Girshin Kristin, Sachdeva Rahul, Cohn Richard, Gad Parag, Krassioukov Andrei V, Edgerton V Reggie
GirshinPT, Rancho Cucamonga, CA, United States.
SpineX Inc., Los Angeles, CA, United States.
Front Neurosci. 2023 Jul 26;17:1221809. doi: 10.3389/fnins.2023.1221809. eCollection 2023.
Cerebral palsy (CP) affects up to 4 children in 1,000 live births, making it the most common motor disorder in children. It impairs the child's ability to move voluntarily and maintain balance and posture, and results in a wide range of other functional disorders during early development impairments in various sensory modalities, e.g., vision, hearing ability and proprioception. Current standard of care therapy focuses on symptom management and does not mitigate the progression of many of these underlying neurological impairments. The goal of this trial is to conduct a prospective multicenter, double-blinded, sham-controlled, crossover, randomized control trial to demonstrate the safety and efficacy of noninvasive spinal cord neuromodulation (SCiP™, SpineX Inc.) in conjunction with activity-based neurorehabilitation therapy (ABNT) to improve voluntary sensorimotor function in children with cerebral palsy.
Sixty participants (aged 2-13 years) diagnosed with CP classified as Gross Motor Function Classification Scale Levels I-V will be recruited and divided equally into two groups (G1 and G2). Both groups will receive identical ABNT 2 days/wk. G1 will initially receive sham stimulation, whereas G2 will receive therapeutic SCiP™ therapy for 8 weeks. After 8 weeks, G1 will cross over and receive therapeutic SCiP™ therapy for 8 weeks, whereas G2 will continue to receive SCiP™ therapy for another 8 weeks, for a total of 16 weeks. Primary and secondary outcome measures will include Gross Motor Function Measure-88 and Modified Ashworth Scale, respectively. Frequency and severity of adverse events will be established by safety analyses.
The trial is registered on clinicaltrials.gov (NCT05720208). The results from this trial will be reported on clinicaltrials.gov, published in peer-reviewed journals and presented at scientific and clinical conferences.
脑性瘫痪（CP）在每1000例活产儿中影响多达4名儿童，使其成为儿童中最常见的运动障碍。它损害儿童自主运动和维持平衡及姿势的能力，并在早期发育过程中导致广泛的其他功能障碍，如各种感觉模态（例如视觉、听力和本体感觉）的损伤。当前的护理标准疗法侧重于症状管理，并未减轻许多这些潜在神经损伤的进展。本试验的目的是进行一项前瞻性多中心、双盲、假对照、交叉、随机对照试验，以证明非侵入性脊髓神经调节（SCiP™，SpineX公司）联合基于活动的神经康复治疗（ABNT）改善脑性瘫痪儿童自主感觉运动功能的安全性和有效性。
将招募60名被诊断为CP且分类为粗大运动功能分级量表I - V级的参与者（年龄2 - 13岁），并将其平均分为两组（G1和G2）。两组均每周接受2天相同的ABNT。G1最初将接受假刺激，而G2将接受8周的治疗性SCiP™疗法。8周后，G1将交叉并接受8周的治疗性SCiP™疗法，而G2将继续接受另外8周的SCiP™疗法，共计16周。主要和次要结局指标将分别包括粗大运动功能测量-88和改良Ashworth量表。不良事件的频率和严重程度将通过安全性分析确定。
该试验已在clinicaltrials.gov（NCT05720208）上注册。本试验的结果将在clinicaltrials.gov上报告，发表在同行评审期刊上，并在科学和临床会议上展示。
