SpineX received breakthrough device designation from the FDA for the SCiP device for children with cerebral palsy in May 2022. Image credit: Shutterstock/Yurchanka Siarhei.

SpineX has announced positive results from a first-in-human study evaluating the use of its electrical neuromodulation device in a patient with cerebral palsy.

The results, which were published in BioElectronic Medicine, showed significant functional improvements in a 60-year-old woman with the neurodevelopmental disorder who did not adequately respond to previous treatments, according to a 3 January press release.

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After eight weeks of using SpineX’s Spinal Cord Innovation in Pediatrics (SCiP) therapy, the patient had a 14.2-point increase in gross motor function as measured by the Gross Motor Function Classification System (GMFM) score.

The participant achieved a Minimal Clinically Important Difference (MCID) score of five points and gained activities such as kneeling, sitting, and walking functions, as per the research paper. Motor improvement persisted at the 20-week follow-up post-therapy.

The patient said: “After eight weeks of SCiP therapy, my balance was better, I was more confident in walking and climbing stairs with minimal assistance and was able to get dressed in less than half my usual time.”

Previous pilot studies investigating the device in children with cerebral palsy have demonstrated significant improvement in motor function. The researchers stated that the early positive results from the current study support potential use in adults with cerebral palsy.

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The company secured funding from the National Institutes of Health to conduct a pivotal trial in children, with recruitment expected to start in the first half of this year. SpineX already had discussions with the US Food and Drug Administration (FDA) to align on the proposed clinical trial.

SpineX received an FDA breakthrough device designation for the SCiP device for children with cerebral palsy in May 2022. The company also has another breakthrough device designation for its other neuromodulation device for the treatment of neurogenic bladder. SpineX said it was close to full recruitment in a pivotal trial for the device, called SCONE, last month.

A market model by GlobalData estimates the global neuromodulation device market will be worth $11.4bn by 2033, up from $6bn in 2022.

GlobalData is the parent company of Clinical Trials Arena.