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tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
上肢偏瘫对侧控制 FES 期间的 tDCS
批准号:
10658117
负责人:
David Arthur Cunningham
金额:
$68.21万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-05-01 至 2028-04-30

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中文摘要
翻译
项目摘要/摘要 上肢偏瘫是中风引起的最严重的损伤之一。手指轻瘫 拇指伸肌是中风经常持续存在的后果,并导致手功能丧失。我们 已经开发出对侧控制功能电刺激(CCFES),这是一种新型的神经肌肉 电刺激(NMES)疗法,使患者能够亲密地控制时间和强度 刺激他们的手指和拇指伸肌,从而使意图驱动的手张开和增强 功能任务练习。几项CCFES辅助治疗的临床试验表明,它可以减少损伤 并改善患侧上肢的功能,比传统的NMES更能提高灵活性。这个 这项研究的主要目的是建立在CCFES辅助治疗慢性卒中运动的益处的基础上 恢复。改善康复效果的一个策略是结合可能具有协同作用的治疗。 效果。因此,本研究将经颅直流电刺激(Tdcs)应用于运动皮质。 以确定这两者的结合是否会比CCFES单独取得的成果更好。 TDCs和CCFES可能协同工作,通过增加大脑皮层的并行活动来改善预后 单侧运动神经网络内的神经元(传统的tdcs蒙太奇)或通过刺激对侧 网络(非常规tdcs蒙太奇),正如我们的试点单节交叉研究所建议的那样。这个 这项研究的具体目的是:1)确定在CCFES期间加入tDCs是否改善了运动结果 仅通过CCFES,2)估计两种tdcs电极布置对运动结果的相对影响。 3)评估两种tdcs电极布置对神经生理学结果的相对影响。我们会 进行一项随机对照试验,其中63名卒中幸存者在卒中后6至24个月内随机 分配给12周:a)CCFES期间的常规tDC,b)CCFES期间的非常规tDC,或c) CCFES期间的假tDC。 上肢功能障碍、活动受限和神经生理学评估 在基线、6周、12周、24周和36周进行。这项研究是首次在慢性肾功能衰竭患者的CCFES期间进行的TDCSRCT。 上肢偏瘫。从这项研究中了解到的信息将有助于加速 减少中风后残疾的治疗。
英文摘要
PROJECT SUMMARY / ABSTRACT Hemiparesis of the upper-limb is one of the most serious impairments resulting from stroke. Paresis of finger and thumb extensors is a frequently persisting consequence of stroke, and causes loss of hand function. We have developed contralaterally controlled functional electrical stimulation (CCFES), a novel neuromuscular electrical stimulation (NMES) therapy that gives the patient intimate control of both timing and intensity of stimulation to their finger and thumb extensors and thereby enables intention-driven hand opening and enhanced functional task practice. Several clinical trials of CCFES-assisted therapy have shown that it reduces impairment and improves function of the affected upper-limb, and it improves dexterity more than conventional NMES. The main objective of this study is to build upon the benefits of CCFES-assisted therapy for chronic stroke motor recovery. One strategy to improve rehabilitation outcomes is to combine treatments that may have synergistic effects. Therefore, this study applies transcranial direct current stimulation (tDCS) to the motor cortex during CCFES to determine if the combination of the two will improve outcomes over those achieved by CCFES alone. TDCS and CCFES may work in synergy to improve outcomes by increasing the concurrent activity of the cortical neurons within the ipsilesional motor network (conventional tDCS montage) or by exciting the contralesional networks (unconventional tDCS montage), as suggested by our pilot single-session cross-over study. The specific aims of the study are: 1) Determine if the addition of tDCS during CCFES improves motor outcomes over CCFES alone, 2) Estimate the relative effects of two tDCS electrode arrangements on motor outcomes, and 3) Estimate the relative effects of two tDCS electrode arrangements on neurophysiologic outcomes. We will conduct a randomized controlled trial in which 63 stroke survivors 6 to 24 months post-stroke will be randomly assigned to 12 weeks of: a) conventional tDCS during CCFES, b) unconventional tDCS during CCFES, or c) sham tDCS during CCFES. Upper extremity impairment, activity limitation and neurophysiologic assessment will be made at baseline, 6, 12, 24, and 36 weeks. This study is the first RCT of tDCS during CCFES in chronic upper extremity hemiplegia. The information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability.
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