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

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

Study Overview

• Status: Recruiting
• Conditions: Myelomeningocele; Spina Bifida
• Intervention / Treatment: Device: Transcutaneous stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Block; Phone Number: 507-255-7393; Email: Block.Julie@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Kristin D Zhao, Ph.D; Phone Number: 507-284-8942; Email: Zhao.Kristin@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Transcutaneous stimulation; DS8R (Digitimer LLC) for transcutaneous neurostimulation.
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.	Device: Transcutaneous stimulation; DS8R (Digitimer LLC) for transcutaneous neurostimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography (EMG)	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.	1 to 12 visits (up to 6 weeks)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kristin Zhao, Ph.D., Mayo Clinic; Principal Investigator: Joline Brandenburg, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism; Meningomyelocele; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: 24-006063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No