All clinical studies performed with the Fisher Wallace Stimulator® used the same stimulation dosage as Circadia®. Circadia® and the Fisher Wallace Stimulator® are manufactured by Fisher Wallace Laboratories.
Cerebrospinal Fluid And Plasma Neurochemicals Response To Cranial Electrical Stimulation.
Shealy CN, Cady RK, Wilkie RG, et al.
J Neurol Orthop Med Surg 1998;18:94-97. (PubMed link)
Depression: a diagnostic neurochemical profile & therapy with cranial electrical stimulation (CES).
R.K., Wilkie, R.G., Cox, R.H., Liss, S., Closson, W. The Journal of Neurological & Orthopaedic Medicine & Surgery. Dec 1989. 10(4):319-321.
Liss, S, Liss B. Presented at the American Academy of Pain Management Conference Las Vegas, Nevada---September 1999
Physiological and Therapeutic Effects of High Frequency Electrical Pulses.
Liss S, Liss B.
Integr Physiol Behav Sci. 1996 Apr-Jun;31(2):88-95.(PubMed link)
Alternating low frequency stimulation of medial septal and commissural fibers induces NMDA-dependent, long-lasting potentiation of hippocampal synapses in urethane-anesthetized rats.
Habib D, Dringenberg HC.
Hippocampus. 2009 Mar;19(3):299-307. doi: 10.1002/hipo.20507. (PubMed link)
Potential and current density distributions of cranial electrotherapy stimulation (CES) in a four-concentric-spheresmodel.
Ferdjallah M, Bostick FX Jr, Barr RE.
IEEE Trans Biomed Eng. 1996 Sep;43(9):939-43. (PubMed link)
Is Transcranial Electrical Stimulation (TCES) a safe intervention for children with Cerebral Palsy?
Alon, G, Syron S, Smith G
Neurorehabil Neural Repair June 1998 vol. 12 no. 2 65-71
We tested the safety of transcranial electrical stimulation (TCES) applied to seven children (age range 2.5 to 7.5 years) with a confirmed diagnosis of cerebral palsy (CP). Adverse responses were assessed by negative changes in the gross motor function measure test (GMFM), the popliteal angle, and the occurrence of any undesired systemic responses such as seizure, nausea, vomiting, or sleep disruption. The tests first were given before the commencement of a physical therapy exercise (PTE) program combined with a home program of TCES. The tests were repeated after 8 weeks of PTE + TCES and once again after an additional 8 weeks of PT + TCES. One of the 8- week periods involved placebo stimulation in a double-blind design. Stimulator amplitude was 0.5 mA of peak current, phase charge was 0.0166 C, and the averaged RMS current was 249 microamperes. This level was below threshold of sensory nerve excitation, and the child did not perceive the stimulation. Electrodes were placed over the right and left temporal areas of the skull. The stimulation was applied by the parents for 10 minutes, twice a day, 7 days each week. The total goal GMFM scores were greater after both active and placebo stimulation. The popliteal angle improved irrespective of the stimulation intervention. No adverse systemic responses were reported. These results support the hypothesis that TCES as used in this study is a safe procedure.Open PDF
Cranial Electrotherapy Stimulation: A Safe Neuromedical Treatment for Anxiety, Depression, or Insomnia
Gilula, Marshall F. MD; Barach, Paul R. MD, MPH
Southern Medical Journal. 2004; Vol. 97(12).
Cognitive, mood, and electroencephalographic effects of noninvasive cortical stimulation with weak electrical currents.
Tadini L, El-Nazer R, Brunoni AR, Williams J, Carvas M, Boggio P, Priori A, Pascual-Leone A, Fregni F.
J ECT. 2011 Jun;27(2):134-40. doi: 10.1097/YCT.0b013e3181e631a8. (PubMed link)
OBJECTIVES:The use of noninvasive cortical electrical stimulation with weak currents has significantly increased in basic and clinical human studies. Initial, preliminary studies with this technique have shown encouraging results; however, the safety and tolerability of this method of brain stimulation have not been sufficiently explored yet. The purpose of our study was to assess the effects of direct current (DC) and alternating current (AC) stimulation at different intensities in order to measure their effects on cognition, mood, and electroencephalogram.
METHODS:Eighty-two healthy, right-handed subjects received active and sham stimulation in a randomized order. We conducted 164 ninety-minute sessions of electrical stimulation in 4 different protocols to assess safety of (1) anodal DC of the dorsolateral prefrontal cortex (DLPFC); (2) cathodal DC of the DLPFC; (3) intermittent anodal DC of the DLPFC and; (4) AC on the zygomatic process. We used weak currents of 1 to 2 mA (for DC experiments) or 0.1 to 0.2 mA (for AC experiment).
RESULTS: We found no significant changes in electroencephalogram, cognition, mood, and pain between groups and a low prevalence of mild adverse effects (0.11% and 0.08% in the active and sham stimulation groups, respectively), mainly, sleepiness and mild headache that were equally distributed between groups.
CONCLUSIONS: Here, we show no neurophysiological or behavioral signs that transcranial DC stimulation or AC stimulation with weak currents induce deleterious changes when comparing active and sham groups. This study provides therefore additional information for researchers and ethics committees, adding important results to the safety pool of studies assessing the effects of cortical stimulation using weak electrical currents. Further studies in patients with neuropsychiatric disorders are warranted.