Spinal Cord Stimulation to Improve Motor Function in People with Post-Stroke Hemiplegia

脊髓刺激可改善中风后偏瘫患者的运动功能

基本信息

批准号：
10696255
负责人：
Marco Capogrosso
金额：
$ 157.08万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-08 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10696255
关键词：
Activities of Daily Living Affect American Animal Model Articular Range of Motion Authorization documentation Axon Behavior Therapy Behavioral Brain Cervical Cervical spinal cord structure Cervical spine Chronic Clinical Clinical Trials Clinical assessments Collaborations Data Devices Electroencephalography Feasibility Studies Fiber Forearm Goals H-Reflex Hand Hemiplegia Home Human Implant Implantation procedure Individual Industrialization Institutional Review Boards Intervention Joints Label Lateral Leg Lesion Link Locomotion Measures Motivation Motor Motor Neurons Movement Neurostimulation procedures of spinal cord tissue Operative Surgical Procedures Pain Paralysed Paresis Patients Performance Persons Phase Physical therapy Physiologic pulse Quality of life Randomized Residual state Sensory Spinal Spinal Cord Spinal cord injury Stroke Support System System Testing Therapeutic Time Torque Training Validation Vertebral column Weight-Bearing state With laterality Work arm arm function authority chronic stroke comparative efficacy design dexterity efficacy evaluation efficacy study efficacy testing grasp hemiparesis human data human subject implantation improved long term recovery motor control motor deficit motor function improvement motor impairment motor recovery neuroregulation novel off-label use post stroke preclinical study primary outcome prospective recruit safety testing secondary outcome social statistics stroke hemiparesis stroke rehabilitation stroke survivor synergism targeted treatment white matter damage

项目摘要

SUMMARY Motivation: In the US, almost 800’000 people have a stroke every year. Unfortunately, despite intense physio- therapy stroke survivors retain permanent arm motor deficits, some complete hemiparesis. Project Goal: Here we aim at testing the efficacy of a system delivering electrical neurostimulation to the cervi- cal spinal cord (SCS) to improve arm and hand motor control in people with chronic post-stroke hemiparesis Hypothesis: SCS of the lumbosacral circuits below the lesion immediately restored leg movements and weight bearing locomotion in humans with spinal cord injury by increasing strength and function. Moreover, SCS com- bined to physical therapy led to long-term improvements that improved motor control even when the stimulation was turned off. In stroke the spinal circuits controlling arm and hand movements are intact and located below the brain lesion. Therefore, we hypothesize that SCS targeting the cervical spinal cord will enable people with post-stroke hemiparesis to produce functional arm and hand movements, and that these improvements will en- able the administration of a tailored behavioral training leading to superior long-term motor recovery. Preliminary data: We implanted a human subject with post-stroke hemiparesis with lateral cervical spinal leads and showed that SCS substantially improved, strength at every joint of the arm and hand, range of motions, dexterity, clinical assessment scales (Fugl-Meyer +13) and functional abilities. Moreover, SCS did not induce pain or discomfort at intensities that were necessary to obtain motor improvements. Finally, our industrial partner (CorTec GmbH), is finalizing the tests to obtain IDE approval of a fully implantable pulse generator tailored to SCS of the cervical spinal cord. Approach: In the UG3 phase of our proposal (years 1 to 3) we will finalize the necessary validation on our implantable cervical stimulator to obtain IDE approval. In parallel we will perform a pilot 30 days trial with con- ventional clinical leads used off-label in subjects with stroke to optimize SCS implant procedures and SCS pa- rameters for maximization of arm functional movements. Finally, in the last 2 years during the UH3 phase we will execute an early feasibility study testing the efficacy of cervical SCS in combination with 4 weeks of physical therapy to improve arm motor control in up to 20 subjects with chronic post-stroke hemiparesis. Perspective: Our clinical trial will be the first to assess the efficacy of neurostimulation therapies targeting the spinal cord in patients with severe hemiparesis, potentially leading to a paradigm-shift in stroke rehabilitation. 1

