Transcranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, we developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, we investigated brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients. Twenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; who received the real tDCS + iTBS output) group or a sham NIBS (who received sham tDCS + iTBS output) group. All subjects underwent 18 treatment sessions of 1 h of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT). Both groups showed improvements in FMA-UE, JTT, and FNT scores after the 6-week rehabilitation program. Notably, the real NIBS group had greater improvements in the JTT (p = 0. 016) and FNT (p = 0. 037) scores than the sham NIBS group, as determined by the Mann–Whitney rank-sum test. Patients who underwent the combined ipsilesional tDCS-iTBS stimulation with conventional rehabilitation exhibited greater impacts than did patients who underwent sham stimulation-conventional rehabilitation in statistically significant clinical responses of the total JTT time and FNT after the stroke. Preliminary results of upper-limb functional recovery suggest that tDCS-iTBS combined with a conventional rehabilitation intervention may be a promising strategy to enhance therapeutic benefits in future clinical settings. Trial registration: ClinicalTrials.gov Identifier: NCT04369235. Registered on 30 April 2020.

中文翻译：

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具有特殊波形的经颅电刺激可增强慢性卒中患者的上肢运动功能：一项初步随机对照试验

经颅直流电刺激 (tDCS) 和间歇性 theta 脉冲刺激 (iTBS) 均被证明具有治疗潜力，可在各种康复训练方案中快速诱导神经塑性效应。最近，我们开发了一种新颖的经颅电刺激装置，可以灵活地输出具有组合 tDCS 和 iTBS 波形的电流。然而，有限的研究已经确定了这种特殊波形组合对临床康复的治疗效果。在此，我们研究了 tDCS-iTBS 对慢性中风患者上肢运动功能的脑刺激作用。24 名患有慢性中风的受试者被随机分配到真正的非侵入性脑刺激 (NIBS；谁接受了真正的 tDCS + iTBS 输出）组或假 NIBS（谁接受了假 tDCS + iTBS 输出）组。所有受试者都接受了 18 次为期 1 小时的常规康复计划（每周 3 天，持续 6 周）的治疗，其中在常规康复过程中同时进行了 20 分钟的 NIBS 干预。在干预期之前和之后立即评估结果测量：Fugl-Meyer 评估-上肢 (FMA-UE)、捷成-泰勒手功能测试 (JTT) 和指鼻测试 (FNT)。在为期 6 周的康复计划后，两组的 FMA-UE、JTT 和 FNT 评分均有所改善。值得注意的是，真 NIBS 组在 JTT (p = 0. 016) 和 FNT (p = 0. 037) 分数方面比假 NIBS 组有更大的改进，这由 Mann-Whitney 秩和检验确定。在中风后总 JTT 时间和 FNT 的统计学显着临床反应方面，接受同侧 tDCS-iTBS 刺激与常规康复相结合的患者比接受假刺激 - 常规康复的患者表现出更大的影响。上肢功能恢复的初步结果表明，tDCS-iTBS 与常规康复干预相结合可能是在未来临床环境中增强治疗效果的一种有前景的策略。试验注册：ClinicalTrials.gov 标识符：NCT04369235。2020 年 4 月 30 日注册。