Transcutaneous spinal stimulation for children and teens with spina bifida
Official title: Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida
Run by Mayo Clinic · NCT06918119 · Data updated 2026-11-12
This study will try gentle, non-invasive electrical stimulation of the spinal cord to see if it can strengthen legs and improve movement in children and teens with spina bifida.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | August 7, 2025 |
| Main results expected | July 2028 |
| Study ends | July 2030 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06918119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents with a congenital diagnosis of myelomeningocele who can follow instructions and do not have implanted electronic devices, active infections, open wounds at electrode sites, unhealed load-bearing fractures, osteoporosis, pregnancy, or uncontrolled seizure disorders.
✕Probably not a fit
Patients with severe cognitive impairment who cannot communicate or follow instructions, those with implanted electronic devices near the stimulation site, active infections or open wounds at electrode sites, unhealed fractures, osteoporosis, pregnancy, or a history of seizures are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses non-invasive transcutaneous spinal cord stimulation to map and characterize sensorimotor deficits in children and youth with myelomeningocele. Researchers will record electrophysiological responses from lower-extremity muscles to define neuromotor topography and quantify weakness, coordination problems, and spasticity. The protocol includes a novel closed-loop stimulation method intended to induce neural plasticity and strengthen weakened muscles. Results will produce patient-specific maps of spinal-muscle connectivity and explore whether this stimulation approach can improve motor function in pediatric spina bifida.
Why it matters
Potential benefit: If successful, the approach could strengthen weakened leg muscles and improve coordination and spasticity, leading to better mobility and function.
How similar studies have gone: Non-invasive spinal stimulation has shown promising motor improvements in adults and some pediatric reports, but closed-loop transcutaneous protocols specifically for children with spina bifida are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Congenital diagnosis of myelomeningocele (MMC) * Able to follow verbal commands or instructions. * If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation. Exclusion Criteria * Severe cognitive deficits demonstrating inability to communicate needs * Gaping, weeping, or unhealed open wounds at the site of electrode placement * Unhealed fractures on load bearing bones * History of osteoporosis * History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.) * Pregnancy * Epilepsy * History of seizure * Ongoing infections (currently being treated or are symptomatic) * Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Kristin Zhao, Ph.D. — Mayo Clinic
- Study coordinator: Candee Mills
- Email: Mills.Candee@mayo.edu
- Phone: 507-255-7253
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.