NCT07615686 · Bailey Petersen
tSCS in Children With Spina Bifida
What this study is about
A single-center, where both patients and doctors know the treatment given, experimental pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.
View original scientific description
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.
Interventions
DEVICE
Transcutaneous stimulator
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Primary outcome measures
Muscle Strength
Time frame: 4-6 weeks
change in isometric torque of quadriceps during knee extension
Gait Kinematics
Time frame: 4-6 weeks
Change in joint angles in tSCS vs no stim conditions
Bladder capacity
Time frame: 4-6 weeks
Change in cystometric bladder capacity with tSCS vs no stim conditions
Gait Kinetics
Time frame: 4-6 weeks
Changes in ground reaction forces with and without stimulation
Bladder Pressure
Time frame: 4-6 weeks
Change in voiding pressure with tSCS vs no stim conditions
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations