Perturbational complexity index in assessing responsiveness to rTMS treatment in patients with disorders of consciousness: a cross-over randomized controlled trial study

IF 5.2 2区 医学 Q1 ENGINEERING, BIOMEDICAL Journal of NeuroEngineering and Rehabilitation Pub Date : 2024-09-19 DOI:10.1186/s12984-024-01455-1
Chengwei Xu, Zhanxing Yuan, Zerong Chen, Ziqin Liao, Shuiyan Li, Yanqi Feng, Ziqiang Tang, Jichan Nian, Xiyan Huang, Haili Zhong, Qiuyou Xie
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Abstract

Disorders of Consciousness (DoC) caused by severe brain injuries represent a challenging clinical entity, which is easy to misdiagnosis and lacks effective treatment options. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive neuroelectric stimulation method that shows promise in improving consciousness for DoC, especially in minimally conscious state (MCS). However, there is little evidence of its effectiveness, especially in RCT studies. Twenty MCS patients participated in a double-blind, randomized, crossover, sham-controlled clinical study to evaluate the safety and efficacy of rTMS for MCS. Subjects were randomized into two groups: one group received rTMS-active for 10 consecutive days (n = 10), and the other group received rTMS-sham for 10 consecutive days (n = 10). After a 10-day washout period, the two groups were crossed over and received the opposite treatment. the rTMS protocol consisted of 2,000 pulses per day in the left dorsolateral prefrontal cortex (L-DLPFC), sent at 10 Hz. The stimulation intensity was 90% of the resting motor threshold. Coma Recovery Scale Revised (CRS-R), the main evaluation index, was evaluated before and after each phase in a double-blind manner. Meanwhile RS-EEG and TMS-EEG data were acquired and relative alpha power (RAP), and perturbational complexity index based on state transitions (PCIst) were caculated. One-way ANOVA revealed significantly higher scores in rTMS-active treatment compared to rTMS-sham across various measures, including CRS-R total score, RAP, PCIst (all P < 0.05). Among the 20 MCS patients, 7 (35%) were identified as responders following rTMS treatment. Compared to rTMS-sham, responder scores for CRS-R, RAP, and PCIst (all P < 0.05) were significantly elevated after rTMS-active treatment. Conversely, there was no significant difference observed in non-responders. Furthermore, post-hoc analysis revealed that baseline PCIst was significantly higher in responders than non-responders. Upon a 6-month follow-up, CRS-R scores significantly increased in all 20 patients (P = 0.026). However, the responder group exhibited a more favorable prognosis compared to the non-responder group (P = 0.031). Applying 10 Hz rTMS to L-DLPFC significantly increased consciousness level in MCS patients. PCIst is a neurophysiological index that has the potential to evaluate and predict therapeutic efficacy. www.ClinicalTrials.gov , identifier: NCT05187000.
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评估意识障碍患者对经颅磁刺激治疗反应的扰动复杂性指数:一项交叉随机对照试验研究
严重脑损伤导致的意识障碍(DoC)是一种极具挑战性的临床症状,容易误诊且缺乏有效的治疗方案。重复经颅磁刺激(rTMS)是一种非侵入性神经电刺激方法,有望改善意识障碍患者的意识,尤其是在微意识状态(MCS)下。然而,有关其有效性的证据很少,尤其是在 RCT 研究中。20 名 MCS 患者参加了一项双盲、随机、交叉、假对照临床研究,以评估经颅磁刺激治疗 MCS 的安全性和有效性。受试者被随机分为两组:一组连续 10 天接受经颅磁刺激激活治疗(n = 10),另一组连续 10 天接受经颅磁刺激假对照治疗(n = 10)。经颅磁刺激方案包括每天对左侧背外侧前额叶皮层(L-DLPFC)进行 2000 次脉冲刺激,频率为 10 Hz。刺激强度为静息运动阈值的 90%。昏迷恢复量表修订版(CRS-R)是主要的评估指标,以双盲方式在每个阶段前后进行评估。同时采集 RS-EEG 和 TMS-EEG 数据,并计算相对α功率(RAP)和基于状态转换的扰动复杂性指数(PCIst)。单因素方差分析显示,在 CRS-R 总分、RAP、PCIst 等各项指标上,经颅磁刺激主动治疗的得分明显高于经颅磁刺激被动治疗的得分(P 均小于 0.05)。在 20 名多发性硬化症患者中,有 7 人(35%)被确定为经颅磁刺激治疗后的应答者。与经颅磁刺激-sham相比,经颅磁刺激-active治疗后,CRS-R、RAP和PCIst的应答者得分(均为P < 0.05)显著升高。相反,在无反应者中没有观察到明显差异。此外,事后分析显示,有反应者的基线 PCIst 明显高于无反应者。在 6 个月的随访中,所有 20 名患者的 CRS-R 评分都有明显提高(P = 0.026)。不过,与无反应组相比,有反应组的预后更佳(P = 0.031)。对 L-DLPFC 进行 10 Hz 经颅磁刺激可显著提高多发性硬化症患者的意识水平。PCIst是一种神经生理指标,具有评估和预测疗效的潜力。www.ClinicalTrials.gov ,标识符:NCT05187000.
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来源期刊
Journal of NeuroEngineering and Rehabilitation
Journal of NeuroEngineering and Rehabilitation 工程技术-工程:生物医学
CiteScore
9.60
自引率
3.90%
发文量
122
审稿时长
24 months
期刊介绍: Journal of NeuroEngineering and Rehabilitation considers manuscripts on all aspects of research that result from cross-fertilization of the fields of neuroscience, biomedical engineering, and physical medicine & rehabilitation.
期刊最新文献
Non-invasive brain stimulation enhances motor and cognitive performances during dual tasks in patients with Parkinson's disease: a systematic review and meta-analysis. Myoelectric motor execution and sensory training to treat chronic pain and paralysis in a replanted arm: a case study. Selective nociceptive modulation using a novel prototype of transcutaneous kilohertz high-frequency alternating current stimulation: a crossover double-blind randomized sham-controlled trial. A fuzzy-logic approach for longitudinal assessment of patients' psychophysiological state: an application to upper-limb orthopedic robot-aided rehabilitation. Effects of different types of high-definition transcranial electrical stimulation on visual working memory and contralateral delayed activity.
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