Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

NCT06918119 | Recruiting DMC FDA Device

• 1 other identifier: 24-006063
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  1 to 12 visits (up to 6 weeks)

Secondary Outcomes (1)

• Electromyography (EMG)

  1 to 12 visits (up to 6 weeks)

Study Arms (2)

Functional motor training with transcutaneous spinal cord stimulation

EXPERIMENTAL

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

Extended functional motor training with transcutaneous spinal cord stimulation

EXPERIMENTAL

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

Interventions

Transcutaneous stimulation DEVICE

DS8R (Digitimer LLC) for transcutaneous neurostimulation.

Extended functional motor training with transcutaneous spinal cord stimulation; Functional motor training with transcutaneous spinal cord stimulation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Meningomyelocele; Spinal Dysraphism

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Kristin Zhao, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Joline Brandenburg, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Block

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)