SpineX, a bioelectric MedTech company, has released the findings of its first human trial of a non-invasive spinal electrical neuromodulation device — Spinal Cord Innovation in Pediatrics (SCiP) — for the treatment of children with cerebral palsy.
The study published in Nature Communications indicates remarkable functional achievements using SCiP in pediatric patients with cerebral palsy. This research demonstrated that non-invasive spinal neuromodulation enhanced voluntary sensory and motor coordination and function during an activity-based neurorehabilitation therapy (ABNT). The 16 subjects were in different age groups and had a varying severity of the disorder, yet all showed measurable improvement.
Cerebral Palsy is a neurological condition that generally impairs muscular coordination and mobility. Presently there are no treatments or drugs available to prevent or manage cerebral palsy. Babies with this neurological disorder are frequently left to undergo invasive procedures in an attempt to reduce spasticity (a typical symptom of the disorder.
The SCiP is a non-invasive device that administers transcutaneous spinal cord neuro-stimulation in order to effectively address the root cause of neurological dysfunctions in pediatric cerebral palsy patients. The first device of its kind, SCiP promises to reconstruct broken brain and spinal cord connections into highly operational systems.
SpineX received the Breakthrough Device Designation (BDD) from the US FDA for SCiP and the proposed treatment of cerebral palsy. Furthermore, SpineX have scheduled a proposed clinical trial to be undertaken in 2023, the findings of which are expected to contribute to FDA clearance of the SCiP technology for the management and treatment of cerebral palsy.