Department of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Clinical Research Center, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Trials. 2023 Apr 1;24(1):249. doi: 10.1186/s13063-023-07122-5.
Repetitive transcranial magnetic stimulation (rTMS), as a non-invasive brain stimulation technique, has shown potentials for consciousness recovery of patients with disorders of consciousness (DoC), as, to a certain extent, it is effective in regulating the excitability of central nervous system. However, it is difficult to achieve satisfactory effect with "one size fits all" rTMS treatment due to different clinical conditions of patients. There is an urgent need to develop individualized strategy to improve the effectiveness of rTMS on patients with DoC.
Our protocol is a randomized double-blind sham-controlled crossover trial that includes 30 DoC patients. Each patient will received 20 sessions, in which 10 sessions will be rTMS-active stimulus, and the other 10 sessions will be sham stimulus, separated by no less than 10 days' washout period. The rTMS-active will include 10 Hz rTMS over the individualized-targeted selection area for each patient according to the different insult regions of the brain. Coma Recovery Scale-Revised (CRS-R) will be used as primary outcome at baseline, after the first stage of stimulation, at the end of the washout period, and after the second stage of stimulation. Secondary outcomes will be measured at the same time, including efficiency, relative spectral power, and functional connectivity of high-density electroencephalograph (EEG). Adverse events will be recorded during the study.
rTMS has obtained grade A evidence in treating patients with several central nervous system diseases, and there has been some evidence showing partial improvement on level of consciousness in DoC patients. However, the effectiveness of rTMS in DoC is only 30~36%, mostly due to the non-specific target selection. In this protocol, we present a double-blind crossover randomized sham-controlled trial based on the individualized-targeted selection strategy that aims to study the effectiveness of rTMS therapy for DoC, and the result may provide new insights to non-invasive brain stimulation.
ClinicalTrials.gov : NCT05187000. Registered on January 10, 2022.
重复经颅磁刺激（rTMS）作为一种非侵入性脑刺激技术，在一定程度上能够调节中枢神经系统的兴奋性，显示出对意识障碍（DoC）患者意识恢复的潜力。然而，由于患者的临床情况不同，“一刀切”的 rTMS 治疗很难达到满意的效果。因此，迫切需要制定个体化策略来提高 rTMS 对 DoC 患者的疗效。
本方案为一项随机、双盲、假刺激对照交叉试验，纳入 30 例 DoC 患者。每位患者将接受 20 次治疗，其中 10 次为 rTMS 主动刺激，另外 10 次为假刺激，间隔不少于 10 天的洗脱期。rTMS 主动刺激将包括根据大脑不同损伤区域对每位患者进行个体化靶向选择区域的 10 Hz rTMS。以昏迷恢复量表修订版（CRS-R）作为基线、第一阶段刺激结束、洗脱期结束和第二阶段刺激后的主要结局。同时测量次要结局，包括高密度脑电图（EEG）的效率、相对频谱功率和功能连接。研究期间将记录不良事件。
rTMS 在治疗几种中枢神经系统疾病方面已获得 A 级证据，并且有一些证据表明它对 DoC 患者的意识水平有一定程度的改善。然而，rTMS 在 DoC 中的有效性仅为 30%~36%，主要原因是目标选择非特异性。在本方案中，我们提出了一项基于个体化靶向选择策略的双盲交叉随机假刺激对照试验，旨在研究 rTMS 治疗 DoC 的疗效，结果可能为非侵入性脑刺激提供新的见解。
ClinicalTrials.gov：NCT05187000。于 2022 年 1 月 10 日注册。
