RecruitingNot ApplicableNCT07615686
tSCS in Children With Spina Bifida
Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
Sponsor
Bailey Petersen
Enrollment
20 participants
Start Date
Jun 10, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 4 YearsMax Age: 17 Years
Inclusion Criteria5
- 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 Criteria6
- 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.
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Interventions
DEVICETranscutaneous stimulator
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07615686
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