July 2023 issue
July 31, 2023 | Among all the neurological and neuromuscular diseases and disorders, cerebral palsy represents a significant untapped potential for neurotech vendors. Although the Bioness L300 system received FDA clearance for treating foot-drop in children with CP in 2013, there have been few neurotech approaches to treat the underlying cause.
CP is the most common of all childhood disabilities, with about 500,000 children and more than 250,000 adults in the U.S. living with the disease. It’s caused by abnormal neural connectivity between the brain and spinal cord, and affects motor function, impeding the ability to move voluntarily, and causing inability or difficulty walking and other day-to-day challenges.
Earlier this month, a team of researchers affiliated with Los Angeles neurorehabilitation firm SpineX announced the publication this month of two new peer-reviewed publications, both in Frontiers.
The researchers tested the efficacy of the company’s noninvasive spinal cord neuromodulation system, SCiP, with activity-based neurorehabilitation therapy in improving the sensorimotor function in six children with CP. Subjects received 8 weeks of either SCiP or sham therapy with ABNT. Follow up assessments were done at week 26 They observed minimal change in the sham group (mean 6% improvement), however, eight weeks of SCiP therapy with ABNT resulted in statistically and clinically relevant improvement (mean 23% increase from baseline).
The authors hypothesized that spinal neuromodulation transforms targeted spinal-supraspinal neural networks into an activated state of plasticity, which are made functionally more competent using activity dependent guidance obtained from proprioception
“Having our research validated by our peers and published in Frontiers is an honor, and also a testament to the innovation driving this work,” said SpineX CEO Parag Gad. “Thanks to this research, we can now confidently say that consistent, ongoing noninvasive spinal cord neuromodulation results in demonstrable improvement of sensorimotor function in children with CP.”
SpineX is applying its neuromodulation technology to amplify the correct neural signals in order to help the patient better control muscle movement. The company’s SCiP device targets the abnormal connectivity between brain and spinal cord, thereby treating the root causes of CP. SpineX plans on conducting a multisite trial starting in 2024 following which it will approach the FDA for regulatory approval.
“Our experience with SCiP has been a true game-changer for our child,” said Jessica and Van Oldham, whose nine-year old daughter Annika lives with CP. “When she started her first series of therapy sessions, we saw almost immediate results. She went from using a walker or crutches almost exclusively to standing up straighter and using just one crutch/walking stick. She has also begun to walk independently in our home.”
Annika received SCiP over two near-consecutive therapy sessions, one of 16 weeks and the other of 10 weeks duration. The therapy is non-invasive and pain-free, making it ideal for treating children and adults.
“As parents of a child with CP it’s a bit like fitting together a puzzle,” said Annika’s mother, Jess. “This is a very large piece of the puzzle; we saw more positive change in our daughter over the two courses of SCiP therapy than we did in the first seven years of her life. She says she feels more aligned and is literally taking bigger steps all the time.”
