Effect of transcranial electrical stimulation on serum interleukin-1β levels in COVID-19 patients: A randomized prospective study

Background. Interleukin-1β plays an important role in the pathogenesis of coronavirus disease (COVID-19) and may also be informative as a prognostic marker of infection. Other widely used diagnostic and prognostic markers include C-reactive protein and ferritin. Objective. To evaluate the effect of transcranial electrical stimulation on the serum levels of interleukin-1β, C-reactive protein, and ferritin in moderate to severe COVID-19 patients who do not receive targeted anti-cytokine therapy. Methods. The conducted randomized prospective study included patients treated at the Regional Clinical Hospital No. 2 (Ministry of Health of the Krasnodar Krai) in the period from June 24, 2021 to February 23, 2022. The patients diagnosed with moderate to severe COVID-19 were divided into two groups: comparison group (n = 20) receiving standard treatment as per the current guidelines and a group (n = 15) in which, in addition to standard therapy, the patients received transcranial electrical stimulation (one session per day until day 7 of stay in the COVID ward). The study excluded patients receiving specific anti-cytokine therapy (monoclonal antibodies, kinase inhibitors, and recombinant cytokine receptor antagonists). The levels of interleukin-1β, C-reactive protein, and ferritin were assessed prior to treatment and at the end of the first week of therapy. Statistical analysis and data visualization were performed in the R environment (The R Foundation, Austria). Differences were considered statistically significant at p < 0.05. Results. Prior to treatment, no statistically significant differences were observed in the levels of interleukin-1β, C-reactive protein, and ferritin between the groups. By the end of the first week, the level of interleukin-1β decreased by 11.8% (p = 0.7) in the comparison group, which was not statistically significant. In the group receiving transcranial electrical stimulation, interleukin-1β levels exhibited a significant decrease (by 71%) from the baseline (p = 0.007). In addition, interleukin-1β levels in this group were 52% lower than in the comparison group (p = 0.005). Also, C-reactive protein levels decreased significantly in both groups, while ferritin levels did not exhibit any statistically significant changes. Conclusion. The use of transcranial electrical stimulation in combination therapy for moderate to severe COVID-19 patients results in a more pronounced decrease in serum interleukin-1β levels as compared to standard therapy, which may indicate the anti-inflammatory potential of this method.