Recruiting

Transcutaneous Spinal Cord Stimulation

Sponsor:

Mayo Clinic

Code:

NCT06918119

Conditions

Myelomeningocele

Spina Bifida

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Transcutaneous stimulation

Study Details

Brief summary:

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

Conditions

Myelomeningocele

Spina Bifida

Study ID

NCT06918119

Start date

Aug 7, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Functional motor training with transcutaneous spinal cord stimulation

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.

experimental: Extended functional motor training with transcutaneous spinal cord 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.

Interventions

Transcutaneous stimulation

DS8R (Digitimer LLC) for transcutaneous neurostimulation.

Primary outcome measure

  • Manual muscle testing (MMT) [ Time Frame: 1 to 12 visits (up to 6 weeks) ]
  • Spasticity (1) [ Time Frame: 1 to 12 visits (up to 6 weeks) ]
  • Spasticity (2) [ Time Frame: 1 to 12 visits (up to 6 weeks) ]
  • Gait [ Time Frame: 1 to 12 visits (up to 6 weeks) ]
  • Coordination [ Time Frame: 1 to 12 visits (up to 6 weeks) ]

Central Contacts and Locations

Central contacts

Julie Block

507-255-7393Block.Julie@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kristin D Zhao, Ph.D

507-284-8942Zhao.Kristin@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-14.