Cranial electrical stimulation

Editor(s)-in-Chief: C. Michael Gibson, M.S.,M.D. [mailto:mgibson@perfuse.org] Phone:617-632-7753; Dr. Stephen J. Press [mailto:drsjp@drpress.com]

Overview
Cranial Electrical Stimulation (CES) is a treatment for anxiety, depression,  Cognitive disabilities, diabetic neuropathy, drug addiction, fibromyalgia, insomnia, pain,  and stress which utilizes small pulses of electric current (mA) across a patient's head. CES is widely regarded as safe and effective alternative treatment modality to pharmacotherapy.

Because of an early focus upon sleeping disorders, CES was originally known as electrosleep therapy. CES is sometimes written Cranial-Electro Stimulation, NeuroElectric Therapy, and Transcranial Electrotherapy and Neurotransmitter Modulator.

History
"Electrotherapy" has been in use for more than 2000 years, as shown by engravings on the walls of Egyptian tombs showing the use of the Nile catfish (Malopteurus electricus) for treatment of various conditions. The clinical literature of the early Roman era physician, when Aristotle and Plato reference Scribonius Largus's, writings 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.

Low intensity electrical stimulation is believed to have originated in the studies of galvanic currents in humans and animals as conducted by Giovanni Aldini, who in 1801 treated a farmer for "Melancholy" and was reputed to have cured him ; 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.

Modern research into low intensity electrical stimulation of the brain was begun by Leduc and Rouxeau in France (1902). In 1949, Giljarowski, V.A., in St. Petersburg, USSR expanded research of CES to include the treatment of anxiety as well as sleeping disorders.

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. In 1976, Dr. Margaret Patterson described using CES to treat drug addiction, and marketed a device under the name "NeuroElectric Therapy" and NET.

About the same time, Saul Liss,BSEE,PhD, working in Paterson, NJ developed the Liss Pain Suppressor, using a 15khz carrier wave, a 15hz, "active wave" and a third harmonic 500hz "modifier wave" signal with low voltage, which he theorized used the skull as a dialectric to provide a "triggering energy" to facilitate the firing of a synapse, sending a signal through the hypothalamus. He obtained an FDA approval for treatment of depression. It was soon clear that there was an increase in serotonin with concomitant decrease in tryptophan caused by his device. He ultimately obtained approval for treatment of pain as well. After dissolving a partnership with "Pain Suppression Labs", he recommenced marketing the instrument alone under the name "Medi-Consultants". After his passing in 2006, his estate sold the rights to his instrument to Fisher-Wallace Laboratories in NY.

Effectiveness
At present, there are over 125 research studies on CES in humans and 29 experimental animal studies. The overwhelming majority of the scientific research is extremely positive. No significant lasting side effects have been reported.

For Pain
1977- Looking at a pool of 220 patients at the University of Miami, School of Medicine, Dept of Neurology, Markovich, reported that "ten minutes with the (Liss) Pain Supressor  (CES device), was enough to produce considerable improvement that, in the majority of cases, not only reduces the pain, but produces a marked and persistent relaxing effect in the muscles. 1993 -  Ten patients were studied, who suffered from chronic neck, shoulder arm pain, and were treated with the Liss bipolar body stimulator  (a model variant of the Liss Cranial stimulator), and 8 of 10 showed a "substantial reduction of pain", as evidenced by scores on the VAS. The benefit was maintained throughout the month of therapy and their "reliance on medication was reduced". 1994 - At the VIth Int'l Congress on Stress  in Montreux, Switzerland, Morrison and Liss presented a retrospective of the studies performed with the Liss (CCES) Stimulator, reporting benefits for patients with chronic pain, headaches, fibromyalgia, etc.

Diabetic Neuropathy
C. Norman Shealy, et al, showed  improvement in diabetic neuropathy in 17 of 21 patients over a 12 week treatment regimen, using the GigaTENS unit to treat specific acupuncture points, and progesterone cream.

For Headache
1984 - Solomon, et al, in a study at Montefiore Medical Center, of 62 (minus 4 eliminated for various reason) patients with migraine, muscle contraction headache, or both, using the Liss Stimulator, found that 55% noticed improvement with perceived stim, 28% with subliminal stim., and only 18% with placebo. Romano evaluated 100 patients with Fibromyalgia syndrome headaches, and found that after therapy, the vast majority of his patients reported significant benefit from the CES.

Fibromyalgia
In a study of 60 patients with fibromyalgia, it was found that "Treated patients showed a 28% improvement in tender point scores, and a 27% improvement in self-rated scores of general pain level. The number of subjects rating their quality of sleep as poor dropped from 60% at the beginning of the study to 5%."

