Objectives: This study aimed to investigate the safety and efficacy of high-definition transcranial alternating current stimulation (HD-tACS) to the left primary motor cortex (M1) in the treatment of fibromyalgia (FM) patients. Methods: In this randomized, double-blind, sham-controlled clinical trial, patients with FM were recruited in a teaching hospital. Thirty-eight patients were randomized to active HD-tACS (n = 19) or sham stimulation (n = 19). Active stimulation included a daily session of 20-min stimulation of 1 mA HD-tACS over the left M1 for ten sessions in two weeks. The primary outcome was the change in pain intensity and quality of life, assessed using the numeric rating scale (NRS) and the fibromyalgia impact questionnaire (FIQ) at baseline and after two weeks of treatment. Secondary outcomes included other core symptoms of FM (psychological distress, sleep quality, hyperalgesia measured by pressure pain threshold) and changes in biomarkers’ total Tau and Aβ1-42. All analyses were based on intention-to-treat for a significance level of p < 0.05. Results: Of the 38 randomized patients, 35 completed the study. After two weeks, HD-tACS induced a significant reduction in FIQ score post-treatment. However, there were no significant differences in NRS and FIQ scores compared to sham stimulation. Most adverse events were mild in severity. Nevertheless, one patient receiving HD-tACS attempted suicide during the trial. Conclusions: These results suggest that HD-tACS may effectively reduce pain, psychological distress, and symptom impacts in FM patients. However, we found no significant differences between the two groups. Future studies investigating HD-tACS in FM are warranted.
Keywords: fibromyalgia; high-definition; neuromodulation; pain; quality of life; transcranial stimulation.