Actively Recruiting
Characterization of Transcutaneous Spinal Cord Stimulation for Reflex Motor Responses in Children and Youth with Spina Bifida
Led by Mayo Clinic · Updated on 2025-10-14
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how transcutaneous spinal cord stimulation (TS) affects motor problems in children and youth with spina bifida, a condition present from birth. The study focuses on understanding weakness, coordination, and spasticity by measuring electrical activity and muscle responses. This approach aims to provide a detailed view of how the spinal cord connects to muscles and to explore a new therapy to strengthen weakened muscles in this young population. The study includes two groups based on age. Children aged 5 to 11 will receive a single multi-hour session of transcutaneous spinal cord stimulation applied to the skin over the lower spine, with muscle and movement responses recorded. Older participants aged 12 to 18 may take part in an extended program involving up to twelve multi-hour sessions of functional motor training combined with spinal cord stimulation over a six-week period. Participants will undergo assessments including manual muscle testing, spasticity evaluations, gait analysis, and coordination checks, all conducted across up to 12 visits within six weeks. Electromyography (EMG) will also be used to measure muscle electrical activity. These tests will help researchers understand the effects of stimulation on muscle function and movement. The study started in August 2025 and will continue until July 2030.
CONDITIONS
Brief Title
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Congenital diagnosis of myelomeningocele (MMC)
- Able to follow verbal commands or instructions
- For females able to become pregnant, willing to use medically acceptable contraception during study participation
You will not qualify if you...
- Severe cognitive deficits that prevent communication of needs
- Open wounds or unhealed skin near electrode placement site
- Unhealed fractures on load-bearing bones
- History of osteoporosis
- Implanted electronic devices near stimulation area (e.g., pacemaker, baclofen pump)
- Pregnancy
- Epilepsy or history of seizures
- Ongoing infections that are symptomatic or being treated
- Any condition that may affect safety, protocol compliance, or data validity as assessed by the research team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks
Participants receive transcutaneous spinal cord stimulation delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes during multi-hour sessions.
1 to 12 multi-hour visits depending on study arm
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Julie Block
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here