Supplement to TRANScranial direct current stimulation for POst-stroke motor Recover - a phase II sTudy (TRANSPORT 2)

摘要 中风仍然是致残的主要原因，运动障碍是最常见的 卒中后并发症。经颅直流电刺激--一种非侵入性脑刺激 刺激技术已被证明可以促进和增强大脑的可塑性，并调节 中风后出现的兴奋性和抑制性大脑半球间的失衡。 经颅直流电刺激促进卒中后运动功能恢复的II期研究 (TRANSPORT 2)是美国国立卫生研究院卒中网正在进行的一项多中心中风恢复研究。这个 这项建议的主要目的是确定是否有总体治疗效果 3个剂量组(假手术+mCIMT、2 mA+mCIMT和4 mA+mCIMT)于术后即刻给药。 每周干预Fugl-Myer上肢功能评分(运动障碍的衡量标准)。 其他结果测量包括Wolf运动功能测试时间分数(Wolf运动功能测试时间分数 功能性运动活动)，以及卒中影响量表手子量表(质量的衡量标准 生活)。持续受益在干预后1个月和3个月进行评估。 次级目标将评估安全性、耐受性和实施这一组合的可行性 在一项多点试验中采用这种方法。一个探索性的目标将检查加权的皮质脊髓束- 损伤负荷(WCST-LL，下行运动束完整性的结构评估)或运动 诱发电位(MEP，下行运动束完整性的功能评估)或a 两者的结合与FM-UE量表的变化相关，并评估这些工具的效用 作为未来验证性第三阶段研究中患者选择标准的生物标记物的测量。这个 研究正在进行中，是其资助期的最后一年。招聘人数已经达到了近75%。 然而，由于StrokeNet在Covid19期间关闭了3个月，随后速度慢于 预计网站重新激活，我们预计完成科目注册与现有的资金。这个非- 竞争性的行政补充是提供额外的费用来支付登记对象的 本研究的随访和数据分析阶段。

Abstract Stroke remains a leading cause of disability with motor deficit being the most common complication after stroke. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, has been shown to promote and enhance brain plasticity and to modulate the excitatory and inhibitory interhemispheric imbalance that developed after a stroke. TRANScranial direct current stimulation for POst-stroke motor Recovery - a phase II sTudy (TRANSPORT 2) is an ongoing multi-center stroke recovery study on the NIH StrokeNet. The primary aim of this proposal is to determine whether there is an overall treatment effect among the three dosing groups (sham+mCIMT, 2 mA+mCIMT and 4 mA+mCIMT) immediately after 2- week intervention in the Fugl-Myer Upper-Extremity Scale (a measure of motor impairment). Additional outcome measures include the Wolf Motor Function Test Time Score (a measure of functional motor activity), and the Stroke Impact Scale Hand Subscale (a measure of the quality of life). The sustained benefit is assessed at 1 month as well as 3 months post-intervention. Secondary aims will assess safety, tolerability, and feasibility to implement this combined approach in a multi-site trial. An exploratory aim will examine whether weighted corticospinal tract- lesion load (wCST-LL, structural assessment of integrity of descending motor tract) or Motor Evoked Potentials (MEPs, functional assessment of integrity of descending motor tract) or a combination of both are correlated with changes in FM-UE scale, and evaluate the utility of these measures as biomarkers for patient selection criteria in future confirmatory Phase III study. The study is ongoing and is its final year of funding period. The recruitment has reached nearly 75%. However, due to a 3-month shutdown of StrokeNet during Covid19 and subsequent slow-than- expected site reactivation, we project to finish subject enrollment with existing funding. This non- competing administrative supplement is to provide additional cost to cover the enrolled subjects' follow-up and data analysis period for this study.