University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
NCT Number: NCT07615686
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.
Interested in participating?
Request Info4 year–17 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Time frame: 4-6 weeks
change in isometric torque of quadriceps during knee extension
Time frame: 4-6 weeks
Change in joint angles in tSCS vs no stim conditions
Time frame: 4-6 weeks
Change in cystometric bladder capacity with tSCS vs no stim conditions
Time frame: 4-6 weeks
Changes in ground reaction forces with and without stimulation
Time frame: 4-6 weeks
Change in voiding pressure with tSCS vs no stim conditions
Contact information is provided by the study sponsor or research team.
Bailey Petersen
Other
Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
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