Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

Last updated: June 10, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Transcutaneous stimulation

Clinical Study ID

NCT06918119
24-006063
  • Ages 5-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

  • 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.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Transcutaneous stimulation
Phase:
Study Start date:
July 01, 2025
Estimated Completion Date:
July 31, 2030

Study Description

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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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