RecruitingNot ApplicableNCT06918119

Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

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


Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 5 YearsMax Age: 18 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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.

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Interventions

DEVICETranscutaneous stimulation

DS8R (Digitimer LLC) for transcutaneous neurostimulation.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06918119


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