Abstract：
Transcranial direct current stimulation (tDCS) has been shown to improve signs of consciousness in a subset of patients with disorders of consciousness (DoC). However, no multicentre study confirmed its efficacy when applied during rehabilitation. In this randomized controlled double-blind study, the effects of tDCS whilst patients were in rehabilitation were tested at the group level and according to their diagnosis and aetiology to better target DoC patients who might repond to tDCS.
Patients received 2 mA tDCS or sham applied over the left prefrontal cortex for 4 weeks. Behavioural assessments were performed weekly and up to 3 months\' follow-up. Analyses were conducted at the group and subgroup levels based on the diagnosis (minimally conscious state [MCS] and unresponsive wakefulness syndrome) and the aetiology (traumatic or non-traumatic). Interim analyses were planned to continue or stop the trial.
The trial was stopped for futility when 62 patients from 10 centres were enrolled (44 ± 14 years, 37 ± 24.5 weeks post-injury, 18 women, 32 MCS, 39 non-traumatic). Whilst, at the group level, no treatment effect was found, the subgroup analyses at 3 months\' follow-up revealed a significant improvement for patients in MCS and with traumatic aetiology.
Transcranial direct current stimulation during rehabilitation does not seem to enhance patients\' recovery. However, diagnosis and aetiology appear to be important factors leading to a response to the treatment. These findings bring novel insights into possible cortical plasticity changes in DoC patients given these differential results according to the subgroups of patients.
Patients received 2 mA tDCS or sham applied over the left prefrontal cortex for 4 weeks. Behavioural assessments were performed weekly and up to 3 months\' follow-up. Analyses were conducted at the group and subgroup levels based on the diagnosis (minimally conscious state [MCS] and unresponsive wakefulness syndrome) and the aetiology (traumatic or non-traumatic). Interim analyses were planned to continue or stop the trial.
The trial was stopped for futility when 62 patients from 10 centres were enrolled (44 ± 14 years, 37 ± 24.5 weeks post-injury, 18 women, 32 MCS, 39 non-traumatic). Whilst, at the group level, no treatment effect was found, the subgroup analyses at 3 months\' follow-up revealed a significant improvement for patients in MCS and with traumatic aetiology.
Transcranial direct current stimulation during rehabilitation does not seem to enhance patients\' recovery. However, diagnosis and aetiology appear to be important factors leading to a response to the treatment. These findings bring novel insights into possible cortical plasticity changes in DoC patients given these differential results according to the subgroups of patients.
摘要：
目的：经颅直流电刺激（tDCS）已被证明可以改善意识障碍（DoC）患者的意识体征。然而,没有多中心研究证实其在康复期间应用时的有效性。在这项随机对照双盲研究中，在组水平上并根据患者的诊断和病因对患者康复期间tDCS的影响进行了测试，以更好地针对可能接受tDCS的DoC患者。
方法：患者接受2mAtDCS或在左前额叶皮层上应用假手术4周。每周进行行为评估，随访3个月。根据诊断（最低意识状态[MCS]和反应迟钝的觉醒综合征）和病因（创伤性或非创伤性）在组和亚组水平进行分析。中期分析计划继续或停止试验。
结果：当来自10个中心的62名患者入组时，该试验因无效而停止（44±14年，受伤后37±24.5周，18个女人,32MCS,39非创伤性）。同时,在集团层面,没有发现治疗效果，随访3个月时的亚组分析显示,MCS患者和外伤性病因患者有显著改善.
结论：康复期间的经颅直流电刺激似乎不能促进患者的康复。然而,诊断和病因似乎是导致治疗反应的重要因素。这些发现为DoC患者可能的皮质可塑性变化带来了新的见解，根据患者的亚组给出了这些差异结果。
方法：患者接受2mAtDCS或在左前额叶皮层上应用假手术4周。每周进行行为评估，随访3个月。根据诊断（最低意识状态[MCS]和反应迟钝的觉醒综合征）和病因（创伤性或非创伤性）在组和亚组水平进行分析。中期分析计划继续或停止试验。
结果：当来自10个中心的62名患者入组时，该试验因无效而停止（44±14年，受伤后37±24.5周，18个女人,32MCS,39非创伤性）。同时,在集团层面,没有发现治疗效果，随访3个月时的亚组分析显示,MCS患者和外伤性病因患者有显著改善.
结论：康复期间的经颅直流电刺激似乎不能促进患者的康复。然而,诊断和病因似乎是导致治疗反应的重要因素。这些发现为DoC患者可能的皮质可塑性变化带来了新的见解，根据患者的亚组给出了这些差异结果。
