Safety

warnings:

tCS therapy should be supervised by a trained medical doctor. Modalities other than tDCS (tACS, tRNS) are for research purposes only. There are no studies in the literature describing the effects of direct current treatments on pregnant women, or children below 18 years, or patients with pacemakers, intracranial electrodes, implanted defibrillators, or any other prosthesis. Before applying StarStim, make sure that pacemakers, intracranial electrodes, defibrillators, or any other prosthesis are not implanted in the patient. Otherwise, the application of DC currents could be unsafe. For safety, StarStim is limited in the following ways. It will not operate if the contact impedance is above 20 kOhm. It can only provide potential differences across electrode of 30 V to deliver a maximum, at any electrode of (+ or -) 2 mA of current. Based on abundant literature, the guideline for clinical use is to keep average current densities in electrodes below 2 mA/35 cm2= 0.06 mA/cm2. Such stimulation current densities are far from the threshold for tissue damage (14.3 mA/cm2) recently indicated for tDCS in an animal model. Current densities above 0.06 mA/cm2 (but always well below 14.3 mA/cm2) are for advanced clinical or research purposes only. Stimulation session durations beyond 40 minutes are for research purposes only. In addition, electrode positions above cranial foramina and fissures should be avoided because these could increase beyond safety limits the effective current density. StarStim can only be used with specifically designed Neuroelectrics electrodes. With sponge electrodes, the use of sodium chloride solution, the regular replacement of the sponge, and the careful inspection of the condition of the skin under the electrode before and after tDCS is recommended. Observed Adverse Effects include: skin itching, tingling, headache, burning sensation and discomfort. In rare cases, skin lesions have been observed. If skin lesions are observed, the treatment must be suspended and the equipment revised. StarStim components must never be opened or damaged. Before using check that StarStim components, including electrodes, are undamaged and clean.

The following chart will be provided to guide operators.

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It illustrates the MAX average current density that can be used for mainstream clinical applications, advanced clinical applications, research as a function of electrode size.

The proposed limits are not based on available negative evidence (i.e., findings of Adverse Effects with higher current densities). Rather, it is a conservative statement based on the limited experience with current densities above 2 mA/35 cm2).