Post Published on July 2, 2013.
Last Updated on April 29, 2016 by davemackey.

[NOTE: This post is still in process, but I’ve been fascinated by this treatment methodology, so I’ve done quite a bit more development of it from the original article and while I will continue to revise it, I think it is fairly sufficient. Next step is for me to get my hands on one of these devices and try it for myself…]

Introduction

I’m frustrated. It is 4:05 am and I haven’t been asleep for more than 10-15 minutes at a time yet. Bouts of insomnia like this are an occasional and frustrating occurrence for me. Usually I can’t fall asleep until 6 am – and then what? Sleep through the next day? Gahh!

I decided to Google “what to do the day after insomnia” and came across an ad for a Cranial Electrotherapy Stimulation¹Outside the United States it is oftentimes referred to as “electrosleep.” In the past was known by terms including “transcranial electrotherapy (TCET)” and “neuroelectric therapy (NET).” device. It allegedly works with insomnia, anxiety, depression, pain, etc. Sounds too good to be true right? Yeah, probably, but I figure I’ll do some research and share here what I find out…

Table of Contents

• Introduction
• General Claims / Specifications
• Products / Manufacturers
  • Electromedical Products / Alpha-Stim
  • Fisher Wallace Laboratories / Stimulator
  • Neuro-Fitness / CES Ultra.
  • Other Vendors.
• Similar / Related Treatments.
• Recommended Reading.
• Annotated Bibliography.

General Claims / Specifications

In this section I’ll discuss various claims that are generally made across device manufacturers and then look at some specific claims from various device manufacturers in separate sections below.

• The devices provide electrical stimulation to the brain in a similar way to Electro Convulsive Therapy (ECT).
• They are very safe and have been in use since the 1960’s.²Alpha-Stim claims “no serious adverse events reported” since launching the product in 1981.
• They are much more cost effective over time than antidepressant medications.
• Rare side effects are headache, dizzines, skin irritation.
• CES has never been documented causing a seizure.

Products / Manufacturers

Below you’ll find a list of products/manufacturers. The three main manufacturers appear to be Electromedical Products with Alpha-Stim, Fisher Wallace Laboratories with their Stimulator, and Neuro-Fitness’ CES Ultra. Other vendors – still present or defunct are listed below these companies.

Electromedical Products: Alpha-Stim

• Product introduced to the market in 1981.
• Company founded by Dr. Daniel L. Kirsch.
• Warranty: 5 Year Manufacturers Warranty.
• Current: 0-600 mA.
• Frequency: 0.5, 1.5, or 100 Hz w/constant 0.4 Hz.
• There Alpha-Stim M product is meant to treat pain, anxiety, insomnia, and depression – while the AID does not treat pain.
• Largest customers are the Department of Defense and Veterans Affairs.
• Advocates: Dr. Daniel L. Kirsch (President, American Institute of Stress)³He has numerous other credentials., Dr. Brian Earthman, Dr. Larry R. Price, Dr. Jeffrey A. Marksberry, Dr. William Wong, Dr. Regina McGlothlin, Dr. Norman L. Dykes, Dr. Harry Nakata, Dr. Richard H. Cox (Research Consultant, Duke University Medical Center; Associate Fellow, Georgetown University Medical Center), Dr. Margaret M. Waddington (neurologist), Dr. David J. Fair (Chaplain),

Fisher Wallace Laboratories: Fisher Wallace Stimulator

• Price: $495-$715.
• Returns: 60 Days (claim less than 10% return devices).
• Warranty: 5 Year Manufacturers Warranty.
• Can be used safely with any medication.
• Functions by stimulating the brain’s production of neurotransmitters (e.g. serotonin, beta-endorphin).
• Usually used 2x daily for twenty minutes.
• Symptom reduction occurs within 1-4 weeks.
• Based on acquired technology from Dr. Saul Liss, formerly known as “Liss Cranial Stimulator.”
• Offers the contact info. for a “licensed healthcare practitioner” who will provide “over-the-phone” authorization to appropriate individuals for $50.
• Advocates: Dr. Richard Brown (Professor of Psychiatry, Columbia University Medical Center), Dr. Andres San Martin (Professor of Psychiatry, Columbia University Medical Center), Dr. Karen Hopenwasser (Clinical Associate Professor of Psychiatry, Weill Cornell College of Medicine), Dr. Paul Fauteck (Psy.D.), Dr. Robert Cancro (Professor/Chairman, Department of Psychiatry, New York University School of Medicine)⁴Dr. Cancro has numerous other credentials., Dr. Stephen N. Xenakis, Dr. Ronald Podell, Dr. Kelly Brogan, Dr. Lauri Liskin (Clinical Assistan Professor of Psychiatry, Weill Cornell College of Medicine), Dr. Bruce Johnson (Staff Psychiatrist, Crozer Medical Center), Dr. Stephen J. Press, Dr. Sandlin Lowe (Faculty, New York University School of Medicine).

