Description: Class IIa. Type BF medical device generating microcurrent pulses that are thought to reach the brain directly via ear lobe stimulation with 42% reaching the cortex through a perineural or vascular pathway via the auditory meatus. Frequency: 0.5 to 60hz. Output: 4.0 mA maximum. Waveform: Bipolar asymmetric rectangular waves, 500/a duty cycle. 0 net current. Average current density in brain tissue: 1 mA: 5-18 uA per cm. Electric field in brain tissue at 1 mA: 2.8 to 8 mV per cm.

Method of Action: Cranial electrostimulation uses microcurrent pulsed high frequency carrier waves (15,000 Hz) which utilizes the bulk capacitance of the body and a modulating bioactive frequency at low current levels to reestablish optimal neurotransmitter levels and functioning in the brain. CES differs from traditional transcutaneous electrical nerve stimulation (TENS) which is low-frequency (200 Hz or less), high-current (hundreds of mA) modality. Low-level electrical current interacts with cell membranes in a manner that produces modifications in information transduction associated with classical second messenger pathways, calcium channels and cyclic AMP. The activity/levels of MAO-B in blood platelets, CSF and plasma serotonin beta endorphin GABA concentration in blood. DHEA, 5-hydroxy-indol-acetic acid and enkephalins were all increased in experimental groups after 20 CES procedures. Cortisol and trvptophane levels decreased. Electrical engineering studies found that a small fraction of CES current actually reaches the thalamic area of the brain facilitating the release of neurotransmitters as noted above. A decrease in the latency of alpha-rhythm appearance at sleep onset has also been recorded with CES use evidencing reduced rigidity in the CNS stimulation process and enhanced activity of the alpha-rhythm generating systems.

Indications and Usage: In carefully conducted randomized controlled trials CES has repeatedly shown efficacy in treating mild to moderate primary or secondary anxiety and depressive conditions, normalization of central hemodynamics (systolic and diastolic blood pressure but not peripheral vascular tension) in Stage I hypertension, relieving headache pain (85%) and other types of pain conditions including pain resulting from dental surgery and cancer (35%), and especially in potentiating through centrally-mediated action the effect of analgesic drugs (fentanyl 176%-306%, morphine 174%-306%, alfentanil I 60%-2 15% and dextromoramide 267%-392%), or replacing them altogether and increasing the depth of anesthesia (In one study fentanyl use decreased by 31%.). and increasing attention and the ability to learn new tasks. To a lesser degree CES has been shown effective in relieving primary insomnia (particularly sleep-onset insomnia), mild depression, post-axonic spasticity, minimal brain dysfunction and mood changes subsequent to closed head injury (with corresponding decrease in the need to neuroleptic drugs). Efficacy of CES has been researched in regards to substance abuse recovery (including nicotine and opiate addiction) with mixed results.