sPinal cOrd neUromodulatioN to treat Cerebral palsy in pEdiatrics: POUNCE Multisite Randomized Clinical Trial

Frontiers in Neuroscience

Neuroscience

Kristin Girshin¹  Richard Cohn²  Andrei V. Krassioukov³  Parag Gad⁴  Rahul Sachdeva⁵  V. Reggie Edgerton⁶ 

[1] GirshinPT, Rancho Cucamonga, CA, United States;SpineX Inc., Los Angeles, CA, United States;Independent Consultant, Chapel Hill, NC, United States;International Collaboration on Repair Discoveries, Department of Medicine, University of British Columbia, Vancouver, BC, Canada;Spinal Cord Program, GF Strong Rehabilitation Centre, University of British Columbia, Vancouver, BC, Canada;SpineX Inc., Los Angeles, CA, United States;SpineX Inc., Los Angeles, CA, United States;International Collaboration on Repair Discoveries, Department of Medicine, University of British Columbia, Vancouver, BC, Canada;SpineX Inc., Los Angeles, CA, United States;Rancho Research Institute, Downey, CA, United States;USC Neurorestoration Center, University of Southern California, Los Angeles, CA, United States;Institut Guttmann, Hospital de Neurorehabilitació, Institut Universitari adscrit a la Universitat Autònoma de Barcelona, Badalona, Spain;

关键词: spinal cord neuromodulation;    noninvasive stimulation;    cerebral palsy;    sensorimotor function;    spasticity;   

DOI  :  10.3389/fnins.2023.1221809

 received in 2023-05-12, accepted in 2023-07-11,  发布年份 2023

来源: Frontiers

【 摘 要 】

IntroductionCerebral 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.Methods and analysisSixty 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.Ethics and disseminationThe 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.

【 授权许可】

Unknown   
Copyright © 2023 Girshin, Sachdeva, Cohn, Gad, Krassioukov and Edgerton.