Lin Ashleigh Peng, Chiu Chun-Chieh, Chen Shih-Ching, Huang Yi-Jing, Lai Chien-Hung, Kang Jiunn-Horng
Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, Taipei 110, Taiwan.
Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan.
Life (Basel). 2022 Aug 31;12(9):1364. doi: 10.3390/life12091364.
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.
本研究旨在探讨高清晰度经颅交流电刺激(HD-tACS)作用于左侧初级运动皮层(M1)治疗纤维肌痛(FM)患者的安全性和有效性。方法:在这项随机、双盲、假刺激对照的临床试验中,在一家教学医院招募FM患者。38例患者被随机分为主动HD-tACS组(n = 19)或假刺激组(n = 19)。主动刺激包括每天一次,以1 mA的HD-tACS对左侧M1进行20分钟刺激,共十次,为期两周。主要结局是疼痛强度和生活质量的变化,在基线和治疗两周后使用数字评定量表(NRS)和纤维肌痛影响问卷(FIQ)进行评估。次要结局包括FM的其他核心症状(心理困扰、睡眠质量、通过压力痛阈测量的痛觉过敏)以及生物标志物总 Tau 和 Aβ1-42 的变化。所有分析均基于意向性分析,显著性水平为 p < 0.05。结果:38例随机分组的患者中,35例完成了研究。两周后,HD-tACS 导致治疗后 FIQ 评分显著降低。然而,与假刺激相比,NRS 和 FIQ 评分没有显著差异。大多数不良事件严重程度较轻。尽管如此,一名接受 HD-tACS 的患者在试验期间企图自杀。结论:这些结果表明,HD-tACS 可能有效减轻 FM 患者的疼痛、心理困扰和症状影响。然而,我们发现两组之间没有显著差异。有必要开展未来研究以调查 HD-tACS 在 FM 中的作用。