Allen J. Johnson, ND - CES

CES (cranial electrotherapy stimulation) is a simple non-invasive approach to stress management. It employs mild battery-powered electrical stimulation through clip-on electrodes attached to the earlobes or pre-gelled electrodes placed behind the ears. Current flow is limited so that the most a user will experience during the process is a slight tingling sensation. CES gently adds energy back to all parts of the brain, helping return you to the optimum state in effect before stressors were activated.

CES's most immediate impact is reduction of anxiety. For most, it is experienced in the course of treatment; for others, hours, or several days after. CES leaves you feeling both relaxed and alert. The effect differs from pharmaceutical treatments in that people report feeling their bodies as lighter and more relaxed and their mind more alert and clear. Results are cumulative and lasting.

Cranial Electrotherapy Stimulation or CES:

CES provides small pulses of electric current across the head for the FDA recognized treatment of anxiety, insomnia and depression. The current is up to but usually no more than 1.5 Milliamperes powered by a nine-volt battery.

What it Does:

CES stimulates each neuron to increase the manufacture and use of its neurotransmitter until all of them achieve mutual inhibition of each other's further production. This leaves the patient in the pre stress level of homeostasis.

Pulse Characteristics:

The CES devices used in most U.S. studies pulse at 0.5 Hz, or 100 Hz, with either a sinusoidal or a modified square wave. Current intensity is set below sensation threshold, usually around 100 microamperes, and the device is on a 20% to 50% duty cycle, with a peak voltage of 11 to 14 volts.

Change in EEG:

EEGs of pain and high stress patients are typically somewhat erratic, with a large root mean square deviation around their mean spikes. CES smoothes this out, reducing the dramatic fluctuations around the mean, similar to that of pain free, and low stressed persons

History:

CES has been in the U.S. since the late 1960s, known at first as Electrosleep; the name was changed by the FDA to Cranial Electrotherapy Stimulation, in 1978. FDA permits its marketing in the U.S. for the treatment of anxiety, depression and insomnia

Research:

Presently there are more than 100 human and 20 animal studies appearing in the U.S. literature. At any given time, more than 5 additional open clinical, and double blind studies are underway in the U.S., Europe, and around the world. References are available by calling 800-488-8492.

Is CES Safe?

To date, more than 5,000 people have been involved in CES research, and no significant negative effects have been found in any of the participants. A few patients have reported a slight headache, which can be alleviated by turning down the intensity.

CES has an unblemished safety record. It is not harmful even when turned to maximum intensity. It is not necessary to turn the unit up to the maximum for a therapeutic affect.

How does CES Affect Sleep?

Typically, sleep patterns begin to normalize within a day or two with less and shorter periods of awakening during the night, faster onset of sleep, and a greater feeling of being rested upon awaking in the morning.

Does CES work for Everyone?

Nothing works for everyone, but CES is effective for most people.

Why is CES important in treating chronic pain?

It has been theorized that CES is effective in pain treatment because it is known to relieve stress, and stress is known to be a strong correlate of the perception of pain in pain patients.

Recently, it has been shown that pain also frequently accompanies depression, which CES is known to treat very effectively. In one study more than 75% of patients being treated for depression reported experiencing chronic or recurring pain and 30% to 60% of pain patients also reported significant depression.

What immediate results should be expected?

Most people experience a positive response almost immediately and others after several days. The relaxed but alert state will usually remain for an average of 12 to 72 hours after the first few sessions.

How often do patients use CES and how long do the effects last?

Both of these are very individual. Some people will experience results very quickly and others will experience results in a day or two. After regular use, patients will usually use the unit every other day or even 2-3 times a week.

How long is the treatment and how long can I use it at one time?

This is also dependent on the patient. Some patients will use it for 30-60 minutes and others, such as those diagnosed with Fibromyalgia, may wear it for several hours at a time.

What CES units are the best?

The most significant research on CES is based on the traditional 100Hz configuration. There is also research on units with less than one hertz.

Is CES Approved by the FDA?

Unlike the process that a pharmaceutical company must go through for approval for a new drug,, a medical device manufacturer must go through an entirely different process unless it is a completely new device and in a new category. In that case, the device goes through the Pre-market Approval Process (PMA) including clinical trials, just like a pharmaceutical company does with a new drug.

If a similar device is already on the market (called a predicate device), a medical device manufacturer goes through a 510(k) process. In this process the FDA determines if the new device is substantially equivalent (SE) to the predicate device that is currently on the market.

This also means any studies and science that have been published apply to all devices in that same substantially equivalent category.

All CES devices on the market today have a 510(k) against the original Neurotone Device that was grand fathered when the Device Amendment was passed in 1976, because it was on the market before the law was passed. Therefore, they are all considered substantially equivalent (SE) by the FDA.

The FM 10/C is cleared by the FDA as both a TENS and a CES device. 510(k) # K090052