Spinal Cord Innovation in Pediatrics to Treat Cerebral Palsy (SCiP Clinical Study)

儿科脊髓创新治疗脑瘫（SCiP 临床研究）

• 批准号: 10760810
• 负责人: Parag Gad
• 金额: $ 92.46万
• 依托单位: SPINEX, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10760810
• 关键词: 21 year old; Address; Adult; Affect; Age; Agreement; Botulinum Toxin Type A; Brain; Breakthrough device; Cardiovascular system; Caring; Cerebral Palsy; Child; Childhood; Classification; Clinical; Clinical Research; Communication; Development; Devices; Diagnosis; Double-Blind Method; Epilepsy; Equilibrium; Esthesia; Etiology; Feedback; Functional disorder; Future; Impaired cognition; Impairment; Individual; International; Intervention; Intramuscular Injections; Life; Maintenance; Measures; Motor; Motor Activity; Movement; Muscle; Muscle function; Musculoskeletal; Nervous System Physiology; Neurogenic Bladder; Neurologic; Operative Surgical Procedures; Outcome; Pain; Pain management; Parents; Pathway interactions; Pediatrics; Perception; Persons; Pharmaceutical Preparations; Physical therapy; Physiological; Pilot Projects; Population Study; Posture; Prevalence; Procedures; Proprioception; Quality of life; Randomized, Controlled Trials; Reporting; Rhizotomy procedure; Risk; Safety; Sample Size; Sensorimotor functions; Severities; Spastic Cerebral Palsy; Spinal; Spinal Cord; Spinal cord injury; Statistical Data Interpretation; Symptoms; Testing; Therapeutic; Time; Update; Vertebral column; aged; clinically significant; design; disability; follow-up; functional electrical stimulation; functional improvement; improved; information processing; innovation; meetings; neural; neural circuit; neural network; neurological rehabilitation; neuromuscular plasticity; neuromuscular system; neuroregulation; novel therapeutics; pilot trial; primary outcome; prospective; recruit; rehabilitation strategy; response; secondary outcome; sensory input; skills; spasticity; spinal nerve posterior root; standard of care; symptom management; therapy design; transcutaneous stimulation; usability

Summary Cerebral Palsy (CP) is the most common motor disability in childhood. Population-based studies from around the world report prevalence estimates ranging from 1.5 to 4 per 1000 individuals. Globally, approximately 17 million people have CP. It is a diagnosis that includes a wide range of symptoms with heterogeneous etiologies of neural and cardiovascular origins. A wide range of functional disorders typically become obvious in CP during early development. For example, the majority of children classified as Gross Motor Functional Classification Scale (GMFCS) Level I are expected to reach their motor potential between 7-9 years and remain stable after that until age 21 where they may decline due to pain, weakness and stiffness. While movements such as stepping and posture are amongst the most recognizable impairments, absence or abnormal sensations, perception, impaired cognition, communication skills, epilepsy, spasticity, poor control of fine movements and marked secondary musculoskeletal problems can emerge with time. Presently, all available interventions are designed to minimize the severity of symptoms rather than correcting the neurological etiology. Two commonly preferred treatments, selective dorsal root rhizotomy and repetitive administration of botulinum toxin A (Botox) directly target the neuromuscular system to counter spasticity. While these two strategies minimize some of the disruptive movements associated with spasticity; the long-term benefits of these interventions are less clear and both cause irreversible changes to the neuromuscular system that may be detrimental to future function. In the present proposal we have merged ideas and concepts derived from both recent clinical observations of CP and decades of studies of spinal cord injury to arrive at a subject-specific rehabilitation strategy driven by activity- based mechanisms during transcutaneous spinal neuromodulation. The objectives of our neuromodulation procedures are to amplify the plasticity of the neuromuscular system and help children gain the ability to perform coordinated movements through activity-dependent plasticity. We hypothesized that transcutaneous spinal neuromodulation during activity-based neurorehabilitation therapy (ABNT) can transform the neural networks in children diagnosed with spastic CP to improve voluntary postural and locomotor activity as captured on the GMFM88 scores. This strategy could provide a specific physiological target of fundamental significance in the control of movement that can be used to improve function and provide new care pathways for children with CP.

概括 脑瘫（CP）是儿童期最常见的运动障碍。基于人群的研究 全球报告估计估计为每1000个人1.5至4个。全球，大约17 百万人有CP。这是一种诊断，包括多种症状，具有异质性病因 神经和心血管起源。在CP中，多种功能障碍通常在CP中变得明显 早期发展。例如，大多数被归类为总运动功能分类的儿童 比例尺（GMFC）I级I应在7 - 9年之间达到其电动机电位，并在此之后保持稳定 直到21岁，由于疼痛，无力和僵硬，他们可能会下降。而诸如步进之类的动作 和姿势是最知名的障碍，缺席或异常感觉，感知， 认知障碍，沟通技巧，癫痫，痉挛，痉挛，对精细运动的控制不良，并标记 次生肌肉骨骼问题会随着时间而出现。目前，所有可用的干预措施均已设计 为了最大程度地减少症状的严重程度，而不是纠正神经病学。两个通常首选 直接治疗，选择性背根茎切开术和重复给药肉毒杆菌毒素A（肉毒杆菌毒素） 靶向神经肌肉系统以应对痉挛。而这两种策略最大程度地减少了一些 与痉挛有关的破坏运动；这些干预措施的长期益处还不太清楚，并且 两者都会导致神经肌肉系统的不可逆转变化，这可能对未来功能有害。在 目前的建议我们合并了来自CP的最新临床观察结果和概念 数十年来的脊髓损伤研究得出了由活动驱动的特定主题的康复策略。 经经皮脊柱神经调节过程中的基于机制。我们神经调节的目标 程序是要扩大神经肌肉系统的可塑性，并帮助儿童获得表演的能力 通过活动依赖性可塑性的协调运动。我们假设经皮脊柱 基于活性的神经康复治疗（ABNT）期间的神经调节可以改变神经网络 被诊断为痉挛性CP以改善自愿性姿势和运动活动的儿童 GMFM88分数。该策略可以提供具有基本意义的特定生理目标 控制运动的控制，可用于改善功能并为CP儿童提供新的护理途径。