blood pressure) in Stage 1 Hypertension. CES has shown mixed results in substance abuse treatment and recovery. CES has also shown some success in treating symptoms of fibromyalgia. In particular, CES treatment appears to increase Stage IV Delta deep sleep that is important for physical rejuvenation.
What are the adverse effects of CES?
From a broad reading of the published literature, CES has an unblemished record of safety, especially in comparison to more conventional pharmaceuticals used to treat similar conditions. It works equally well for both men and women and has been safely used with children as young as 3 years of age. There have been no reports of enduring or serious adverse effects or clear contraindications to CES treatment. That said, there are circumstances in which its safety has not been tested. Accordingly, CES should not be used without ongoing clinical supervision by persons suffering from severe depression or known to be epileptic, pregnant, or those using implanted electronic medical devices such as cardiac pacemakers or insulin pumps. Also, due to the relaxing effect of CES treatment, patients are cautioned in the use of hazardous machinery or driving following CES treatment.
Adverse effects as seen in approximately 5000 patients in controlled, open, uncontrolled conditions, and by physician survey and reasonably associated with the use of CES are... dizziness (0.13%), skin irritations/electrode rashes (0.11%), and headaches (0.20%). Prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last as long as a few hours or a day or so. Using CES immediately prior to going to sleep may cause difficulty sleeping due to increased alertness in some individuals. Paradoxical reactions such as hyperexcited states, increased anxiety, and sleep disturbance may occur early in treatment in some individuals but have always shown themselves to be transient or short-lasting. There have been isolated reports of CES lowering blood pressure.
CES treatment has not been reported to interact negatively with any medications but patients taking psychoactive medications or herbals simultaneously with CES should only do so under the supervision of a qualified health practitioner. Experience with CES and psychoactive and vascular medications to date points to a general effect of potentiation of the medication often resulting in the need for less medication over the course of CES treatment.
What is the evidence for the effectiveness of CES?
Research studies of CES that been published to date reveal significant changes associated with relaxation responses such as reduced muscle tension, positive changes in brain wave activity, increased vasodilation, reductions in gastric acid output, and reductions in blood pressure, pulse, respiration, and heart rate. CES research has also shown significant reductions in clinical depression (Gilula & Kirsch, 2005), anxiety (Klawansky, et al., 1995) and fibromyalgia symptoms (Lichtbroun, et al., 2001).
More than 25 clinical research studies examining the efficacy of CES for the treatment of depression have been published, with over 80% of these studies reporting significant clinical improvements in the symptoms of depression (Gilula & Kirsch, 2005).
A recent meta-analysis of 22 placebo-controlled CES research studies involving a total of 1075 patients found that the average treatment effect beyond that attributable to placebo was 57% (Gilula & Kirsch, 2005). This compares very favourably with the often claimed 40-60% average treatment effects beyond placebo for antidepressant medications.
CES has also been shown to improve sleep and memory consolidation during sleep (Born, et al. 2006; published in Nature).
What results can I expect?
In the treatment of anxiety or depressed mood, most patients undergo CES treatment for about 30-45 minutes, 2-3 times a week for a period of 3-5 weeks, followed by another couple of weeks of treatments once a week or every second week as necessary.
Individual results vary and depend on a variety of factors, including the severity and chronicity of the condition, what medication has been prescribed (if any), the presence of other concurrent medical factors and, ultimately, the patient’s level of motivation. Some disorders can be successfully treated in 8-15 sessions; others require more extensive treatment.
For some patients there is extra benefit to combining CES with other forms of neurotherapy such as Audio Visual Entrainment (AVE) therapy or certain biofeedback therapies such as Heart Rate Variability (HRV) biofeedback.
Mind Alive Inc. in Edmonton manufactures a device that combines Audio Visual Entrainment (AVE) with CES.
Selected Bibliography
Klawansky, S., Yeung, A., Berkey, C., Shah, N., et al. (1995). Meta-analysis of Randomized Controlled Trials of Cranial Electrostimulation: Efficacy in the Treatment of Selected Psychological and Physiological Conditions. Journal of Nervous and Mental Diseases, 183(7):478-484.
Schroeder, M.J., Barr, R.E. (2001). Quantitative Analysis of Electroencephalogram During Cranial Electrotherapy Stimulation. Clinical Neurophysiology, 112(11):2075-2083.
Gilula, M.F. (2004). Cranial Electrotherapy Stimulation: A Safe Neuromedical Treatment for Anxiety, Depression and Insomnia. (Letters to the Editor). Southern Medical Journal, 97(12):1269.
Gilula, M.F., Kirsch, D.L. (2005). Cranial Electrotherapy Stimulation Review: A Safer Alternative to Pharmaceuticals in the Treatment of Depression. Journal of Neurotherapy, 9(2):7-26.
Gilula, M.F. (2007). Cranial Electrotherapy Stimulation and Fibromyalgia. Expert Reviews of Medical Devices, 4(4):489-495.
Kirsch, D.L., Gilula, M.F. (2007). Cranial electrotherapy Stimulation in the Treatment of Insomnia: A Review and Meta-Analysis. Practical Pain Management, October 2007, pp. 28-37.
Smith. R. (2007). Cranial Electrotherapy Stimulation - Its First Fifty Years, Plus Three. A Monograph.
