Status:
RECRUITING
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Lead Sponsor:
Mayo Clinic
Conditions:
Myelomeningocele
Spina Bifida
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief 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 electroph...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06918119
Start Date
August 7 2025
End Date
July 1 2030
Last Update
October 14 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905