Actively Recruiting
Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
Led by Bailey Petersen · Updated on 2026-05-29
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effects of transcutaneous spinal cord stimulation (tSCS), a non-invasive electrical stimulation method, on improving leg muscle strength, walking ability, and bladder control in children with myelomeningocele, a form of spina bifida. This pilot trial involves children aged 4 to 17 years who have some difficulty walking but can walk short distances with assistance, and who have bladder dysfunction managed with a stable regimen. The study aims to refine methods for future larger trials comparing tSCS with standard physical therapy care. All participants will receive tSCS treatment using electrodes placed on the lower back over 4 to 6 weeks. The stimulation uses devices such as a TENS unit or Digitimer DS8R, applying similar electrical parameters. This approach has been safe in previous studies involving children with spinal cord injuries and cerebral palsy. The trial is open-label and conducted at a single center, with no placebo or comparison group. During the study, participants will be assessed for changes in muscle strength, walking patterns (gait kinematics and kinetics), bladder capacity, and bladder pressure over 4 to 6 weeks. Evaluations involve physical assessments and monitoring of bladder function while undergoing tSCS. The study includes up to 20 children and will provide data to guide future research. Safety and tolerability of the stimulation in this pediatric population are also monitored.
CONDITIONS
Brief Title
tSCS in Children With Spina Bifida
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist
- Some difficulty walking, but able to walk at least 10 meters with devices and/or assistance
- Between 4 and 17 years old
- Documented neurogenic bladder dysfunction
- On a stable bladder management regimen for at least 4 to 6 weeks before joining the trial
You will not qualify if you...
- Severe behavioral or cognitive impairments preventing participation
- Planned surgery for spina bifida impairments or surgery within last 6 months
- Pregnancy
- Open wounds on thoracic or lumbar spine that prevent stimulation
- Implanted or attached electronic devices anywhere in the body
- Current or symptomatic urinary tract infection, scheduled urological surgery, or inability to perform catheterization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 weeks
Participants receive transcutaneous spinal cord stimulation using non-invasive electrodes placed on their low back to improve motor deficits and bladder control.
Multiple visits during the stimulation period
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Sydney Bader, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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