A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy.

A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy.
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DOI:
10.1038/s41467-022-33208-w
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发表时间:
2022-10-05
影响因子:
16.6
通讯作者:
--
中科院分区:
综合性期刊1区
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--
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脑性瘫痪(CP)是最常见的儿科运动障碍,具有多种症状和病因。CP表现为感觉运动延迟、姿势受损,导致活动和参与受限。我们最近结束的单臂、非盲、初步研究(NCT 04882592)探讨了在基于活动的神经康复治疗(ABNT)期间结合非侵入性脊神经调节的干预是否可以改善通过粗大运动功能测量(GMFM-88)评分(主要结局)捕获的自主感觉运动功能。招募了16名粗大运动功能分类量表I-V级诊断为CP的儿童,并接受了相同的干预(每周2次,持续8周),以使用正常发育的本体感觉纠正棘上和脊髓网络之间的功能障碍性连接。我们证明了干预与所有儿童的GMFM-88评分的临床和统计学显著改善相关,因此符合预先规定的主要终点。然而,单独使用ABNT的改善需要进一步探索。未观察到严重不良事件(安全性终点)。在这里,作者报告了一项单臂试点试验,旨在研究脊髓神经调节和基于活动的神经康复治疗对脑瘫儿童自主感觉运动功能的影响。
Cerebral Palsy (CP) is the most common pediatric motor disability with multiple symptoms and etiologies. CP is exhibited through sensorimotor delays, impaired posture resulting in limited activities and participation. Our recently concluded, single arm, unblinded, pilot study (NCT04882592) explored whether an intervention combining non-invasive spinal neuromodulation during an activity-based neurorehabilitation therapy (ABNT) can improve voluntary sensory-motor function captured via the Gross Motor Function Measure (GMFM-88) scores (primary outcome). Sixteen children diagnosed with CP with Gross Motor Function Classification Scale levels I-V were recruited and received the same intervention (2x/week for 8 weeks) to correct the dysfunctional connectivity between supraspinal and spinal networks using the normally developed proprioception. We demonstrate that the intervention was associated with clinically and statistically significant improvement in GMFM-88 scores in all children, thus meeting the prespecified primary endpoint. However, the improvement with ABNT alone needs further exploration. No serious adverse events were observed (safety endpoint). Here the authors report a single arm pilot trial to investigate combined spinal neuromodulation and activity-based neurorehabilitation therapy on voluntary sensory-motor function in children with cerebral palsy.
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