Effectiveness and neural mechanisms associated with tDCS delivered to premotor cortex in stroke rehabilitation: study protocol for a randomized controlled trial.
Effectiveness and neural mechanisms associated with tDCS delivered to premotor cortex in stroke rehabilitation: study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-14-331
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发表时间：
2013-10-12
期刊：
影响因子：
2.5
通讯作者：
Machado A
中科院分区：
文献类型：
--
作者：
Plow EB;Cunningham DA;Beall E;Jones S;Wyant A;Bonnett C;Yue GH;Lowe M;Wang XF;Sakaie K;Machado A
超过60%的中风幸存者经历麻痹上肢/手的残余缺陷。标准的康复治疗效果不佳。刺激传递到中风影响的半球中幸存的初级运动皮层被认为是一种有前途的辅助手段。然而，最近的试验挑战了它的优势。我们讨论了我们的试点临床试验，旨在解决的方法不同的成功因素。我们评估了在康复过程中靶向替代位点-运动前区皮质的安全性、可行性和有效性。在预测患者之间的差异时，我们测量区分反应和无反应的神经标志物。在一项随机、假手术对照、双盲的初步临床研究中，慢性卒中患者（n = 20）被分配接受经颅直流电刺激，在瘫痪手臂/手的康复过程中输送到运动前区皮质或假手术。患者接受指定干预30 min，每周3 d，每日2次，共5周。我们评估手的功能和病人的报告使用麻痹的手。一般线性混合方法模型将分析干预前后的变化。将根据基线功能水平和神经基质（包括输出束的功能和完整性、双半球平衡和病变轮廓）比较应答者和非应答者。将使用Fisher精确检验比较不良事件的发生率，同时将使用卡方分析评估设盲的严格性以确定可行性。皮质刺激在康复中的不同成功可能与理论基础和临床研究的差距有关。考虑到大多数严重缺陷的患者的初级运动皮层或其输出通路受损，将刺激目标定位于该部位将是徒劳的。我们建议靶向运动前区皮层，因为它在很大程度上有助于降低输出，这一作用随着运动皮层的更大损伤而放大。关于临床研究，已将康复中的成对皮质刺激与非盲试验中的单独康复或不令人信服的假条件进行了比较。经颅直流电刺激是一种非侵入性的脑刺激技术，它提供了一种更有效的安慰剂，并具有良好的安全性和可行性，可能会提高科学的严谨性。反应的神经标志物将有助于为未来的临床试验提供患者选择信息，因此我们可以解决最近负面研究的局限性。NCT01539096
More than 60% of stroke survivors experience residual deficits of the paretic upper limb/hand. Standard rehabilitation generates modest gains. Stimulation delivered to the surviving Primary Motor Cortex in the stroke-affected hemisphere has been considered a promising adjunct. However, recent trials challenge its advantage. We discuss our pilot clinical trial that aims to address factors implicated in divergent success of the approach. We assess safety, feasibility and efficacy of targeting an alternate locus during rehabilitation- the premotor cortex. In anticipating variance across patients, we measure neural markers differentiating response from non-response. In a randomized, sham-controlled, double-blinded pilot clinical study, patients with chronic stroke (n = 20) are assigned to receive transcranial direct current stimulation delivered to the premotor cortex or sham during rehabilitation of the paretic arm/hand. Patients receive the designated intervention for 30 min, twice a day for 3 days a week for 5 weeks. We assess hand function and patients’ reports of use of paretic hand. A general linear mixed methods model will analyze changes from pre- to post-intervention. Responders and non-responders will be compared upon baseline level of function, and neural substrates, including function and integrity of output tracts, bi-hemispheric balance, and lesion profile. Incidence of adverse events will be compared using Fisher’s Exact test, while rigor of blinding will be assessed with Chi-square analysis to ascertain feasibility. Variable success of cortical stimulation in rehabilitation can be related to gaps in theoretical basis and clinical investigation. Given that most patients with severe deficits have damage to the primary motor cortex or its output pathways, it would be futile to target stimulation to this site. We suggest targeting premotor cortex because it contributes substantially to descending output, a role that is amplified with greater damage to the motor cortex. With regards to clinical investigation, paired cortical stimulation in rehabilitation has been compared to rehabilitation alone in unblinded trials or to unconvincing sham conditions. Transcranial direct current stimulation, a noninvasive technique of brain stimulation, which offers a more effective placebo and has a favorable safety-feasibility profile, may improve scientific rigor. Neural markers of response would help inform patient selection for future clinical trials so we can address limitations of recent negative studies. NCT01539096
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