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Recruiting NCT07615686

tSCS in Children With Spina Bifida

Conditions: Spina Bifida, Myelomeningocele

Sex: All
Ages: 4 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Bailey Petersen

Location: University of Pittsburgh Pittsburgh Pennsylvania

Summary

A single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07615686). StuddyBuddy aggregates publicly available trial information.