Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: Study Protocol for a Pilot Randomized Clinical Trial.

Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: Study Protocol for a Pilot Randomized Clinical Trial.
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DOI:
10.1159/000521514
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发表时间:
2022
期刊:
Cerebrovascular diseases (Basel, Switzerland)
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其他
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高达50%的中风幸存者即使在接受康复治疗后仍有持续的严重上肢轻瘫。重复经颅磁刺激(rTMS)可以通过调节皮质运动兴奋性来增强康复的效果,但传统的促进同侧初级运动皮质(iM1)兴奋性的方法未能在卒中幸存者中产生运动改善。相反,未受损的,对侧背侧运动前皮质(cPMd)可能是一个更合适的目标。CPMd可以提供交替的、双半球的和同侧的连接,以支持麻痹肢体运动。这项试点随机临床试验旨在研究在严重受损的卒中幸存者中,与促进iM1结合康复的传统rTMS相比,促进cPMd结合康复的rTMS是否能产生更大的运动功能增益。将纳入24例具有严重病灶基质损失(定义为使用TMS测试的可兴奋残留通路的生理学证据缺失)的慢性(≥ 6个月)卒中幸存者。受试者将随机接受rTMS,以促进cPMd或iM1与任务导向的上肢康复,每周2次,持续6周。将在基线和6周治疗结束时评估与运动损伤(上肢Fugl-Meyer,UEFM)、运动功能、神经生理学和功能性神经影像学相关的主要结局。将在3个月随访时重复进行额外的运动结局评估,以评价保留情况。主要终点是UEFM的6周变化。这项初步试验将提供与促进慢性重度卒中幸存者的完整cPMd相关的作用和机制的初步证据。该试验在www.example.com上注册,NCT 03868410。
Up to 50% of stroke survivors have persistent, severe upper extremity paresis even after receiving rehabilitation. Repetitive transcranial magnetic stimulation (rTMS) can augment the effects of rehabilitation by modulating corticomotor excitability, but the conventional approach of facilitating excitability of the ipsilesional primary motor cortex (iM1) fails to produce motor improvement in stroke survivors with severe loss of ipsilesional substrate. Instead, the undamaged, contralesional dorsal premotor cortex (cPMd) may be a more suitable target. CPMd can offer alternate, bi-hemispheric and ipsilateral connections in support of paretic limb movement. This pilot, randomized clinical trial seeks to investigate whether rTMS delivered to facilitate cPMd in conjunction with rehabilitation produces greater gains in motor function than conventional rTMS delivered to facilitate iM1 in conjunction with rehabilitation in severely impaired stroke survivors. Twenty-four chronic (≥6 months) stroke survivors with severe loss of ipsilesional substrate (defined by the absence of physiologic evidence of excitable residual pathways tested using TMS) will be included. Participants will be randomized to receive rTMS to facilitate cPMd or iM1 in conjunction with task-oriented upper limb rehabilitation given for 2 sessions/week for 6 weeks. Assessments of primary outcome related to motor impairment (Upper Extremity Fugl-Meyer, UEFM), motor function, neurophysiology, and functional neuroimaging will be made at baseline and at 6-week end-of-treatment. An additional assessment of motor outcomes will be repeated at 3-month follow-up to evaluate retention. The primary endpoint is 6-week change in UEFM. This pilot trial will provide preliminary evidence on the effects and mechanisms associated with facilitating intact cPMd in chronic severe stroke survivors. The trial is registered on clinicaltrials.gov, NCT03868410.
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影响因子: --
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