Spina BifidaChildren's healthDevice
What this study is
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.
What's being tested
- Transcutaneous stimulator
Intervention · DEVICE
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Study details
- Official title
- Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
- Sponsor
- Bailey Petersen
- Conditions
- Spina Bifida · Myelomeningocele
- Enrolling
- 20 people
- Starts
- 2026-09-30
- Est. completion
- 2029-03-10
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 4 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Sydney Bader, MS · Contactsyb17@pitt.edu
Recruiting
Study team
Sponsor
Bailey Petersen
Study ID STUDY25100066
Principal investigator
Bailey Petersen, PhD
University of Pittsburgh
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.