ABSTRACT
Regaining motor function in individuals with cerebral palsy (CP) has been predominantly studied in children, resulting in an underrepresentation of adults in research efforts. We tested the efficacy of noninvasive spinal neuromodulation with neurorehabilitation (Spinal Cord Innovation in Pediatrics; SCiP™ therapy). A 60-year-old CP participant underwent 8 weeks of SCiP™ therapy, resulting in significant motor recovery measured by 14.2-points increase in gross motor function measure (GMFM-88) score, ~ three times the Minimal Clinically Important Difference (MCID) of 5-points. This represented gains in kneeling, sitting, and walking functions. The improvement in GMFM-88 score was maintained above the MCID at the follow up visit (10.3 points above the baseline), twenty weeks following the last therapy session, indicating a persistent effect of the therapy. Our preliminary findings support the therapeutic promise of SCiP™ therapy for enhancing motor function in CP adults. Broader investigations are needed to establish its wider applicability.
ABSTRACT
Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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.
ABSTRACT
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 (n = 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.
