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

Content Provider	Springer Nature : BioMed Central
Author	Xu, Chengwei Yuan, Zhanxing Chen, Zerong Liao, Ziqin Li, Shuiyan Feng, Yanqi Tang, Ziqiang Nian, Jichan Huang, Xiyan Zhong, Haili Xie, Qiuyou
Abstract	Background 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. Methods 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. Results 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). Conclusions 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. Trial registration www.ClinicalTrials.gov , identifier: NCT05187000.
Related Links	https://jneuroengrehab.biomedcentral.com/counter/pdf/10.1186/s12984-024-01455-1.pdf
Ending Page	15
Page Count	15
Starting Page	1
File Format	HTM / HTML
ISSN	17430003
DOI	10.1186/s12984-024-01455-1
Journal	Journal of NeuroEngineering and Rehabilitation
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2024-09-19
Access Restriction	Open
Subject Keyword	Neurosciences Neurology Rehabilitation Medicine Biomedical Engineering and Bioengineering Repetitive transcranial magnetic stimulation Disorders of consciousness Minimally conscious state EEG TMS-EEG Perturbational complexity index Randomized control trial
Content Type	Text
Resource Type	Article
Subject	Health Informatics Rehabilitation
Journal Impact Factor	5.2/2023
5-Year Journal Impact Factor	5.6/2023

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