NCT06918119

Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.

Detailed description

The study's goals involve understanding how transcutaneous stimulation affects motor deficits across three dimensions; weakness, coordination, and spasticity. This will be investigated by an electrophysiological characterization lower-extremity deficits, using TS to interrogate neuromotor topography and connectivity of the spinal cord to specific muscles. These evaluations will enable a unique patient-specific understanding of the electrophysiological mechanisms underlying motor deficits. Furthermore, these evaluations will assess the therapeutic potential of a novel closed-loop TS plasticity induction protocol to strengthen weakened muscles in a pediatric SB population.

Conditions

• Myelomeningocele
• Spina Bifida

Interventions

Type	Name	Description
DEVICE	Transcutaneous stimulation	DS8R (Digitimer LLC) for transcutaneous neurostimulation.

Timeline

• Start date: 2025-08-07
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2025-04-09
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study