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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Arm | Experimental |
| |
| Sham Arm | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCiP | Device | Noninvasive Spinal Cord Neuromodulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMFM88 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Parag Gad, PhD | Contact | 408-203-5061 | info@spinex.co |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37564370 | Derived | Girshin K, Sachdeva R, Cohn R, Gad P, Krassioukov AV, Edgerton VR. sPinal cOrd neUromodulatioN to treat Cerebral palsy in pEdiatrics: POUNCE Multisite Randomized Clinical Trial. Front Neurosci. 2023 Jul 26;17:1221809. doi: 10.3389/fnins.2023.1221809. eCollection 2023. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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