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NCT Number: NCT06918119

Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Kristin D Zhao, Ph.D

CONTACT

[email protected]

507-284-8942

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)
  • Pregnancy
  • Epilepsy
  • 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.

Treatment and study plan

Transcutaneous stimulation

Device

DS8R (Digitimer LLC) for transcutaneous neurostimulation.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Electromyography (EMG)

    Time frame: 1 to 12 visits (up to 6 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Block

CONTACT

[email protected]

507-255-7393

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Apr 9, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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