Related Experiment Video
Updated: Jul 19, 2025
Enhancing the Development and Growth of Infant Cerebral Palsy Rats Using Selective Spinal Manipulations
Published on: February 2, 2024
sPinal cOrd neUromodulatioN to treat Cerebral palsy in pEdiatrics: POUNCE Multisite Randomized Clinical Trial
Kristin Girshin1,2, Rahul Sachdeva2,3, Richard Cohn4
1GirshinPT, Rancho Cucamonga, CA, United States.
Insights
This study investigates spinal cord neuromodulation (SCiP™) combined with activity-based neurorehabilitation therapy (ABNT) for children with cerebral palsy (CP). The trial aims to improve sensorimotor function and assess safety and efficacy.
Area of Science:
- Neurology
- Pediatrics
- Rehabilitation Medicine
Background:
- Cerebral palsy (CP) is the most common childhood motor disorder, affecting movement, balance, and posture.
- Current CP treatments focus on symptom management, often failing to address underlying neurological impairments.
- There is a need for novel therapies to improve sensorimotor function in children with CP.
Purpose of the Study:
- To evaluate the safety and efficacy of noninvasive spinal cord neuromodulation (SCiP™) combined with activity-based neurorehabilitation therapy (ABNT).
- To improve voluntary sensorimotor function in children diagnosed with cerebral palsy.
- To conduct a prospective, multicenter, double-blinded, sham-controlled, crossover, randomized control trial.
Main Methods:
- Sixty children (aged 2-13 years) with CP (Gross Motor Function Classification Scale Levels I-V) will be recruited.
- Participants will receive ABNT twice weekly for 16 weeks, with crossover in SCiP™ or sham stimulation for 8-week periods.
- Primary outcomes include the Gross Motor Function Measure-88 and Modified Ashworth Scale; safety will be assessed via adverse event monitoring.
Main Results:
- This section is to be filled once the trial results are available.
- The study is designed to provide robust data on the efficacy and safety of the intervention.
- Results will be disseminated through clinicaltrials.gov, publications, and conferences.
Conclusions:
- The findings from this trial are expected to inform future treatment strategies for cerebral palsy.
- This research may offer a new therapeutic approach to enhance sensorimotor function in children with CP.
- The study aims to contribute significant evidence regarding the benefits of SCiP™ combined with ABNT.
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.