Neuro-Fitness: CES Ultra

• Price: $349.
• Returns: 30 Days Unconditional Money Back Guarantee.
• Warranty: 1 Year Parts/Labor.
• Advocates: Dr. Charles McCusker, Dr. Eric Braverman (Director, PATH Medical), Dr. Jonathan Douglas.

Other Vendors

The three vendors above appear to be the main competitors in this market. The companies below did / do sell CES devices, but when we are talking about electrifying one’s brain, I’m going to stick with the market leaders – especially when most of these companies seem to be defunct.

• Orion Medical Group. Magnetic Black Belt – Couldn’t find much info. on this company.
• Health Directions. HealthPax – Difficulty finding info. related to this product, though it appears to still be sold. Wondering if it is related to the NutriPax that was scathed by QuackWatch?
• Neurotone Systems. Neurotone – Not much info. available, found a company called Neurotone, but doesn’t sell CES devices, unsure if related.
• Kalaco Scientific, Inc. Transcranial Electrotherapy Stimulator-A – Little info. available, it appears a business with this name experienced legal troubles and is probably out of business.

Similar / Related Treatments

• Transcranial Magnetic Stimulation (TMS).
  • Fisher Wallace suggests that TMS treatments cost around $8k-$12k and aren’t covered by insurance.
  • Fisher Wallace states that TMS has only been cleared by FDA for treating Major Depressive Disorder, while their device is cleared for depression, anxiety, insomnia, and pain.
  • TMS is performed at a doctor’s office with expensive equipment.
• Electroconvulsive Therapy (ECT).
  • Has a very bad reputation due to its portrayal in movies and its historical abuses within psychiatry.
  • Delivers 800-1000+ mA of electricity, compared to 1-4 mA for Fisher Wallace.
  • Cost is significant, though can be reimbursed (sometimes) by insurance.
• Transcranial Direct Current Stimulation (tDCS).
  • Approved by FDA for other purposes (“lontophoresis”) not for depression, anxiety, etc.

Recommended Reading

• Daniel L. Kirsch. The Science Behind Cranial Electrotherapy Stimulation. Edmonton, Alberta, Canada: Medical Scope Publishing Corporation, 2002.
• Ray B. Smith. Cranial Electrotherapy Stimulation: Its First Fifty Years, Plus Three: A Monograph. Washington, DC: 2006.

Annotated Bibliography

[Note: I’ve barely touched the available research, Google Scholar is returning 2,190 results relating to the query “cranial electrotherapy stimulation]

