Description: Class IIa, Type BF medical device generating microcurrent pulses that are thought to reach the brain directly via ear lobe stimulation with up to 42% reaching the thalamic area (through a perineuroal or vascular pathway via the auditory meatus) and stimulating the release of neurotransmitters. Frequency: 0.5 to 600 uA. Output: 4.0 mA maximum. Waveform: Bipolar asymmetric rectangular waves, 50% 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 tryptophane levels decreased. Electrical engineering studies found that a small fraction of CES current 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 160%-215% 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.
Contraindications: Do not use this product if you are pregnant or lactating without first seeking advice from your physician. Do no use if you have a cardiac pacemaker (particularly demand type pacemakers) or other implanted bioelectric equipment without first consulting your physician. There have been isolated reports of CES treatment lowering blood pressure so care should be taken while using CES in conjunction with high blood pressure medication. Do not use this product on children under the age of 7.
Dosage and Administration: Instructions for Use
After you have received initial instructions and a practice session on the CES unit with your therapist you will be able to self-administer treatment.
PRIOR TO TREATMENT: A daily global subjective distress (1-10) rating should be taken where appropriate to track improvement of your target symptom. See our office for a form you can use or simply make a notation on you calendar. You may either prepay for your CES session(s) during your meeting with your doctor or leave a check for $15 in the envelope in the envelope inside the back cover of the blue CES sign-up sheet folder.
PRECAUTIONS: Optimally CES treatment should be applied in early hours after awakening and while in relaxed and quiet environment. Normally it is best not to use CES within three hours of bedtime. Exercise caution when driving or operating machinery for one hour after treatment. Do not apply electrodes directly over the eyes or the carotid sinus area (upper side of the neck below the ear and behind the jaw). Do not sleep during CES treatment.
SCS UNIT USE: Set the unit to 0 using green wheel on right side. The CES unit will have soft felt pads on each of the ear clips. Tear open one of the alcohol wipe packets and use the wipe on both of your ears. Then put a few drops of saline nasal spray on each of the felt pads and place the clips just like earrings according to the attached diagram at the "Relaxation Point" or on the ear lobe itself if the former is uncomfortable. Press the left side of the glossy plastic button on the front of the unit for 20 minutes and then the right button if you wish to go to 60 minutes. Get into a relaxed position and begin to gradually turn up the level (green dial on right side) to highest comfortable level. This is usually the point at which the tingling or pulsing feeling on your earlobes begins to become uncomfortable and generally in the "2" Hz range. (Do not go above level 4 on the dial.) The pulsing feeling that many people experience in their earlobes is normal and means the machine is working correctly. There is no way that the CES unit can be harmful to you so you can relax and enjoy the session. It is fine to read, mediate, and listen to music or just rest. Try not to fall asleep during the CES session, but it will not hurt you to do so.
CES UNIT USE: Check settings by making sure "CH1" switch is set at "0.5 Hz". "CH2" should be set at "CH1" position. "Intensity" should be set at "0" when unit is first turned on. The CES unit will have soft felt pads on each of the ear clips. Tear open one of the alcohol wipe packets and use the wipe on both of your ear lobes. Then put a few drops of saline nasal spray on each of the felt pads and place the clips just like earrings on your left and right ear lobes or on the "Relaxation Point" (see attached diagram). TO BEGIN THE CES TREATMENT SESSION: Once you are all ready to begin. Depress the "Power" button once and the countdown timer at the top on the CES unit will begin to count down from 30-minutes. Get into a relaxed position and begin to gradually turn up the "CH1 Intensity" level (green dial on upper left-hand side of unit) to highest comfortable level. This is usually the point at which the tingling or pulsing feeling on your earlobes begins to become uncomfortable and generally in the 2 Hz range. (Do not go but not go above level 5 on the dial.) The pulsing feeling that many people experience in their earlobes is normal and means the machine is working correctly. There is no way that the CES unit can be harmful to you so you can relax and enjoy the session. It is fine to read, mediate, and listen to music or just rest. Try not to fall asleep during the CES session, but it will not hurt you to do so. If you have arranged double 60 minute session simply set the CES unit timer accordingly or turn the "Power" button off and back on again after each 20 minute session.
