NCT05720208

Spinal Cord Innovation in Pediatrics (SCiP) to Treat SensoriMotor Function in Children Cerebral Palsy: Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: SpineX Inc. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Cerebral palsy affects up to 4 children in 1000 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 resultsing in a wide range of other functional disorders during early development that persist and frequently worsen with age including spasticity and often multiple abnormal sensationsensory modalities. Current standard of care treatments focus on symptom management and do 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 stimulation (using SCiPTM device, SpineX Inc.) in conjunction with activity-based neurorehabilitation therapy (ABNT) to improve voluntary sensorimotor function in children with cerebral palsy. 44 children participants (aged 2-18 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 SCiPTM therapy for 8 weeks. After 8 weeks, G1 will cross over and receive therapeutic SCiPTM therapy for 8 weeks, whereas G2 will continue to receive SCiPTM 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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	SCiP	Noninvasive Spinal Cord Neuromodulator

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2023-02-09
• Last updated: 2023-02-09