• Cranial Electrotherapy Stimulation Presentation to FDA Neurology Panel, February, 2012. – This appears to have been made and presented by someone advocating for CES. February, 2012.
• JD Feusner, S Madsen, TD Moody, C Bohon, E Hembacher, SY Bookheimer, A Bystritsky. “Effects of Cranial Electrotheraphy Stimulation on Resting State Brain Activity.” Brain Behavior Journal, 2012 May, 2(3):211-20. – Indicates brain activity is decreased by utilization of CES devices.
• BlueCross BlueShield of Minnesota. Medical and Behavioral Health Policy Manual. Policy X-32, Effective Date: 6/26/13. “Cranial Electrotherapy Stimulation.” – States that CES is similar to Transcutaneous Electrical Stimulators “but produce different wave forms at a much lower level.” Does not appear opposed to use of CES, but considers results too tentative.
• MJ Schroeder, RE Barr. “Quantitative Analsysi of the Electroencephalogram During Cranial Electrotherapy Stimulation.” Clinical Neurophysiology Journal, 2001 Nov.; 112(110):2075-83. – Indicates that there is a reduction in brain activity, most benefit is seen with 100 Hz as opposed to 0.5 Hz.
• United States Army Institute of Surgical Research. “Cranial Electrotherapy Stimulation in Burned Patients (CES).” ClinicalTrials.Gov. – The results are not easily decipherable, but if I understand it correctly it seems that overall, CES had a negative effect on test subjects.⁵I say this very tentatively, I really could be reading these results backwards. For PTSD for example, the higher the score the more severe the PTSD, those receiving treatment ended with 55.5 while those receiving placebo ended with 44.7. For depression, ending was 36.3 versus 21.7. I did not review all results. Perhaps someone would be willing to interrupt these results?
• Stephen Barrett. “Dubious Claims Made for NutriPax and Cranial Electrotherapy Stimulation.” Quackwatch. – Seems to be more concerned with the specific manner in which NutriPax was combining CES with nutritional supplementation than necessarily with CES generally.
• Eileen Jones. “Cranial Electrotherapy Stimulation: A Non-Drug Neuromedical Treatment.” BrainBlogger, 12/26/06. – An older article but fairly extensive and with significant footnotes/sources.
• Gabriel Tan, Diana H. Rintala, John I. Thornby, June Yang, Walter Wade, Christine Vasilev, Michael E. DeBakey. “Using Cranial Electrotherapy Stimulation to Treat Pain Associated With Spinal Cord Injury.” Journal of Rehabilitation Research & Development, Vol. 43, No. 4, pp. 461-474, July/August 2006. – Found CES to provide a significant reduction in symptoms.
• RC Cork, PB Wood, N Ming, C Shepherd, J Eddy, L Price. “The Effect of Cranial Electrotherapy Stimulation (CES) on Pain Associated with Fibromyalgia.” The Internet Journal of Anesthesiology, 2004, 8(2). – Several measures showed significant improvement in pain levels, but Oswestry score showed no significant effect.
• Daniel L. Kirsch, Francine Nichols. “Cranial Electrotherapy Stimulation for Treatment of Anxiety, Depression, and Insomnia.” Psychiatric Clinics of North America, Vol. 36, Issue 1, March 2013, pp. 169-176. – Written by individuals working for a CES manufacturer, found significant positive results.
• Alan S. Lichtbroun, Mei-Ming C. Raicer, Ray B. Smith. “The Treatment of Fibromyalgia with Clinical Electrotherapy Stimulation.” Journal of Clinical Rheumatology, April 2001, Vol. 7, Issue 2, pp. 72-78. – Shows significant success in improving sleep and decreasing pain.
• Rucgard Scgnuttm Tginas Caoim EMn Boyd. “Cranial Electrotherapy Stimulation as a Treatment for Anxiety in Chemically Dependent Persons.” Alcoholism: Clinical and Experimental Research, Vol. 10, Issue 2, pp. 158-160, March 1986. – Found significant improvement in anxiety amongst test subjects.
• Alexander Bystritsky, Lauren Kerwin, Jamie Feusner. “A Pilot Study of Cranial Electrotherapy Stimulation for Generalized Anxiety Disorder.” Journal of Clinical Psychiatry, 69:3, March 2008. – Reports significant positive improvement in individuals with GAD using CES.
  • Abstract also available on PubMed.
• Marshall F. Gilula, Daniel L. Kirsch. “Cranial Electrotherapy Stimulation Review: A Safer Alternative to Psychopharmaceuticals in the Treatment of Depression.” Journal of Neurotherapy, Vol. 9, Issue 2, 2005, pp. 7-26. – Abstract states, “The results suggest there is sufficient data to show that CES technology has equal or greater efficacy for the treatment of depression compared to antidepressant medications, with fewer side effects.”
• SS Koppolu, G Kazariants, M Varvara, D McClure, Z Yaseen, AMR Lee, I Galynker. “A Single Blind, Randomized, Sham Controlled Study of Cranial Electrical Stimulation in Bipolar II Disorder.” The Family Center for Bipolar, Beth Israel University. – After two weeks, patients showed significant improvement on the Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory (BDI), and Quality of Life Satisfaction and Enjoyment Questionnaire (Q-LES-Q). Research was funded by Fisher Wallace, who manufactures CES devices.
• Marshall F. Gilula, Paul R. Barach. “Cranial Electrotherapy Stimulation: A Safe Neuromedical Treatment for Anxiety, Depression, or Insomnia.” Southern Medical Journal, 2004, Vol. 97(12).
• Mostafar Amr, Mahmoud El-Wasify, Ahmed Elmaadawi, R. Jeannie Roberts, Rif S. El-Mallakh. “Cranial Electrotherapy Stimulation for the Treatment of Chronically Symptomatic Bipolar Patients.” Journal of ECT, June 2013, Vol. 29, Issue 2. – Symptoms continue but experience modest improvement.
• Ingrid Moreno-Duarte, Leslie Morse, Mahtab Alam, Marom Bikson, Ross Zafonte, Felipe Fregni. “Targeted Therapies Using Electrical and Magnetical Neural Stimulation for the Treatment of Chronic Pain in Spinal Cord Injury.” NeuroImage, May 30, 2013 (Online, Uncorrected Proof). – Some studies show significant improvements, others not as much – article suggests need for better treatment methods to ensure optimal improvements.