tSCS for improving leg strength and walking in kids with spina bifida
Official title: Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
Run by University of Pittsburgh · NCT07615686 · Data updated 2026-11-12
This pilot test will try non-invasive transcutaneous spinal cord stimulation to see if it helps improve leg muscle strength and walking in children with myelomeningocele who can walk a little with help.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 17 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | March 10, 2028 |
| Study ends | March 10, 2029 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07615686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4–17 with myelomeningocele who have some walking difficulty and stable, documented neurogenic bladder dysfunction.
✕Probably not a fit
Children with severe cognitive/behavioral issues or those undergoing recent spinal or orthopedic surgery may not benefit, and non-responders to stimulation are possible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, open-label pilot study enrolling up to 20 children aged 4–17 with myelomeningocele and some ambulation difficulty. The study uses non-invasive transcutaneous spinal cord stimulation (tSCS) applied to the lower back for 4–6 weeks while participants continue usual care, with the goal of improving motor deficits and bladder function. Prior work in other pediatric populations suggests tSCS can be safe and may enhance motor control, guiding plans for future randomized trials. Outcomes will help refine study design and feasibility for evaluating tSCS as an adjunct to therapy in spina bifida.
Why it matters
Potential benefit: If successful, participants may experience improvements in leg strength, walking ability, and bladder control.
How similar studies have gone: Previous tSCS work in children with spinal conditions and cerebral palsy has shown safety and potential motor benefits, informing this pilot.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist * Some difficulty ambulating, but able to ambulate at least a short distance (10 meters) with devices and/or assistance. * Between the ages of 4 and 17 years of age. * Documented neurogenic bladder dysfunction * On a stable bladder management regimen at least 4-6 weeks prior to the enrollment in the trial Exclusion Criteria: * Severe behavioral or cognitive impairments that preclude participation in the study, in the opinion of the investigator. * Has an active surgery planned for impairments from spina bifida (e.g. tethered cord syndrome surgery or orthopedic surgery) or has had surgery in the last 6 months. * Is pregnant. Pregnancy will be assessed via verbal report. * Open wounds at the thoracic or lumbar spine that precludes transcutaneous stimulation. * Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, or implanted insulin pumps) * Symptomatic urinary tract infection, urinary tract infection for which they are currently receiving treatment, scheduled urological surgery, or inability to perform or receive catheterization.
Where it's running
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Bailey Petersen, PhD — University of Pittsburgh
- Study coordinator: Sydney Bader, MS
- Email: syb17@pitt.edu
- Phone: 412-648-4196
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.