This study discusses how delivering non-invasive spinal neuromodulation, using SCiP, during Physical Therapy improved voluntary sensorimotor function < https://www.youtube.com/watch?v=gY8QrbzVi1Q > in 16 out of 16 children over a wide range of ages and severities of CP. In May 2022 SpineX’s SCiP system received the FDA’s Breakthrough Device designation for treatment of cerebral palsy in children. In addition, SpineX has engaged with the 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 CP.
CP is the most common childhood motor disorder in the U.S., affecting an estimated 1 in 345 children. CP is severely debilitating with no current cure. CP is the result of damage to the developing brain and describes a group of movement disorders that affect a person’s ability to move and maintain balance and posture.
To date there are no methods or medications to prevent or treat CP. Often children with CP are left to be treated with invasive surgeries that attempt to decrease spasticity, a common symptom of the disease. 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 CP. SCiP aims to be the first medical device in the U.S. to treat CP by transforming the brain and spinal cord dysfunctional connectivity into highly functional systems.
Dana, the mother of a young boy diagnosed with CP who was enrolled in a clinical study sponsored by SpineX, remarked: “At just three years old and highly affected by CP, our son has shown such exciting progress since he began using SCiP. We’re so grateful that our son was included in the clinical study with SCiP as it has opened up a world of possibilities for our son, and we hope others will be able to witness it soon.”
Sharon Rosuck, mother of twin boys diagnosed with CP who were enrolled in a clinical study sponsored by SpineX, said: “In just three weeks, SCiP helped Ben and William gain so many new skills. SCiP will change the lives of so many families in ways that you wouldn’t even believe possible. SCiP makes the impossible possible and opens so many more doors of opportunity for the Cerebral Palsy community”.
Spinal Neuromodulation is being developed as a platform technology by SpineX and SCiP represents their second Breakthrough Device Designation following the SCONE device which is in clinical trials for the treatment of Neurogenic Bladder.