Objective. Non-invasive brain stimulation has been promoted to facilitate neuromodulation in treating neurological diseases. Recently, high-definition (HD) transcranial electrical stimulation and a novel electrical waveform combining a direct current (DC) and theta burst stimulation (TBS)-like protocol were proposed and demonstrated high potential to enhance neuroplastic effects in a more-efficient manner. In this study, we designed a novel HD transcranial burst electrostimulation device and to preliminarily examined its therapeutic potential in neurorehabilitation. Approach. A prototype of the transcranial burst electrostimulation device was developed, which can flexibly output a waveform that combined a DC and TBS-like protocol and can equally distribute the current into 4 1 HD electrical stimulation by automatic impedance adjustments. The safety and accuracy of the device were then validated in a series of in vitro experiments. Finally, a pilot clinical trial was conducted to assess its clinical safety and therapeutic potential on upper-extremity rehabilitation in six patients with chronic stroke, where patients received either active or sham HD transcranial burst electrostimulation combined with occupational therapy three times per week for four weeks. Main results. The prototype was tested, and it was found to comply with all safety requirements. The output parameters were accurate and met the clinical study needs. The pilot clinical study demonstrated that the active HD transcranial burst electrostimulation group had greater improvement in voluntary motor function and coordination of the upper extremity than the sham control group. Additionally, no severe adverse events were noted, but slight skin redness under the stimulus electrode immediately after stimulation was seen. Conclusions. The results demonstrated the feasibility of incorporating the HD electrical DC and TBS-like protocol in our device; and the novel neuromodulatory device produced positive neurorehabilitation outcomes in a safe fashion, which could be the basis for the future clinical implementation for treating neurological diseases.

Trial registration: ClinicalTrials.gov Identifier: NCT04278105. Registered on 20 February 2020.

客观的。非侵入性脑刺激已被推广以促进神经调节治疗神经系统疾病。最近，提出了高清 (HD) 经颅电刺激和一种结合直流 (DC) 和θ脉冲刺激 (TBS) 样协议的新型电波形，并展示了以更有效的方式增强神经可塑性效应的高潜力。在本研究中，我们设计了一种新型 HD 经颅脉冲电刺激装置，并初步检验了其在神经康复中的治疗潜力。方法。研制了经颅脉冲电刺激装置样机，该装置可灵活输出结合DC和TBS类协议的波形，并可通过自动阻抗调节将电流均匀分配到4 1 HD电刺激中。然后在一系列体外实验中验证了该设备的安全性和准确性。最后，进行了一项试点临床试验，以评估其对六名慢性卒中患者上肢康复的临床安全性和治疗潜力，其中患者每周接受 3 次主动或假 HD 经颅脉冲电刺激联合职业治疗，持续 4 周. 主要结果。该原型经过测试，发现符合所有安全要求。输出参数准确，满足临床研究需要。初步临床研究表明，主动 HD 经颅脉冲电刺激组在自主运动功能和上肢协调性方面比假对照组有更大的改善。此外，没有注意到严重的不良事件，但在刺激后立即在刺激电极下看到轻微的皮肤发红。结论。结果证明了在我们的设备中加入 HD 电气 DC 和类 TBS 协议的可行性；并且新型神经调节装置以安全的方式产生了积极的神经康复结果，这可能成为未来临床实施治疗神经系统疾病的基础。

试验注册： ClinicalTrials.gov 标识符：NCT04278105。于 2020 年 2 月 20 日注册。