ELECTRICAL STIMULATION OF PERIPHERAL NERVE REPAIR TO IMPROVE FUNCTIONAL RECOVERY

电刺激周围神经修复以改善功能恢复

• 批准号: 8581676
• 负责人: THOMAS H TUNG
• 金额: $ 19万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-05 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8581676
• 关键词: Animals; Architecture; Basic Science; Brachial plexus structure; Climacteric; Clinical; Clinical Trials; Clinical assessments; Conduct Clinical Trials; Denervation; Double-Blind Method; Elbow; Electric Stimulation; Evaluation; Expenditure; Fracture; Human; Impairment; Injury; Laboratories; Literature; Measures; Methods; Modality; Modification; Motor; Muscle; Muscle function; Nerve; Nerve Regeneration; Neuromuscular Junction; Occupations; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Peripheral Nerves; Peripheral nerve injury; Physical Examination; Placebo Control; Placebos; Qualifying; Quality of life; Reconstructive Surgical Procedures; Recovery; Recovery of Function; SF-36; Safety; Speed; Spinal cord injury; Stress; Therapeutic; Time; Translations; Upper Extremity; Work; authority; bone healing; disability; experience; follow-up; functional outcomes; improved; member; nerve injury; patient population; public health relevance; reconstruction; reinnervation; repaired; restoration; success; translational study

DESCRIPTION (provided by applicant): Electrical stimulation has been shown to enhance nerve regeneration and muscle reinnervation in animals and to have some efficacy in patients with spinal cord injury. Currently there is no method in clinical use to speed the rate of recovery after peripheral nerve injury, and electrical stimulation has not been previously studied for peripheral nerve injuries in humans. The objective of this study is to explore the ability of electrical stimulation to benefit the treatment of patients with brachial plexus injury. Our hypothesis is that treatment with electrical stimulation after autogenous peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period of denervation and improve muscle reinnervation and recovery, and quality of life in patients with brachial plexus injury. The specific aim is to conduct a double-blind placebo-controlled pilot clinical trial of the safety and efficacy of electrical stimulation in improving success following reconstructive surgery in patient with brachial plexus injuries of the upper extremity. This application represents the first translational study proposed to investigate the use of electrical stimulation as a treatment option for the management of peripheral nerve injury. Such an agent could improve outcomes and significantly reduce long-term disability related to nerve injuries. A faster recovery would also mean sooner return to work, or simply return to work where it might otherwise not be possible, with potentially significant reduction in expenditures related to work days lost or job loss. Collectively these factors could significantly reduce the huge societal and financial burden of these patients, as well as the overwhelming and life-changing psychoemotional and financial stress experienced by these patients. The PI and his team have extensive experience in the management of severe peripheral nerve injuries, especially those involving the brachial plexus, and have also contributed significantly to the basic science literature in the study of the enhancement of nerve regeneration. Members of this group are also authorities in the evaluation of upper extremity impairment and the conduct of clinical trials. Therefore they are uniquely qualified to perform the study proposed, investigate further modifications of therapy and patient population as appropriate, and ultimately deliver efficient translation of information between the laboratory and clinical settings.

描述（由申请人提供）：电刺激已被证明可增强动物的神经再生和肌肉神经再支配，并对脊髓损伤患者具有一定疗效。目前在临床上还没有一种方法可以加快康复速度 在周围神经损伤之后，并且电刺激以前没有被研究用于人类的周围神经损伤。本研究旨在探讨电刺激对臂丛神经损伤患者的治疗作用。我们的假设是，自体周围神经重建后的电刺激治疗将加速神经再生，减少失神经支配的时间，改善臂丛神经损伤患者的肌肉神经再支配和恢复，以及生活质量。的 具体目的是进行一项双盲安慰剂对照的初步临床试验， 电刺激对提高上肢臂丛神经损伤重建手术成功率的疗效。该应用程序代表了第一个提出的转化研究，以调查使用电刺激作为治疗选择 用于周围神经损伤的管理。这种药物可以改善结果，并显着减少与神经损伤相关的长期残疾。更快的复苏还意味着更快地恢复工作，或者只是恢复原本不可能恢复的工作，从而可能大幅减少与损失工作日或失业有关的支出。总的来说，这些因素可以显着减少这些患者的巨大社会和经济负担，以及这些患者所经历的压倒性和改变生活的心理情绪和经济压力。PI和他的团队在严重周围神经损伤的管理方面拥有丰富的经验，特别是那些涉及臂丛神经的损伤，并且还为神经再生增强研究的基础科学文献做出了重大贡献。该小组的成员也是上肢损伤评估和临床试验开展方面的权威。因此，他们具有唯一资格进行拟定研究，酌情研究治疗和患者人群的进一步修改，并最终在实验室和临床环境之间提供有效的信息翻译。