An interventional study of Transcutaneous stimulation in Myelomeningocele and Spina Bifida, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
The study's goals involve understanding how transcutaneous stimulation affects motor deficits across three dimensions; weakness, coordination, and spasticity. This will be investigated by an electrophysiological characterization lower-extremity deficits, using TS to interrogate neuromotor topography and connectivity of the spinal cord to specific muscles. These evaluations will enable a unique patient-specific understanding of the electrophysiological mechanisms underlying motor deficits. Furthermore, these evaluations will assess the therapeutic potential of a novel closed-loop TS plasticity induction protocol to strengthen weakened muscles in a pediatric SB population.
58 studies on the registry are indexed under Meningomyelocele; 14 are open to participants now.
This study's planned enrollment of 30 is below the median of 35 across 41 interventional studies indexed under Meningomyelocele.
Browse Meningomyelocele studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcutaneous spinal cord stimulation will be delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes for ages 5-11 for one multi-hour visit. The effects of stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Device: Transcutaneous stimulation
An extended functional training arm for a subset of 10 subjects, ages 12-18, in which they will receive up to twelve multi-hour sessions of a therapeutic neuromuscular strengthening intervention within a 6 week period.
Device: Transcutaneous stimulation
DS8R (Digitimer LLC) for transcutaneous neurostimulation.
Manual muscle testing (MMT)
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.
Time frame: 1 to 12 visits (up to 6 weeks)
Spasticity (1)
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.
Time frame: 1 to 12 visits (up to 6 weeks)
Spasticity (2)
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.
Time frame: 1 to 12 visits (up to 6 weeks)
Gait
Gait speed will be quantified in m/sec utilizing a motion capture system, with faster gait speed indicating less impairment.
Time frame: 1 to 12 visits (up to 6 weeks)
Coordination
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.
Time frame: 1 to 12 visits (up to 6 weeks)
Electromyography (EMG)
TS-evoked motor potential (MEP) amplitude, in millivolts, will be reported for major lower limbs muscles. An increase in MEP amplitude is indicative of greater muscle activation, closer to optimal function.
Time frame: 1 to 12 visits (up to 6 weeks)
Plan to share: No — There are no plans to share individual participant data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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