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.

项目摘要/摘要 上肢轻瘫是中风导致的最严重的损伤之一。手指轻瘫 和拇指伸肌是中风的一个经常持续的后果，并导致手功能的丧失。我们 已经开发出对侧控制功能性电刺激（CCFES），一种新的神经肌肉 电刺激（NMES）治疗，使患者能够密切控制电刺激的时间和强度。 刺激他们的手指和拇指伸肌，从而使意图驱动的手打开和增强 功能性任务实践。几项CCFES辅助治疗的临床试验表明， 并且改善了受影响上肢的功能，并且比传统的NMES更能改善灵活性。的 本研究的主要目的是建立CCFES辅助治疗慢性运动性卒中的益处 复苏改善康复结果的一种策略是将可能具有协同作用的联合收割机治疗与可能具有协同作用的其他治疗相结合。 方面的影响.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改善CCFES单独实现的结果。 TDCS和CCFES可以协同工作，通过增加皮质的同时活动来改善结果。 同侧运动网络内的神经元（常规tDCS蒙太奇）或通过刺激对侧运动网络， 网络（非常规tDCS蒙太奇），正如我们的试点单会话交叉研究所建议的那样。的 本研究的具体目的是：1）确定在CCFES期间添加tDCS是否改善运动结果 2）估计两种tDCS电极布置对运动结果的相对影响， 和3）估计两种tDCS电极布置对神经生理结果的相对影响。我们将 进行一项随机对照试验，将63名卒中后6至24个月的卒中幸存者随机 分配至12周：a）CCFES期间的常规tDCS，B）CCFES期间的非常规tDCS，或c） CCFES期间的假tDCS。 上肢损伤、活动受限和神经生理评估将 在基线、第6、12、24和36周进行。本研究是慢性心力衰竭患者CCFES期间tDCS的首个RCT。 上肢偏瘫本研究中了解到的信息将有助于加快 减少中风后残疾的治疗方法。