An interventional study of Transcutaneous stimulator in Spina Bifida and Myelomeningocele, sponsored by Bailey Petersen. Recruiting at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Bailey Petersen · Not applicable, Interventional, and Other
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.
Transcutaneous, or non-invasive, spinal cord stimulation (tSCS) has been effective at improving motor control, especially walking, in adults with a variety of neuromuscular disorders and in children with spinal cord injury. Children with spina bifida often have similar difficulties with walking, muscle strength and bladder control throughout their lives, with few effective therapies to reliably improve walking. In this pilot, the investigators will test if tSCS can improve motor deficits and bladder control in children with spina bifida. The investigators are enrolling up to 20 subjects with myelomeningocele, ages 4-17 years old, that have some difficulty walking but can walk for even short distances with assistance, and that have bladder dysfunction with a stable bladder regimen. Over 4-6 weeks, children will have stimulation using non-invasive tSCS electrodes placed on their low back. Similar protocols have been used for tSCS in children with spinal cord injury and children with cerebral palsy. All previous tSCS studies have shown that this is a safe technology for use with pediatric populations. This pilot study will be used to refine the design of future randomized controlled trials to test tSCS over standard physical therapy care.
Exclusion Criteria:
All participants will be receiving transcutaneous spinal cord stimulation
Device: Transcutaneous stimulator
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Muscle Strength
change in isometric torque of quadriceps during knee extension
Time frame: 4-6 weeks
Gait Kinematics
Change in joint angles in tSCS vs no stim conditions
Time frame: 4-6 weeks
Bladder capacity
Change in cystometric bladder capacity with tSCS vs no stim conditions
Time frame: 4-6 weeks
Gait Kinetics
Changes in ground reaction forces with and without stimulation
Time frame: 4-6 weeks
Bladder Pressure
Change in voiding pressure with tSCS vs no stim conditions
Time frame: 4-6 weeks
Plan to share: Yes — De-identified individual participant data collected during the trial may be shared with other researchers for the purpose of data analysis and collaboration.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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