NCT06918119 · Mayo Clinic
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
What this study is about
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
View original scientific description
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
Interventions
DEVICE
Transcutaneous stimulation
DS8R (Digitimer LLC) for transcutaneous neurostimulation.
Primary outcome measures
Manual muscle testing (MMT)
Time frame: 1 to 12 visits (up to 6 weeks)
Measuring muscle strength and function using the Daniels and Worthingham's Muscle Grading Scale. A physical therapist will use a 5-point scale to manually test the 5 lower extremity muscles on each side, with 0 being no visible or palpable contraction, up to 5 being full range of motion against gravity with maximal resistance. The maximum total score would be 50.
Spasticity (1)
Time frame: 1 to 12 visits (up to 6 weeks)
Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone. MAS for 4 muscle groups in each leg will be reported.
Spasticity (2)
Time frame: 1 to 12 visits (up to 6 weeks)
Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with the first swing angle (FSA) degrees as the primary outcome. Fewer degrees on swing angle indicating greater spasticity.
Gait
Time frame: 1 to 12 visits (up to 6 weeks)
Gait speed will be quantified in m/sec utilizing a motion capture system, with faster gait speed indicating less impairment.
Coordination
Time frame: 1 to 12 visits (up to 6 weeks)
Coordination will be reported with the Selective Control Assessment of the Lower Extremity (SCALE) total limb score for both right and left leg. Total score for each limb is 10, with a higher score indicating coordination closer to optimal.
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
- Congenital diagnosis of myelomeningocele (MMC)
- Able to follow verbal commands or instructions.
- If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation.
Exclusion criteria
- Severe cognitive deficits demonstrating inability to communicate needs
- Gaping, weeping, or unhealed open wounds at the site of electrode placement
- Unhealed fractures on load bearing bones
- History of osteoporosis
- History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.)
- History of seizure
- Ongoing infections (currently being treated or are symptomatic)
- Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Where
- Rochester, Minnesota
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 Oct 14, 2025 · Source of record for eligibility and locations