概括动机：在美国，尽管进行了剧烈的运动，但不幸的是，每年仍有近 80 万人中风。中风治疗的幸存者保留永久性的手臂运动缺陷，有些人完全偏瘫。项目目标：我们的目标是测试向宫颈提供电神经刺激的系统的功效脊髓 (SCS) 可改善慢性中风后偏瘫患者的手臂和手部运动控制假设：病变下方腰骶回路的 SCS 立即恢复腿部运动和体重此外，SCS 还可以通过增强脊髓损伤的人的力量和功能来提高其运动能力。与物理治疗相结合带来了长期的改善，即使在刺激时也能改善运动控制中风时，控制手臂和手部运动的脊髓回路完好无损，位于下方。因此，我们认为针对颈脊髓的 SCS 将使患有脑损伤的患者受益。中风后偏瘫以产生功能性手臂和手部运动，这些改进将有助于能够进行量身定制的行为训练，从而实现卓越的长期运动恢复。初步数据：我们为一名中风后偏瘫患者植入了侧颈椎引线并表明 SCS 显着改善，手臂和手的每个关节的力量、运动范围、此外，SCS 并未诱导灵活性、临床评估量表 (Fugl-Meyer +13) 和功能能力。最后是我们的工业合作伙伴。（CorTec GmbH）正在完成测试，以获得针对完全植入式脉冲发生器的 IDE 批准。颈脊髓的 SCS。方法：在我们提案的 UG3 阶段（第 1 至第 3 年），我们将完成对我们的植入式宫颈刺激器以获得 IDE 批准同时，我们将进行为期 30 天的试点试验。在中风受试者中超说明书使用常规临床导线以优化 SCS 植入程序和 SCS pa 最后，在过去 2 年的 UH3 阶段，我们确定了手臂功能运动最大化的参数。将执行一项早期可行性研究，测试颈椎 SCS 与 4 周物理治疗相结合的功效该疗法可改善多达 20 名患有慢性中风后偏瘫的受试者的手臂运动控制。观点：我们的临床试验将是第一个评估针对神经刺激疗法的疗效的临床试验。严重偏瘫患者的脊髓，可能导致中风康复的范式转变。 1

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Supraspinal control of motoneurons after paralysis enabled by spinal cord stimulation.

通过脊髓刺激实现瘫痪后运动神经元的脊髓上控制。

DOI：
10.21203/rs.3.rs-3650257/v1
发表时间：
2024
期刊：
Research square
影响因子：
0
作者：
Capogrosso,Marco;Balaguer,Josep-Maria;Prat-Ortega,Genis;Verma,Nikhil;Yadav,Prakarsh;Sorensen,Erynn;deFreitas,Roberto;Ensel,Scott;Borda,Luigi;Donadio,Serena;Liang,Lucy;Ho,Jonathan;Damiani,Arianna;Grigsby,Erinn;Fields,Daryl;Go
通讯作者：
Go

Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis.

DOI：
10.1038/s41591-022-02202-6
发表时间：
2023-03
期刊：
NATURE MEDICINE
影响因子：
82.9
作者：
Powell, Marc P. P.;Verma, Nikhil;Sorensen, Erynn;Carranza, Erick;Boos, Amy;Fields, Daryl P. P.;Roy, Souvik;Ensel, Scott;Barra, Beatrice;Balzer, Jeffrey;Goldsmith, Jeff;Friedlander, Robert M. M.;Wittenberg, George F. F.;Fisher, Lee E. E.;Krakauer, John W. W.;Gerszten, Peter C. C.;Pirondini, Elvira;Weber, Douglas J. J.;Capogrosso, Marco
通讯作者：
Capogrosso, Marco

Feasibility and Validation of a Robotic-Based Multisensory Integration Assessment in Healthy Controls and a Stroke Patient.

基于机器人的多感官整合评估在健康对照和中风患者中的可行性和验证。

DOI：
10.1109/icorr58425.2023.10304735
发表时间：
2023
期刊：
IEEE ... International Conference on Rehabilitation Robotics : [proceedings]
影响因子：
0
作者：
Carranza,Erick;Bertoni,Tommaso;Mastria,Giulio;Boos,Amy;Bassolino,Michela;Serino,Andrea;Pirondini,Elvira
通讯作者：
Pirondini,Elvira

Poststroke arm and hand paresis: should we target the cervical spinal cord?

中风后手臂和手部麻痹：我们应该针对颈脊髓吗？

DOI：
10.1016/j.tins.2022.05.002
发表时间：
2022
期刊：
Trends in neurosciences
影响因子：
15.9
作者：
Pirondini,Elvira;Carranza,Erick;Balaguer,Josep-Maria;Sorensen,Erynn;Weber,DouglasJ;Krakauer,JohnW;Capogrosso,Marco
通讯作者：
Capogrosso,Marco