Evaluation of tolerability and safety of transcranial electrical stimulation with gel particle electrodes in healthy subjects.

Background: With the advancement of transcranial electrical stimulation (tES) technology, an increasing number of stimulation devices and treatment protocols have emerged. However, safety and tolerability remain critical concerns before new strategies can be implemented. Particularly, the use of gel particle electrodes brings new challenges to the safety and tolerability of tES, which hinders its widespread adoption and further research.

Objective: Our study utilized a specially designed and validated transcranial electrical stimulation stimulator along with preconfigured gel particle electrodes placed at F3 and F4 in the prefrontal lobes. We aimed to assess the tolerance and safety of these electrodes in healthy subjects by administering different durations and types of tES.

Methods: Each participant underwent ten sessions of either transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS), with session durations varying. In the experiment, we collected various measurement data from participants, including self-report questionnaire data and behavioral keystroke data. Tolerability was evaluated through adverse events (AEs), the relationship of adverse events with tES (AEs-rela), the Self-Rating Anxiety Scale (SAS), and the Visual Analog Mood Scale-Revised (VAMS-R). Safety was assessed using the Visual Analog Scale (VAS), the Skin Sensation Rating (SSR), Montreal Cognitive Assessment (MoCA), and Stroop task. These data were analyzed to determine the impact of different parameters on the tolerability and safety of tES.

Results: There were no significant changes in the results of the MoCA and SAS scales before and after the experiment. However, significant differences were observed in VAS, SSR, AEs, and AEs-rela between tDCS and tACS. Additionally, fatigue increased, and energy levels decreased on VAMS-R with longer durations. No significant differences were found in other neuropsychological tests.

Conclusion: Our study revealed significant differences in tolerability and safety between tDCS and tACS, underscoring the importance of considering the stimulation type when evaluating these factors. Although tolerance and safety did not vary significantly across different stimulation durations in this study, future research may benefit from exploring shorter durations to further assess tolerability and safety efficiently.