Sachdeva Rahul, Girshin Kristin, Shirkhani Yousef, Gad Parag, Edgerton V Reggie
SpineX Inc., Los Angeles, CA, United States.
International Collaboration on Repair Discoveries (ICORD), Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
Front Rehabil Sci. 2023 Jul 26;4:1216281. doi: 10.3389/fresc.2023.1216281. eCollection 2023.
Motor dysfunction in individuals with cerebral palsy (CP) such as the inability to initiate voluntary movements, walking with compensatory movement patterns, and debilitating spasticity is due to the aberrant neural connectivity between the brain and spinal cord. We tested the efficacy of noninvasive spinal cord neuromodulation (SCiP™, SpineX Inc.) with activity-based neurorehabilitation therapy (ABNT) in improving the sensorimotor function in six children with CP. Children received 8 weeks of either SCiP™ or sham therapy with ABNT ( = 3 per group). At the end of 8 weeks, all participants received 8 weeks of SCiP™ therapy with ABNT. Follow up assessments were done at week 26 (10 weeks after the last therapy session). Sensorimotor function was measured by the Gross Motor Function Measure 88 (GMFM88) test. We observed minimal change in sham group (mean 6% improvement), however, eight weeks of SCiP™ therapy with ABNT resulted in statistically and clinically relevant improvement in GMFM88 scores (mean 23% increase from baseline). We also observed reduced scores on the modified Ashworth scale only with SCiP™ therapy (-11% vs. +5.53% with sham). Similar improvements were observed in sham group but only after the cross over to SCiP™ therapy group at the end of the first eight weeks. Finally, sixteen weeks of SCiP™ therapy with ABNT resulted in further improvement of GMFM88 score. The improvement in GMFM88 scores were maintained at week 26 (10 weeks after the end of therapy), suggesting a sustained effect of SCiP™ therapy.
脑瘫（CP）患者的运动功能障碍，如无法发起自主运动、以代偿性运动模式行走以及严重的痉挛，是由于大脑与脊髓之间异常的神经连接所致。我们测试了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）对6名脑瘫儿童感觉运动功能的改善效果。儿童接受了为期8周的SCiP™治疗或假治疗加ABNT（每组3人）。在8周结束时，所有参与者都接受了为期8周的SCiP™治疗加ABNT。在第26周（最后一次治疗 session 后10周）进行随访评估。感觉运动功能通过粗大运动功能测量88（GMFM88）测试进行测量。我们观察到假治疗组变化极小（平均改善6%），然而，为期8周的SCiP™治疗加ABNT使GMFM88评分在统计学和临床上都有显著改善（比基线平均提高23%）。我们还观察到仅在接受SCiP™治疗时改良Ashworth量表评分降低（-11%，假治疗组为+5.53%）。在假治疗组也观察到了类似的改善，但仅在最初八周结束时 crossover 到SCiP™治疗组之后。最后，为期16周的SCiP™治疗加ABNT使GMFM88评分进一步提高。GMFM88评分的改善在第26周（治疗结束后10周）得以维持，表明SCiP™治疗具有持续效果。
