Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy.
Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, University Campus Bio-Medico of Rome, Rome, Italy.
Neurorehabil Neural Repair. 2022 Dec;36(12):800-809. doi: 10.1177/15459683221138743.
To assess whether dual transcranial direct current stimulation (tDCS) may enhance the efficacy of exoskeleton robotic training on upper limb motor functions in patients with chronic stroke.
A prospective, bi-center, double-blind, randomized clinical trial study was performed. Patients with moderate-to-severe stroke (according to The National Institute of Health Stroke Scale) were randomly assigned to receive dual or sham tDCS immediately before robotic therapy (10 sessions, 2 weeks). The primary outcome was the Fugl-Meyer for Upper Extremity, assessed before, after, and at the 12-week follow-up. Neurophysiological evaluation of corticospinal projections to upper limb muscles was performed by recording motor evoked potentials (MEPs). ClinicalTrials.gov-NCT03026712.
Two hundred and sixty individuals were tested for eligibility, of which 80 were enrolled and agreed to participate. Excluding 14 dropouts, 66 patients were randomly assigned into the 2 groups. Results showed that chronic patients were stable before treatment and significantly improved after that. The records within subject improvements were not significantly different between the 2 groups. However, a post-hoc analysis subdividing patients in 2 subgroups based on the presence or absence of MEPs at the baseline showed a significantly higher effect of real tDCS in patients without MEPs when compared to patients with MEPs ( = 4.6, = .007).
The adjunction of dual tDCS to robotic arm training did not further enhance recovery in the treated sample of patients with chronic stroke. However, a significant improvement in the subgroup of patients with a severe corticospinal dysfunction (as suggested by the absence of MEPs) suggests that they could benefit from such a treatment combination.
评估双经颅直流电刺激(tDCS)是否可以增强外骨骼机器人训练对慢性脑卒中患者上肢运动功能的疗效。
进行了一项前瞻性、双中心、双盲、随机临床试验研究。将中度至重度脑卒中患者(根据国立卫生研究院脑卒中量表)随机分为两组,分别在机器人治疗前(共 10 次,2 周)接受双 tDCS 或假 tDCS。主要结局是使用上肢 Fugl-Meyer 评估,在治疗前、治疗后和 12 周随访时进行评估。通过记录运动诱发电位(MEPs)来评估皮质脊髓投射至上肢肌肉的神经生理学。ClinicalTrials.gov-NCT03026712。
共有 260 人符合纳入标准,其中 80 人被纳入并同意参加。排除 14 名脱落者后,共有 66 名患者被随机分为两组。结果表明,慢性患者在治疗前稳定,治疗后明显改善。两组患者的个体内改善记录无显著差异。然而,根据基线时是否存在 MEPs 将患者分为 2 个子组的事后分析显示,与有 MEPs 的患者相比,无 MEPs 的患者的真实 tDCS 效果明显更高( = 4.6, = .007)。
双 tDCS 联合机器人手臂训练并不能进一步增强慢性脑卒中患者治疗样本的恢复。然而,在皮质脊髓功能严重障碍(如 MEPs 缺失所提示)的亚组患者中,显著改善表明他们可能受益于这种治疗组合。