SpineX has announced the publication of the results of its first in human study using its proprietary non-surgical and non-invasive device, SCiP, to treat children with cerebral palsy.
SCiP is a non-invasive spinal electrical neuromodulation device which provides transcutaneous spinal cord neuro-stimulation to potentially treat the underlying neurological dysfunction in paediatric patients with cerebral palsy.
The study, which was led by Susan Hastings (San Jose, USA) and V Reggie Edgerton (Los Angeles, USA) was published in the Nature Communications journal and demonstrated unparalleled functional improvements with the device in children with cerebral palsy, say SpineX.
This study discusses how delivering non-invasive spinal neuromodulation, using SCiP, during physical therapy improved voluntary sensorimotor function in 16 out of 16 children over a wide range of ages and severities of cerebral palsy.
SpineX was awarded breakthrough device designation by the US Food and Drug Administration (FDA) for SCiP and the proposed treatment of cerebral palsy. In addition, SpineX states that it has engaged with FDA to gain alignment on a proposed clinical trial to be conducted in 2023; the results of which are anticipated to lead to FDA clearance of the SCiP device for the treatment of cerebral palsy, say the company.