2.3 Treatment
ADVERSE EFFECTS
We applied the neuro-navigated iTBS [The iTBS treatment was applied twice daily with a 15-min interval to promote plasticity [Moreover, in all patients, two transcutaneous electrical nerve stimulation (TENS) electrodes were placed on the forehead directly beneath the center of the coil. Thereby, a current of up to 4 mA, synchronized with the TMS pulses and scaled to the magnetic stimulator’s output intensity, was delivered in the sham group, to simulate the tactile sensation of active stimulation on the scalp. Therefore, similar to the active treatment, sham treatment patients might require extra treatment days to achieve the intended strength of the TENS stimulation. Notably, because of this aspect of the study, we were able to have a similar number of treatment days for the active and sham groups.Prior to the first treatment session, the type of treatment (i.e., active or sham) was decided through a randomization process (computerized pseudorandom number with Mersenne Twister algorithm), determining which side of the coil (i.e., not shielded or shielded) to use for each patient. Specifically, a randomization code was prepared by a third person other than the magnetic stimulator’s operating nurse and entered in the stimulator’s research software. Consequently, the software guided the operator as to which side of the coil should be angled towards the patient. Not to mention that if the patient was assigned to the sham treatment group, the research software automatically activated the TENS stimulation. Moreover, during treatment, daily monitoring for potential adverse effects was conducted. No serious harm or unintended effect was observed in either of the treatment groups. It is worth to further noting that there was no difference in the number of treatment days across active and sham groups [