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: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658117
• 关键词: Acceleration; Advanced Development; Affect; Anodes; Bilateral; Blinded; Brain; Chronic; Clinical; Clinical Trials; Combined Modality Therapy; Contralateral; Cross-Over Studies; Dose; Electric Stimulation; Electric Stimulation Therapy; Electrodes; Extensor; FPS-FES Oncogene; Fingers; Hand; Hand functions; Hemiplegia; Impairment; Innovative Therapy; Intention; Intervention; Learning; Methods; Modality; Modeling; Motor; Motor Cortex; Movement; Muscle; Neuronal Plasticity; Neurons; Occupational Therapy; Outcome; Output; Paresis; Participant; Patients; Peripheral Nerve Stimulation; Persons; Randomized; Randomized, Controlled Trials; Rehabilitation Outcome; Rehabilitation therapy; Research; Research Personnel; Stroke; Surface; Testing; Therapeutic Effect; Thumb structure; United States; Upper Extremity; Work; aged; balance recovery; chronic stroke; clinically relevant; constraint induced movement therapy; dexterity; disability; follow-up; functional electrical stimulation; functional improvement; hand rehabilitation; hemiparesis; improved; improved outcome; instrument; motor recovery; neuromuscular stimulation; neurophysiology; noninvasive brain stimulation; novel; novel therapeutics; patient population; post stroke; robot assistance; stroke survivor; synergism; therapy development; transcranial direct current stimulation; upper limb hemiparesis

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.

项目概要/摘要 上肢偏瘫是中风引起的最严重的损伤之一。手指麻痹 拇指伸肌是中风的常见持续后果，并导致手部功能丧失。我们 开发了对侧控制功能性电刺激（CCFES），一种新型神经肌肉刺激 电刺激 (NMES) 疗法使患者能够密切控制刺激的时间和强度 刺激他们的手指和拇指伸肌，从而实现意图驱动的手张开和增强 功能性任务练习。 CCFES 辅助治疗的多项临床试验表明，它可以减少损伤 并改善受影响上肢的功能，并且比传统的 NMES 更能提高灵活性。这 本研究的主要目的是利用 CCFES 辅助治疗对慢性中风运动的益处 恢复。改善康复结果的一种策略是结合可能具有协同作用的治疗方法 影响。因此，本研究将经颅直流电刺激（tDCS）应用于运动皮层 CCFES 以确定两者的结合是否会比单独使用 CCFES 所取得的结果有所改善。 TDCS 和 CCFES 可以协同作用，通过增加皮质的并发活动来改善结果 同侧运动网络内的神经元（传统 tDCS 蒙太奇）或通过刺激对侧运动网络内的神经元 正如我们的试点单会话交叉研究所建议的那样，网络（非常规 tDCS 蒙太奇）。这 该研究的具体目标是： 1) 确定在 CCFES 期间添加 tDCS 是否可以改善运动结果 单独使用 CCFES，2) 估计两种 tDCS 电极布置对运动结果的相对影响， 3) 估计两种 tDCS 电极布置对神经生理学结果的相对影响。我们将 进行一项随机对照试验，其中 63 名中风后 6 至 24 个月的幸存者将被随机分组 分配至 12 周：a) CCFES 期间的传统 tDCS，b) CCFES 期间的非常规 tDCS，或 c) CCFES 期间假 tDCS。 上肢损伤、活动限制和神经生理学评估将 在基线、第 6、12、24 和 36 周进行。本研究是第一个在慢性病患者 CCFES 期间进行 tDCS 的随机对照试验。 上肢偏瘫。本研究中学到的信息将有助于加速开发 减少中风后残疾的治疗方法。