Despite a fairly comprehensive search of the literature and the Internet, there is a paucity of information comparing Cranial Electrotherapy Stimulator (CES) devices with each other in terms of mechanism of action or efficacy. While cranial electrotherapy devices can have markedly different waveforms, they all seem to have similar benefits for scientific reasons that are not yet clear.
Cranial Electrotherapy Stimulation (CES) essentially consists of applying a very low current that is typically pulsed at 0.5 to 500 Hz to the temples, mastoid processes, or earlobes. It is believed to modulate neurotransmitter systems in the brain, including the serotonergic system. There are some devices on the market that the FDA allows to promote for the treatment of anxiety, depression, and insomnia. The FDA approval was essentially secondary to a “grandfather” clause that allowed them to enter based on evidence of efficacy, as regulations were getting much stricter for newer devices (and drug approval). CES devices require a prescription in the United States. While some people see an immediate benefit, in general, the devices need to be worn for 20-40 minutes a day, at least a few times a week, for about a month to really appreciate the effectiveness.
Although cranial electrotherapy has been around for many years and various devices are “FDA cleared”, there is a marked difference between operating frequencies, duty cycles and consequently waveforms between various devices. . For example, the Fisher Wallace stimulator has a 15,000 Hz square wave carrier modulated at 15 Hz and 500 Hz. The Alpha-Stim SCS is modulated at 0.5 Hz and the CES Ultra operates at 100 Hz. In addition, there are several devices that do not have or have not sought FDA approval, such as the Sota Bio-Tuner, which attaches similarly to the mastoid area or clips to the earlobes as CES devices, and provides 6 output modes different with a base frequency of 1,000 Hz, pulse modulated at 111.11 Hz, but also with options to be further modulated at 0.5 Hz or 7.83 Hz. The Bio-Tuner has more power output than some of the units FDA-approved devices, and if you look at the Fourier frequency spectrum, it actually overlaps in power and frequency with FDA-approved devices.
The research I’ve seen on the efficacy of CES is relatively good and my clinical experience has also been good (I’ve seen good results with the Bio-Tuner as well). Cranial electrotherapy appears to be relatively safe, however CES may be contraindicated if you have a pacemaker, are pregnant, or have a seizure disorder. It can also cause dizziness and nausea, among other side effects, but is generally well tolerated.
All FDA-approved devices appear to have adequate scientific evidence to support their claims of efficacy for anxiety, depression, and insomnia. This is well documented in the literature and also through links on the websites that market and sell the respective devices.
Because devices like the Bio-Tuner are not FDA-approved, just like nutritional supplements, they cannot be marketed to make the claim that they are intended to cure or treat any disease. However, they can be described as used for well-being, health, well-being, and relaxation. And indeed, while there are many testimonials to the benefits of the Bio-Tuner and other similar devices, there is only limited scientific research to back it up for those particular devices.
Thus, despite a fairly exhaustive search of the literature and the Internet, there is a paucity of information as to why any of these devices should perform differently from each other at any of the frequencies, while researchers could speculate that there is a similar mechanism. of action, despite markedly different waveforms. However, there is convincing evidence that applying power to the head as these drives do has some benefit.
More information about these devices, their comparisons, including their costs, and links to their websites can be found on my Psychiatry Alternatives website.