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

• 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
• 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

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

总结

项目成果

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
• 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

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

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]
• 作者: Carranza,Erick;Bertoni,Tommaso;Mastria,Giulio;Boos,Amy;Bassolino,Michela;Serino,Andrea;Pirondini,Elvira
• 通讯作者: Pirondini,Elvira