FREQUENCY AND DURATION: Optimal CES treatments are 60 minutes once daily or 30 minutes two times daily for the first three weeks. In some studies 40 minutes 1 time per day, five days per week has been found to be adequate. For chronic conditions many patients find CES is actually more effective when used every other day. After first two weeks of daily treatment application may be reduced to maintenance level ranging from one 20-minute application every other day to one 20-minute application every three days. Treatment should not be discontinued as ineffective until 2 weeks of twice daily applications have been completed. It is very important to be aware of feelings of altered weight-perception ("heaviness" or "lightness") during a treatment session. The patient may feel worse if the treatment is discontinued while feeling heavy. It is important to continue the treatment if the patient feels heavy at the end of the allotted time, even if it has already been 60 minutes or more. Continue for at least two to five minutes after the patient feels "lighter".
FOLLOWING CES TREATMENT: Use caution in operating a motor vehicle or other potentially dangerous mercenary until you get used to how you feel after CES treatment. We suggest you take it easy and avoid stressful situation for at least an hour after CES treatment. Try and move slowly, taking your time and breathing calmly and deeply into your abdomen. We also suggest you drink at least 2 full glasses of water in the first hour after CES treatment. Make a note of any unusual or interesting phenomena you experience and discuss these with your doctor at your next session or before is necessary.
COMBINED USE WITH MEDICATIONS: Cranial Electric Stimulation can be used in conjunction with analgesic, psychoactive and vascular medications. In general CES tends to potentiate, or cause an increase in, the effectiveness of these medications. Medication dosage should thus be closely monitored and reduced is necessary. The following technical information about the CES can be shared with your prescribing physician who may also request copies of research articles from our office. Medication for high blood pressure should be monitored carefully as it may need to be reduced.
SPECIALIZED TREATMENT NOTES: Anxiety: CES can be used on a preventive and, or emergent basis.
Insomnia: Reduced frequency of treatment needed (20 minutes once daily tapering after two weeks to 3 treatments weekly). Optimal treatment time during circadian rise immediately preceding sleep (e.g. 4-7 p.m. if bedtime 10:00 p.m.) Primary treatment affect is in Stage 4 (delta) sleep. Ambiguous REM occasionally occurs during treatment. Headache: Treat headache as soon as possible after first warning signs and not later than one hour after onset. Patch electrodes should be placed on alternate sides of temple. Can be used in conjunction with analgesic and vascular medications.
Clinical Effect In: Response to CES treatment is very individual. Treatment effects tend to be cumulative. Relief for anxiety conditions, insomnia and attentional problem is normally experienced by the second treatment with stable recovery by the seventh treatment. Mild depression and mild chronic pain conditions generally remit by the end of the tenth day of treatment. When brain neurotransmitters are back in balance no further improvement will be noticed. Maintenance treatments are sometimes needed at 2 to 3 twenty-minute sessions per week.
Adverse Reactions: Generally well tolerated. Some persons may experience initial anxiety related to novelty of the CES procedure and, or pulsating feeling generated by electrodes against the skin. Other adverse reactions: Dizziness (0.15%), skin irritation (0.12%), headaches (0.22%). Rare paradoxical reactions such as hyperexcited states, increased anxiety, and sleep disturbance have occurred. Some CES studies have demonstrated a exacerbation of preexisting depression in some individuals. No impairment of consciousness or reaction time has been reported in clinical studies. No studies have been conducted on long-term use of this product. If you suspect that an herb or other supplement is making you sick, call the FDA's MedWatch hotline at 800-332-1088 or contact the agency via its website at http://www.fda.gov/medwatch.
Known Interactive Effects: CES treatment may interact with over-the-counter, herbal, hormonal, or enzymatic medications prescribed for the treatment of psychological conditions including anxiety, depression, or insomnia including drugs which affect brain serotonin levels or for pain and other neurologic conditions. In such situations close supervision by psychological or medical personnel is recommended.
Additional Considerations: There eight different types of CES units of which the LISS, ALPHA-STIM and LIMOGE are the most common. CES units are available through Mind/Body Consultant Services through the following programs:
Warnings: The information above is provided for educational purposes and may not be construed as a medical prescription or as a substitute for the advice of your physician. Do not use this product without first consulting your physician especially if you are pregnant or lactating. You should regularly consult your physician in matters regarding your health and particularly in respect to symptoms and conditions which may require diagnosis or medical attention. Reevaluate use of this product after 6 months. Dr. Christian R. Komor, the Komor Healthcare Offices, and Mind/Body Consulting Services, P.C. disclaim any liability arising directly or indirectly from the use of the above information.