← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07615686). StuddyBuddy aggregates publicly available trial information.