Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

Launched by MAYO CLINIC · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called transcutaneous spinal cord stimulation, which involves using a device to send gentle electrical signals to the spine. The goal is to understand how this treatment can help children and young people with spina bifida, specifically those with a condition known as myelomeningocele. The trial is not yet recruiting participants, but it aims to include individuals aged 18 to 26 and 65 to 74 years, regardless of gender.

To be eligible for the study, participants must have a confirmed diagnosis of myelomeningocele and be able to follow instructions given by the researchers. However, individuals with severe cognitive difficulties, open wounds, unhealed fractures, or certain medical devices will not be able to participate for safety reasons. Participants will undergo assessments related to their condition and may learn more about how spinal stimulation can impact their sensorimotor abilities. This could provide valuable insights into potential new treatments for spina bifida.

Gender

ALL

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
• • 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.