NCT06918119 Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
| NCT ID | NCT06918119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Myelomeningocele |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2028-07 |
Trial Parameters
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Brief Summary
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
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.