For Depression, Anxiety and Insomnia
1989 - Shealy, et al, using the Liss device, measured baseline, 8AM levels of beta-endorphin(BE), Serotonin (ST), Norepinephrine (NE), and Cholinesterase (CHE), in 14 normal individuals. They then measured these levels in 11 severely depressed patients, and 23 chronic pain patients. Incidental to the study was their finding that the chemical profiles they developed showed the relationship of chronic pain to depression. The overall findings showed significant benefits from CES (Liss Stimulator) to both the depressed patients and those with chronic pain. 1995 - Harvard University School of Public Health, Department of Health Policy and Management found: "The meta-analysis of anxiety showed CES to be significantly more effective than sham (P<.05)." 2000 - In a larger study involving 351 patients with specific depression, Shealy, et al found that photostimulation, education, and vibratory music, was effective therapy in 58% of patients, but when combined with the Liss stimulator, the effectiveness increased to 85%, and 70% of those remained improved after 3 months with no further intervention. 2005 - A meta-analysis has been performed investigating the effectiveness of CES in the treatment of anxiety, depression, insomnia and the retention rates of newly abstinent substance abuse individuals in community-based residential treatment.

For Cognitive disabilities
1999 - A Study preformed by Susan Southworth, demonstrated a significant improvement in attention and concentration, as measured by a Conner's Continuous Performance Test (CPT).

For Cerebral palsy
The following studies (inter alia) are presented for the Liss stimulator:

1980's - Groundbreaking research in therapy for Cerebral palsy children and others with related disabilities was done by Malden and later by Renee Okoye. Using the Liss CES device.Together and individually several papers were published demonstrating significant benefits in terms of concentration and "Sensory integration" in this population. 1988 - Michael Logan, received the prestigious Richmond Prize from the American Academy for Cerebral Palsy and Developmental Neurology, for his work using the Liss stimulator to treat CP children. His research, which was double blinded and placebo controlled, showed "impressive gains in work performance, 19.9% increase in mechanical efficiency and 43% in workload output, while the placebo group declined".

1993 - Childs published a case report of Liss-CES use in a 25 yr old female, with post anoxic spasticity, in which he reported with sub-occipital placement of the electrodes, that this patient's tonicity was significantly improved along with other benefits, e.g., reduction in her "screaming", and somnolence during treatments when she was normally highly agitated. 1998 - Alon, et al, of the Univ of Maryland School of Medicine, saw 7 CP children and, in a double blind, placebo controlled study using the Liss  (Medi-Consultants) stimulator, demonstrated significant improvement in mean popliteal angle, and motor performance.

Immune system and Anti-Aging Medicine
1995 - Shealy, et al, reported significant increases in DHEA levels from baseline, in 8 patients, after 12 weeks of application of the Liss  Stimulator  for 5 minutes to 12 traditional acupuncture points, "including those for adrenal, thyroid, and 'Tchong Mo' sites"

Addiction
1984- Published clinical results showed that by coupling NeuroElectric Therapy with approximately two weeks of a residential rehabilitation program, participants being treated with such a protocol exhibited a dropout rate of less than 2% and experienced long-term drug abstinence rates of approximately 80%, based upon a follow-up study that determined the sampled participants’ abstinence status anywhere from 1 - 8 years after their initial treatment (n=186). This is compared with about a 3% long-term average abstinence rate for people who are treated using traditional methods. A specific form of CES, can be used to ameliorate the effects of acute and chronic withdrawal from addictive substances. CES has been in clinical use in the USA since 1963 and in Europe since 1953, and is recognized by the FDA for the treatment of depression, anxiety and insomnia.

Regulation
In the United States, CES equipment must be prescribed by a licensed independent medical provider, 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.

The effectiveness and safety of CES was never fully evaluated by the FDA, as is done with new medical devices, as the technology was "grandfathered" in with the existing treatment label. Thus new CES devices can receive FDA approval without submitting any clinical data by following a 510k approval mechanism.

Proposed mechanism of action
The exact mechanism of action of CES remains unclear but it is increasingly being viewed as an adaptogen in that CES reduces stress that underpins many emotional disorders. 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.

It has been proposed 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. CES treatment promotes an increase in endorphin, though scientists remain unsure why this occurs.. 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.

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. When CES is effective, users are in an "alert, yet relaxed" state, characterized by alpha brain waves.

Similar Devices
Electrical devices are not as commonly used in psychiatry as medication, in part due to the stigma of electrical devices for use on the brain (which many relate to electroconvulsive therapy). Other electrical devices that claim to treat psychological disorders are emerging, including devices for vagus nerve stimulation.

Podcast Discussion on CES uses
Youtube Playlist of Lecture on CES (1/20/2011) NYC