Transcutaneous spinal stimulation for children and teens with spina bifida

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06918119 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Kristin Zhao, Ph.D. — Mayo Clinic
• Study coordinator: Julie Block

Conditions: Myelomeningocele, Spina Bifida